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Archive for the ‘Nutritional Supplements: Atherogenesis, lipid metabolism’ Category


PEER-REVIEWED MEDICAL JOURNAL PUBLISHES LANDMARK STUDY ON EFFICACY AND SAFETY OF FDgard® (COLM-SST), DEMONSTRATING RAPID REDUCTION OF FUNCTIONAL DYSPEPSIA (FD OR RECURRING, MEAL-TRIGGERED INDIGESTION) SYMPTOMS WITHIN 24 HOURS

  • FDgard® (COLM-SST), a solid-state microsphere formulation of caraway oil and l-Menthol, taken daily and proactively 30-60 minutes before meals, showed statistically significant, rapid reduction of Functional Dyspepsia (FD) symptoms within 24 hours and, additionally, relief of severe FD symptoms.
  • FDREST clinical trial with FDgard represents an important medical advance, as no previous trials have shown rapid relief of FD symptoms. There are no approved products for this highly prevalent condition.
  • In FDREST, patients received greater and more durable benefits with the addition of FDgard taken daily and proactively to their typical medical regimen.
  • FDREST is the first clinical trial in FD to use patented, Site Specific Targeting (SST®) technology to deliver the FDgard formulation to the upper belly (duodenum), the primary site of disturbance in FD.
  • FDgard represents an effective, safe and well-tolerated option to address the unmet medical needs of millions of adults with FD.

Reporter: Gail S. Thornton

Boca Raton Fl., – (April 30, 2019) – IM HealthScience today announced that Clinical and Translational Gastroenterology (CTG), a peer-reviewed medical journal, has published the U.S. results of a landmark, double-blind, placebo-controlled study, FDREST™ (Functional Dyspepsia Reduction Evaluation and Safety Trial), which showed statistically significant, rapid reduction of Functional Dyspepsia (FD or recurring, meal-triggered indigestion) symptoms within 24 hours and, additionally, relief of severe FD symptoms.

The study, entitled “A Novel, Duodenal-Release Formulation of a Combination of Caraway Oil and L-Menthol for the Treatment of Functional Dyspepsia: A Randomized Controlled Trial,” is now available to the public via open access on the Clinical and Translational Gastroenterology website. Clinical and Translational Gastroenterology, published on behalf of the American College of Gastroenterology (ACG), is dedicated to innovative clinical work in the field of gastroenterology and hepatology.

The FDREST study demonstrated that patients who took COLM-SST (FDgard®) on a daily and proactive basis, 30 to 60 minutes before meals, along with commonly used off-label FD medications versus patients who took placebo along with commonly used off-label FD medications, experienced a statistically significant, rapid reduction of FD symptoms within 24 hours across the FD study population.

This study had a higher hurdle than previous studies on a similar combination of ingredients. Firstly, concomitant medications for FD symptoms were allowed in order to assess FDgard in a real-world setting. Second, only a subgroup of patients in FDREST was categorized into the high-symptom burden, while they constituted the entire groups in previous studies. Among this subgroup of patients with the high-symptom burden, FDgard showed efficacy at 24 hours. In spite of the polypharmacy and use of rescue medications for FD, after 48 hours of first dose, FDgard helped further improve symptoms at 4 weeks, especially in those high-symptom burden patients. In all cases, FDgard was safe and well-tolerated.  

The study results of FDREST were first presented at Digestive Disease Week (DDW), the largest gathering of gastroenterologists, in May 2017.

Study Commentary

Commenting on the study, lead author William Chey, M.D., FACG, Director in the Division of Gastroenterology, Michigan Medicine Gastroenterology Clinic, Ann Arbor, said, “This landmark study was designed to answer a very important scientific question about the effectiveness, safety, and tolerability of a novel and innovative formulation of caraway oil and l-Menthol designed as solid state, enteric coated microspheres for targeted duodenal release for FD. In patients taking their usual medications for FD, FDgard was found to be effective, safe and well tolerated in rapidly reducing symptoms and in relieving severe symptoms.” Chey continued, “The positive finding at 24 hours is clinically important as symptoms are often triggered by a meal and patients are looking for rapid relief of those symptoms.”

The study authors also cited the importance of utilizing the microsphere-based site-specific targeting of FDgard (caraway oil and l-Menthol, the active ingredient in peppermint oil) to the duodenum. They wrote, “This site (duodenum) was targeted primarily due to mounting evidence that gastroduodenal mucosal integrity and low-grade inflammation play a role in FD. Furthermore, studies have shown that caraway oil and peppermint oil act on the duodenum to induce smooth muscle relaxation, and that l-Menthol has anti-inflammatory effects.” This may help normalize motility effects.

About FDREST™

FDREST™ (Functional Dyspepsia Reduction and Evaluation Safety Trial) was a multi-centered, post-marketing, parallel group, U.S-based study conducted at seven university-based or gastroenterology research-based centers (study period July 1, 2015, to September 14, 2016). The study was designed to compare the efficacy, safety and tolerability of FDgard plus commonly used, off-label medications for FD vs. a control group of placebo plus commonly used, off-label medications prescribed for FD.

Ninety-five patients were enrolled (mean age = 43.4 years; 75.8 percent women). At 24 hours, the active arm reported a statistically significant reduction in Postprandial Distress Syndrome (PDS) symptoms (P = 0.039), and a nonsignificant trend toward benefit of Epigastric Pain Syndrome (EPS) symptoms (P = 0.074). In patients with more severe symptoms, approximately three-quarters showed substantial global improvement (i.e., clinical global impressions) after 4 weeks of treatment vs. half in the control arm. These differences were statistically significant for patients with EPS symptoms (epigastric pain or discomfort and burning) (P = 0.046), and trending toward significance for patients with PDS symptoms (early satiety, abdominal heaviness, pressure and fullness) (P = 0.091). There were no statistically significant differences between groups for Global Overall Symptom scores for the overall population at 2 and 4 weeks.

Dr. Chey said, “The results of this high-quality study highlight an advance in the management of FD, as current off-label medications such as PPIs, H2RAs and antidepressants offer only a modest level of therapeutic gain over placebo and may be associated with adverse events, especially with continued use. FDgard addresses a significant unmet medical need for a product to help manage symptoms in the 1 in 6 adults suffering from this common disorder.”

About Functional Dyspepsia (FD)

Functional dyspepsia is a very common disorder affecting 11 percent – 29.2 percent of the world’s population1, making it comparable in prevalence to IBS. However, unlike IBS, there is no FDA approved product to treat FD. Sufferers are often treated off-label with prescribed proton pump inhibitors (PPIs), histamine type-2 receptor antagonists (H2RAs), antidepressants, and prokinetics. While offering relief to a portion of FD patients, some of these have been associated with adverse events. Functional dyspepsia can have a negative effect on workplace attendance and productivity, with associated costs estimated in excess of $18 billion annually.2

In FD, which is typically recurring, meal-triggered indigestion with no known organic cause, the normal digestive processes are disrupted along with digestion and absorption of food nutrients. FD is accompanied by symptoms such as epigastric pain or discomfort, epigastric burning, postprandial fullness, inability to finish a normal sized meal, heaviness, pressure, bloating in the upper abdomen, nausea, and belching. When doctors diagnose FD, they often identify patients as those who have these symptoms for at least three months, with symptom onset six months previously.

About FDgard®

FDgard® is a nonprescription medical food designed to address the unmet medical need for products to help manage Functional Dyspepsia (FD or recurring, meal-triggered indigestion) and its accompanying symptoms.  FDgard capsules contain caraway oil and l-Menthol, the primary component in peppermint oil, for the dietary management of FD. These two main ingredients are specially formulated to be available in a solid state.  With patented Site Specific Targeting (SST®) technology pioneered by IM HealthScience, FDgard capsules release individually triple-coated, solid-state microspheres of caraway oil and l-Menthol quickly and reliably where they are needed most in FD — the duodenum or upper belly. The l-Menthol helps with smooth muscle relaxation and provides analgesic and anti-inflammatory activities.3–5 Caraway oil helps mitigate the effect of gastric acid on the stomach wall and also helps to normalize gallbladder function and may help to normalize motility in the small intestine (primarily the duodenum) and in the stomach.6,7 In addition to caraway oil and l-Menthol, FDgard also provides fiber and amino acids (from gelatin protein). These ingredients have additional positive effects on the gut wall and thus help toward normalizing digestion and absorption.            

Caraway oil and peppermint oil have a history of working in FD. In multiple clinical studies, the combination of caraway oil and peppermint oil has been shown to manage FD and its accompanying symptoms, such as reducing the intensity of epigastric pain, pain frequency, dyspeptic discomfort, and the intensity of sensations of pressure, abdominal heaviness and fullness significantly better than control.8,9 Cisapride, no longer an FDA-approved pro-motility drug after its removal from the market in 2000 due to cardiovascular side effects, was shown to have efficacy similar to a caraway oil/peppermint oil formulation10.

Complete and final results from a real-world, observational study of 600 patients who took FDgard, called FDACT™ (Functional Dyspepsia Adherence and Compliance Trial), were selected after peer review and presented by William D. Chey, M.D., FACG, at the World Congress of Gastroenterology at ACG 2017 in Orlando, Florida. The data showed there was a consistently high level of patient satisfaction and rapid improvement of FD symptoms with the product. A majority of patients (95 percent) reported major or moderate improvement in their overall FD symptoms, while many patients (86.4 percent) indicated experiencing relief from symptoms within 2 hours after taking FDgard. The findings from FDACT substantiate the data reported in FDREST.

The usual adult dose of FDgard is 2 capsules, as needed, up to two times a day, not to exceed six capsules per day. Many physicians are now recommending taking FDgard daily and proactively 30-60 minutes before a meal, as this enables the supportive effect of FDgard to start as early as possible. While FDgard does not require a prescription and is available in retail outlets and online, it is a medical food that should be used under medical supervision.

About IM HealthScience®

IM HealthScience® (IMH) is the innovator of IBgard®and FDgard®for the dietary management of Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD or recurring, meal-triggered indigestion), respectively. In 2017, IMH added Fiber Choice®, a line of prebiotic fibers, to its product line via an acquisition. The sister subsidiary of IMH, Physician’s Seal®, also provides REMfresh®,

a well-known continuous release and absorption melatonin (CRA-melatonin™) supplement for sleep.

IMH is a privately held company based in Boca Raton, Florida. It was founded in 2010 by a team of highly experienced pharmaceutical research and development and management executives. The company is dedicated to developing products to address overall health and wellness, especially in digestive health conditions with a high unmet medical need. The IM HealthScience advantage comes from developing products based on its patented, targeted-delivery technologies called Site Specific Targeting (SST). For more information, visit www.imhealthscience.com to learn about the company, or www.IBgard.com,

 www.FDgard.com, www.FiberChoice.com, and www.Remfresh.com.

References

1.        Mahadeva S, Goh KL. Epidemiology of functional dyspepsia. A global perspective. World J Gastroenterol. 2006. doi:10.3748/wjg.v12.i17.2661.

2.        Lacy BE, Weiser KT, Kennedy AT, Crowell MD, Talley NJ. Functional dyspepsia: the economic impact to patients. Aliment Pharmacol Ther. 2013;38(May):170-177. doi:10.1111/apt.12355.

3.        Amato A, Liotta R, Mulè F. Effects of menthol on circular smooth muscle of human colon: Analysis of the mechanism of action. Eur J Pharmacol. 2014. doi:10.1016/j.ejphar.2014.07.018.

4.        Liu B, Fan L, Balakrishna S, Sui A, Moris JB, Jordt S-E. TRPM8 is the Principal Mediator of Menthol-induced Analgesia of Acute and Inflammatory Pain. Pain. 2013;154(10):2169-2177. doi:10.1016/j.pain.2013.06.043.TRPM8.

5.        Juergens U, Stober M, Vetter H. The anti-inflammatory activity of L-menthol compared to mint oil in human monocytes in vitro: a novel perspective for its therapeutic use in inflammatory diseases. Eur J Med Res. 1998;3(12):539-545.

6.        Alhaider A, Al-Mofleh I, Mossa J, Al-Sohaibani M, Rafatullah S, Qureshi S. Effect of Carum carvi on experimentally induced gastric mucosal damage in Wistar albino rats. Int J Pharmacol. 2006;2(3):309-315.

7.        Micklefield G, Jung O, Greving I, May B. Effects of intraduodenal application of peppermint oil (WS 1340) and caraway oil (WS 1520) on gastroduodenal motility in healthy volunteers. Phyther Res. 2003;17:135-140. doi:10.1002/ptr.1089.

8.        May B, Köhler S, Schneider B. Efficacy and tolerability of a fixed combination of peppermint oil and caraway oil in patients suffering from functional dyspepsia. Aliment Pharmacol Ther. 2000;14:1671-1677. doi:10.1046/j.1365-2036.2000.00873.x.

9.        Rich G, Shah A, Koloski N, et al. A randomized placebo-controlled trial on the effects of Menthacarin, a proprietary peppermint- and caraway-oil-preparation, on symptoms and quality of life in patients with functional dyspepsia. Neurogastroenterol Motil. 2017;29(May):e13132. doi:10.1111/nmo.13132.

10.      Madisch A, Heydenreich C, Wieland V, Hufnagel R, Hotz J. Treatment of Functional Dyspepsia with a Fixed Peppermint Oil and Caraway Oil Combination Preparation as Compared to Cisapride – A multicenter, reference-controlled double-blind equivalence study. Arzneimittelforsch Drug Res. 1999;49(II):925-932.

This information is for educational purposes only and is not meant to be a substitute for the advice of a physician or other health care professional. This information should not be used for diagnosing a health problem or disease. While medical foods do not require prior approval by the FDA for marketing, they must comply with regulations. It should not be assumed that medical foods are alternatives for FDA-approved drugs. Only doctors can definitively diagnose functional dyspepsia. Use under medical supervision. The company will strive to keep information current and consistent but may not be able to do so at any specific time. Generally, the most current information can be found on www.fdgard.com. Individual results may vary.

Other related articles were published in this Open Access Online Scientific Journal include the following:

2017

Series D: BioMedicine & Immunology https://pharmaceuticalintelligence.com/biomed-e-books/series-d-e-books-on-biomedicine/

2015

The relationship of stress hypermetabolism to essential protein need

https://pharmaceuticalintelligence.com/2015/10/25/the-relationship-of-stress-hypermetabolism-to-essential-protein-needs/

Liposomes, Lipidomics and Metabolism

https://pharmaceuticalintelligence.com/2015/11/02/liposomes-lipidomics-and-metabolism/

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Hypertriglyceridemia: Evaluation and Treatment Guideline

Reporter and Curator: Dr. Sudipta Saha, Ph.D.

 

Severe and very severe hypertriglyceridemia increase the risk for pancreatitis, whereas mild or moderate hypertriglyceridemia may be a risk factor for cardiovascular disease. Individuals found to have any elevation of fasting triglycerides should be evaluated for secondary causes of hyperlipidemia including endocrine conditions and medications. Patients with primary hypertriglyceridemia must be assessed for other cardiovascular risk factors, such as central obesity, hypertension, abnormalities of glucose metabolism, and liver dysfunction. The aim of this study was to develop clinical practice guidelines on hypertriglyceridemia.

The diagnosis of hypertriglyceridemia should be based on fasting levels, that mild and moderate hypertriglyceridemia (triglycerides of 150–999 mg/dl) be diagnosed to aid in the evaluation of cardiovascular risk, and that severe and very severe hypertriglyceridemia (triglycerides of >1000 mg/dl) be considered a risk for pancreatitis. The patients with hypertriglyceridemia must be evaluated for secondary causes of hyperlipidemia and that subjects with primary hypertriglyceridemia be evaluated for family history of dyslipidemia and cardiovascular disease.

The treatment goal in patients with moderate hypertriglyceridemia should be a non-high-density lipoprotein cholesterol level in agreement with National Cholesterol Education Program Adult Treatment Panel guidelines. The initial treatment should be lifestyle therapy; a combination of diet modification, physical activity and drug therapy may also be considered. In patients with severe or very severe hypertriglyceridemia, a fibrate can be used as a first-line agent for reduction of triglycerides in patients at risk for triglyceride-induced pancreatitis.

Three drug classes (fibrates, niacin, n-3 fatty acids) alone or in combination with statins may be considered as treatment options in patients with moderate to severe triglyceride levels. Statins are not be used as monotherapy for severe or very severe hypertriglyceridemia. However, statins may be useful for the treatment of moderate hypertriglyceridemia when indicated to modify cardiovascular risk.

 

References:

 

https://www.medpagetoday.com/clinical-connection/cardio-endo/77242?xid=NL_CardioEndoConnection_2019-01-21

https://www.ncbi.nlm.nih.gov/pubmed/19307519

https://www.ncbi.nlm.nih.gov/pubmed/23009776

https://www.ncbi.nlm.nih.gov/pubmed/6827992

https://www.ncbi.nlm.nih.gov/pubmed/22463676

https://www.ncbi.nlm.nih.gov/pubmed/17635890

 

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Micronutrients, Macronutrients and Dietary Patterns: Nutrition and Fertility

Reporter: Aviva Lev-Ari, PhD, RN

Folic acid. Folic acid is important for germ cell production and pregnancy. The recommended daily dose to prevent neural tube defects is 400-800 µg. Women who take folic acid-containing multivitamins are less likely to be anovulatory, and the time to achieve a pregnancy is reduced. Those who consume more than 800 µg of folic acid daily are more likely to conceive with assisted reproductive technology (ART) than those whose daily intake is less than 400 µg.

Vitamin D. Vitamin D may affect fertility through receptors found in the ovaries and endometrium. An extremely low vitamin D level (< 20 ng/mL) is associated with higher risk for spontaneous miscarriage risk. Some reports suggest that women with adequate vitamin D levels (> 30 ng/mL) are more likely to conceive after ART when compared with those whose vitamin D levels are insufficient (20-30 ng/mL), or deficient (< 20 ng/mL). These findings, however, are inconclusive.

Carbohydrates. Dietary carbohydrates affect glucose homeostasis and insulin sensitivity, and by these mechanisms can affect reproduction. The impact is most pronounced among women with polycystic ovary syndrome (PCOS). In women with PCOS, a reduction in glycemic load improves insulin sensitivity as well as ovulatory function. Whole grains have antioxidant effects and also improve insulin sensitivity, thereby positively influencing reproduction.

Omega-3 supplements. Omega-3 polyunsaturated fatty acids lower the risk for endometriosis. Increased levels of omega-3 polyunsaturated fatty acids are associated with higher clinical pregnancy and live birth rates.

Protein and dairy. Some reports suggest that dairy protein intake lowers ovarian reserve. Other reports suggest improved ART outcomes with increased dairy intake. Meat, fish, and dairy products, however, can also serve as vehicles for environmental contamination that may adversely affect the embryo. Fish, on the other hand, has been shown to exert positive effects on fertility.

Dietary approach. In general, a Mediterranean diet is favored (high intake of fruits, vegetables, fish, chicken, and olive oil) among women diagnosed with infertility.

Recommendations

A well-balanced diet, rich in vegetables and fruits, is preferred for infertile women and should provide the required micro- and macronutrients. It remains common for patients consume a wide variety of vitamin, mineral, and micronutrient supplements daily.[4] Supplements should not replace food sources of vitamins and trace elements because of differences in bioavailability (natural versus synthetic), and inaccuracy of label declarations may result in suboptimal intake of important nutrients.[5,6] Furthermore, naturally occurring vitamins and micronutrients are more efficiently absorbed.

With respect to overall diet, women are advised to follow a caloric intake that won’t contribute to being overweight or obese. Obesity is on the rise among younger people, including children. Obese women have a lower chance of conceiving and are less likely to have an uncomplicated pregnancy.[7] Proper weight can be maintained with an appropriate diet and regular exercise.

Finally, women must abstain from substances that are potentially harmful to pregnancy (eg, smoking, alcohol, recreational drugs, high caffeine intake).

Causes of Infertility

  • ovulatory defect,
  • tubal occlusion,
  • low sperm counts), and many

Factors lower the chance of pregnancy

  • older age,
  • lower ovarian reserve,
  • endometriosis

Factors can’t be altered

  • age and
  • ovarian reserve

Modifiable Factors:

  • body weight and
  • lifestyle habits

 

REFERENCES

SOURCE

http://Peter Kovacs. Food and Fertility: What Should Women Consume When Trying to Conceive? – Medscape – Dec 06, 2018.

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Omega-3 fats Supplements Effect on Cardiovascular Health: EPA and DHA has little or no effect on Mortality or Cardiovascular Health

Reporter: Aviva Lev-Ari, PhD, RN

 

Cochrane Database Syst Rev. 2018 Jul 18;7:CD003177. doi: 10.1002/14651858.CD003177.pub3. [Epub ahead of print]

Omega-3 fatty acids for the primary and secondary prevention of cardiovascular disease.

Abstract

BACKGROUND:

Researchers have suggested that omega-3 polyunsaturated fatty acids from oily fish (long-chain omega-3 (LCn3), including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)), as well as from plants (alpha-linolenic acid (ALA)) benefit cardiovascular health. Guidelines recommend increasing omega-3-rich foods, and sometimes supplementation, but recent trials have not confirmed this.

OBJECTIVES:

To assess effects of increased intake of fish- and plant-based omega-3 for all-cause mortality, cardiovascular (CVD) events, adiposity and lipids.

SEARCH METHODS:

We searched CENTRAL, MEDLINE and Embase to April 2017, plus ClinicalTrials.gov and World Health Organization International Clinical Trials Registry to September 2016, with no language restrictions. We handsearched systematic review references and bibliographies and contacted authors.

SELECTION CRITERIA:

We included randomised controlled trials (RCTs) that lasted at least 12 months and compared supplementation and/or advice to increase LCn3 or ALA intake versus usual or lower intake.

DATA COLLECTION AND ANALYSIS:

Two review authors independently assessed studies for inclusion, extracted data and assessed validity. We performed separate random-effects meta-analysis for ALA and LCn3 interventions, and assessed dose-response relationships through meta-regression.

MAIN RESULTS:

We included 79 RCTs (112,059 participants) in this review update and found that 25 were at low summary risk of bias. Trials were of 12 to 72 months’ duration and included adults at varying cardiovascular risk, mainly in high-income countries. Most studies assessed LCn3 supplementation with capsules, but some used LCn3- or ALA-rich or enriched foods or dietary advice compared to placebo or usual diet.Meta-analysis and sensitivity analyses suggested little or no effect of increasing LCn3 on all-cause mortality (RR 0.98, 95% CI 0.90 to 1.03, 92,653 participants; 8189 deaths in 39 trials, high-quality evidence), cardiovascular mortality (RR 0.95, 95% CI 0.87 to 1.03, 67,772 participants; 4544 CVD deaths in 25 RCTs), cardiovascular events (RR 0.99, 95% CI 0.94 to 1.04, 90,378 participants; 14,737 people experienced events in 38 trials, high-quality evidence), coronary heart disease (CHD) mortality (RR 0.93, 95% CI 0.79 to 1.09, 73,491 participants; 1596 CHD deaths in 21 RCTs), stroke (RR 1.06, 95% CI 0.96 to 1.16, 89,358 participants; 1822 strokes in 28 trials) or arrhythmia (RR 0.97, 95% CI 0.90 to 1.05, 53,796 participants; 3788 people experienced arrhythmia in 28 RCTs). There was a suggestion that LCn3 reduced CHD events (RR 0.93, 95% CI 0.88 to 0.97, 84,301 participants; 5469 people experienced CHD events in 28 RCTs); however, this was not maintained in sensitivity analyses – LCn3 probably makes little or no difference to CHD event risk. All evidence was of moderate GRADE quality, except as noted.Increasing ALA intake probably makes little or no difference to all-cause mortality (RR 1.01, 95% CI 0.84 to 1.20, 19,327 participants; 459 deaths, 5 RCTs),cardiovascular mortality (RR 0.96, 95% CI 0.74 to 1.25, 18,619 participants; 219 cardiovascular deaths, 4 RCTs), and it may make little or no difference to CHD events (RR 1.00, 95% CI 0.80 to 1.22, 19,061 participants, 397 CHD events, 4 RCTs, low-quality evidence). However, increased ALA may slightly reduce risk of cardiovascular events (from 4.8% to 4.7%, RR 0.95, 95% CI 0.83 to 1.07, 19,327 participants; 884 CVD events, 5 RCTs, low-quality evidence), and probably reduces risk of CHD mortality (1.1% to 1.0%, RR 0.95, 95% CI 0.72 to 1.26, 18,353 participants; 193 CHD deaths, 3 RCTs), and arrhythmia (3.3% to 2.6%, RR 0.79, 95% CI 0.57 to 1.10, 4,837 participants; 141 events, 1 RCT). Effects on stroke are unclear.Sensitivity analysis retaining only trials at low summary risk of bias moved effect sizes towards the null (RR 1.0) for all LCn3 primary outcomes except arrhythmias, but for most ALA outcomes, effect sizes moved to suggest protection. LCn3 funnel plots suggested that adding in missing studies/results would move effect sizes towards null for most primary outcomes. There were no dose or duration effects in subgrouping or meta-regression.There was no evidence that increasing LCn3 or ALA altered serious adverse events, adiposity or lipids, although LCn3 slightly reduced triglycerides and increased HDL. ALA probably reduces HDL (high- or moderate-quality evidence).

AUTHORS’ CONCLUSIONS:

This is the most extensive systematic assessment of effects of omega-3 fats on cardiovascular health to date. Moderate- and high-quality evidence suggests that increasing EPA and DHA has little or no effect on mortality or cardiovascular health (evidence mainly from supplement trials). Previous suggestions of benefits from EPA and DHA supplements appear to spring from trials with higher risk of bias. Low-quality evidence suggests ALA may slightly reduce CVD event risk, CHD mortality and arrhythmia.

PMID:
30019766
DOI:
10.1002/14651858.CD003177.pub3

SOURCE

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Reporter and Curator: Dr. Sudipta Saha, Ph.D.

 

A heart-healthy diet has been the basis of atherosclerotic cardiovascular disease (ASCVD) prevention and treatment for decades. The potential cardiovascular (CV) benefits of specific individual components of the “food-ome” (defined as the vast array of foods and their constituents) are still incompletely understood, and nutritional science continues to evolve.

 

The scientific evidence base in nutrition is still to be established properly. It is because of the complex interplay between nutrients and other healthy lifestyle behaviours associated with changes in dietary habits. However, several controversial dietary patterns, foods, and nutrients have received significant media exposure and are stuck by hype.

 

Decades of research have significantly advanced our understanding of the role of diet in the prevention and treatment of ASCVD. The totality of evidence includes randomized controlled trials (RCTs), cohort studies, case-control studies, and case series / reports as well as systematic reviews and meta-analyses. Although a robust body of evidence from RCTs testing nutritional hypotheses is available, it is not feasible to obtain meaningful RCT data for all diet and health relationships.

 

Studying preventive diet effects on ASCVD outcomes requires many years because atherosclerosis develops over decades and may be cost-prohibitive for RCTs. Most RCTs are of relatively short duration and have limited sample sizes. Dietary RCTs are also limited by frequent lack of blinding to the intervention and confounding resulting from imperfect diet control (replacing 1 nutrient or food with another affects other aspects of the diet).

 

In addition, some diet and health relationships cannot be ethically evaluated. For example, it would be unethical to study the effects of certain nutrients (e.g., sodium, trans fat) on cardiovascular disease (CVD) morbidity and mortality because they increase major risk factors for CVD. Epidemiological studies have suggested associations among diet, ASCVD risk factors, and ASCVD events. Prospective cohort studies yield the strongest observational evidence because the measurement of dietary exposure precedes the development of the disease.

 

However, limitations of prospective observational studies include: imprecise exposure quantification; co-linearity among dietary exposures (e.g., dietary fiber tracks with magnesium and B vitamins); consumer bias, whereby consumption of a food or food category may be associated with non-dietary practices that are difficult to control (e.g., stress, sleep quality); residual confounding (some non-dietary risk factors are not measured); and effect modification (the dietary exposure varies according to individual/genetic characteristics).

 

It is important to highlight that many healthy nutrition behaviours occur with other healthy lifestyle behaviours (regular physical activity, adequate sleep, no smoking, among others), which may further confound results. Case-control studies are inexpensive, relatively easy to do, and can provide important insight about an association between an exposure and an outcome. However, the major limitation is how the study population is selected or how retrospective data are collected.

 

In nutrition studies that involve keeping a food diary or collecting food frequency information (i.e., recall or record), accurate memory and recording of food and nutrient intake over prolonged periods can be problematic and subject to error, especially before the diagnosis of disease.

 

The advent of mobile technology and food diaries may provide opportunities to improve accuracy of recording dietary intake and may lead to more robust evidence. Finally, nutrition science has been further complicated by the influences of funding from the private sector, which may have an influence on nutrition policies and practices.

 

So, the future health of the global population largely depends on a shift to healthier dietary patterns. Green leafy vegetables and antioxidant suppliments have significant cardio-protective properties when consumed daily. Plant-based proteins are significantly more heart-healthy compared to animal proteins.

 

However, in the search for the perfect dietary pattern and foods that provide miraculous benefits, consumers are vulnerable to unsubstantiated health benefit claims. As clinicians, it is important to stay abreast of the current scientific evidence to provide meaningful and effective nutrition guidance to patients for ASCVD risk reduction.

 

Available evidence supports CV benefits of nuts, olive oil and other liquid vegetable oils, plant-based diets and plant-based proteins, green leafy vegetables, and antioxidant-rich foods. Although juicing may be of benefit for individuals who would otherwise not consume adequate amounts of fresh fruits and vegetables, caution must be exercised to avoid excessive calorie intake. Juicing of fruits / vegetables with pulp removal increases calorie intake. Portion control is necessary to avoid weight gain and thus cardiovascular health.

 

There is currently no evidence to supplement regular intake of antioxidant dietary supplements. Gluten is an issue for those with gluten-related disorders, and it is important to be mindful of this in routine clinical practice; however, there is no evidence for CV or weight loss benefits, apart from the potential caloric restriction associated with a gluten free diet.

 

References:

 

https://www.ncbi.nlm.nih.gov/pubmed/28254181

 

https://www.sciencedirect.com/science/article/pii/S0735109713060294?via%3Dihub

 

http://circ.ahajournals.org/content/119/8/1161

 

http://refhub.elsevier.com/S0735-1097(17)30036-0/sref6

 

https://www.scopus.com/record/display.uri?eid=2-s2.0-0031709841&origin=inward&txGid=af40773f7926694c7f319d91efdcd40c

 

https://www.magonlinelibrary.com/doi/10.12968/hosp.2000.61.4.1875

 

https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2548255

 

https://pharmaceuticalintelligence.com/2018/05/31/supplements-offer-little-cv-benefit-and-some-are-linked-to-harm-in-j-am-coll-cardiol/

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ADDRESS FOR CORRESPONDENCE: Dr. Andrew M. Freeman, Division of Cardiology, Department of Medicine, National Jewish Health, 1400 Jackson Street, J317, Denver, Colorado 80206. E-mail: andrew@docandrew.com.

Item Level of Evidence Available and Included in This Paper Recommendations for Patients Dietary pattern with added fats, fried food, eggs, organ and processed meats, and sugar-sweetened beverages (Southern diet pattern) Prospective studies Avoid Dietary cholesterol RCTs and prospective studies along with meta-analyses Limit Canola oil RCT meta-analyses show improvement in lipids but no prospective studies or RCTs for CVD outcomes In moderation Coconut oil RCT meta-analyses and observational studies on adverse lipid effects. No prospective studies or RCTs for CVD outcomes Avoid Sunflower oil No prospective studies or RCTs for CVD outcomes In moderation Olive oil RCTs supporting improved CVD outcomes In moderation Palm oil RCTs and observation studies showing worsened CVD outcomes Avoid Antioxidant-rich fruits and vegetables RCTs and observational studies showing improved CVD outcomes and improvements in blood lipids Frequent Antioxidant supplements RCTs and prospective and observational studies show potential harm Avoid Nuts RCT and large prospective and meta-analysis studies showing improved CVD outcomes In moderation Green leafy vegetables Large meta-analyses and variably sized observational studies as well as a large prospective study Frequent Protein from plant sources Large observational and prospective studies Frequent Gluten-containing foods Observational studies and RCTs Avoid if sensitive or allergic
CENTRAL ILLUSTRATION Evidence for Cardiovascular Health Impact of Foods Reviewed Summary of heart-harmful and heart-healthy foods/diets Coconut oil and palm oil are high in saturated fatty acids and raise cholesterol Extra-virgin olive oil reduces some CVD outcomes when Blueberries and strawberries (>3 servings/week) induce protective antioxidants 30 g serving of nuts/day. Portion control is necessary to avoid weight gain.† Green leafy vegetables have significant cardioprotective properties when consumed daily Plant-based proteins are significantly more heart-healthy compared to animal proteins Eggs have a serum cholesterol-raising effect Juicing of fruits/vegetables with pulp removal increases Southern diets caloric concentration* (added fats and oils, fried foods, eggs, organ and processed meats, sugar-sweetened drinks) High-dose antioxidant supplements Juicing of fruits/vegetables without pulp removal* Gluten-containing foods (for people without gluten-related disease) Evidence of harm; limit or avoid Evidence of benefit; recommended Inconclusive evidence; for harm or benefit Sunflower oil and other liquid vegetable oils consumed in moderate quantities Freeman, A.M. et al. J Am Coll Cardiol. 2017;69(9):1172–87. This figure summarizes the foods discussed in this paper that should be consumed often, and others that should be avoided from a cardiovascular health perspective. *It is important to note that juicing becomes less of a benefit if calorie intake increases because of caloric concentration with pulp removal. †Moderate quantities are required to prevent caloric excess.
Source: J Am Coll Cardiol
Curated by: Emily Willingham, PhD
May 30, 2018

Takeaway

  • Antioxidants and niacin are tied to increased all-cause mortality, and other popular supplements offer little detectable cardiovascular (CV) benefit.
  • Folic acid and B6 and B12 might offer some stroke protection.

Why this matters

  • Supplements, including multivitamins, vitamins C and D, and calcium, remain hugely popular.
  • These authors evaluated supplement-related randomized controlled trials published before and since the US Preventive Services Task Force’s 2013 evidence review and 2014 recommendation statement.

Keyresults

  • 4 most common supplements (vitamins D and C, calcium, multivitamins) had no effect on CV outcomes, all-cause mortality.
  • With folic acid
    • Modest stroke reduction (2 studies: relative risk [RR], 0.80; P=.003).
    • CV disease reduction (5 studies: RR, 0.83; P=.002).
  • Other supplements
    • B-complex: reduced stroke risk, 9/12 trials (RR, 0.90; P=.04).
    • Niacin: taken with statin, tied to 10% increased all-cause mortality (P=.05).
    • Antioxidants: increased all-cause mortality, 21 trials (RR, 1.06; P=.05; without selenium: RR, 1.09 [95% CI, 1.04-1.13; P=.0002]).
    • No effect of vitamins A, B6, E, beta-carotene, minerals.

Study design

  • Meta-analysis, 179 randomized controlled trials (15 since 2013/2014).
  • Outcomes: all-cause/CV mortality, total CV disease risk/related outcomes.
  • Funding: Canada Research Chair Endorsement, others.

Limitations

  • No long-term cohort studies included.

  • Selected populations in clinical trials.

  • Supplement differences possible.

SOURCE

http://univadis.com/player/ykvkttzwr?m=1_20180531&partner=unl&rgid=5wrwznernxgefmacwqyebgmyb&ts=2018053100&o=tile_01_id

Other related articles in this Open Access Online Scientific Journal include the following: 

Nutrition: Articles of Note @PharmaceuticalIntelligence.com

Author and Curator: Larry H. Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/03/28/nutrition-articles-of-note-pharmaceuticalintelligence-com/

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“Minerals in Medicine” –  40 Minerals that are crucial to Human Health and Biomedicine: Exhibit by NIH Clinical Center and The Smithsonian Institution National Museum of Natural History

Reporter: Aviva Lev-Ari, PhD, RN

 

Friday, September 9, 2016

NIH Clinical Center and The Smithsonian Institution partner to launch Minerals in Medicine Exhibition

What

The National Institutes of Health Clinical Center, in partnership with The Smithsonian Institution National Museum of Natural History, will open a special exhibition of more than 40 minerals that are crucial to human health and biomedicine. “Minerals in Medicine” is designed to enthrall and enlighten NIH Clinical Center’s patients, their loved ones, and the NIH community. Media are invited into America’s Research Hospital, the NIH Clinical Center, to experience this unique exhibition during a ribbon cutting ceremony on Monday September 12 at 4pm.

Beyond taking in the minerals’ arresting beauty, spectators can learn about their important role in keeping the human body healthy, and in enabling the creation of life-saving medicines and cutting edge medical equipment that is used in the NIH Clinical Center and healthcare facilities worldwide. The exhibition, which is on an eighteen-month loan from the National Museum of Natural History, includes specimens that were handpicked from the museum’s vast collection by NIH physicians in partnership with Smithsonian Institution geologists. Some of the minerals on display were obtained regionally as they are part of the Maryland and Virginia landscape.

Who

  • John I. Gallin, M.D., Director of the NIH Clinical Center
  • Jeffrey E. Post, Ph.D., Smithsonian Institution National Museum of Natural History, Chair of the Department of Mineral Sciences and Curator of the National Gem and Mineral Collection

When

Monday, September 12, 2016, 4:00 – 5:00 p.m.

Where

NIH Clinical Center (Building 10), 10 Center Drive, Bethesda, MD, 20892; 1st Floor near Admissions

How

RSVP encouraged, but not required, to attend in person. NIH Visitors Map: http://www.ors.od.nih.gov/maps/Pages/NIH-Visitor-Map.aspx

About the NIH Clinical Center: The NIH Clinical Center is the clinical research hospital for the National Institutes of Health. Through clinical research, clinician-investigators translate laboratory discoveries into better treatments, therapies and interventions to improve the nation’s health. More information: http://clinicalcenter.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

SOURCE

https://www.nih.gov/news-events/news-releases/nih-clinical-center-smithsonian-institution-partner-launch-minerals-medicine-exhibition

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