Industry, take note! Dietary supplements of all stripes (herbal, botanical, vitamins, minerals, marine-based, and others) are the subjects of numerous research studies and clinical trials this year. The National Institutes of Health (NIH) and its various branches are sponsoring studies of niacin, tart cherry and aronia berry, resveratrol, and vitamin E, among many, many others. The Global Organization for EPA and DHA Omega-3s (GOED; Salt Lake City) has on its radar three omega-3 fish-oil studies in particular whose results could have a major impact on the fortunes of its members.
Ahead, we outline some of the more interesting NIH dietary-supplement studies—most of which target cardiovascular health—and briefly summarize the omega-3 research noted by GOED’s leadership.
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The NIH’s National Heart, Lung and Blood Institute (NHLBI) is sponsoring a clinical research study of niacin’s positive effects on human cardiovascular health. (Niacin is found naturally in such foods as fish, meat, fruits, and vegetables. It is, of course, also available as a supplement.)
The researchers are hoping to better understand how niacin supplementation benefits cholesterol levels, fat metabolism, and vascular health in adults aged 18–99 with fasting good cholesterol (HDL-C) below 60 mg/dL.
Eligible participants will receive a two-week supply of niacin. They will take two tablets daily for one week, then four daily thereafter.
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Tart Cherry and Aronia Berry
In a study sponsored by the National Institute of Nursing Research (NINR), researchers will observe the effects of tart cherry and aronia berry supplementation on endothelial function and cardiovascular measures in healthy older adults (ages 55–75). Specific cardiovascular markers under examination include inflammation, oxidation, and cholesterol.
Study subjects will include men and women. For three weeks each, participants will take aronia berry extract capsules, tart cherry extract capsules, placebo capsules, and no capsules. They will report for a study visit every three weeks.
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The National Institute on Aging (NIA) is studying the hotly contested red-grape compound, resveratrol, in a study whose objective is to determine resveratrol’s effects on heart and blood-vessel health in older, overweight persons, and at what dosage.
Healthy overweight, nonsmoking older adults (aged 50–100 years) will participate in a screening visit and four study visits. Some of the study visits will involve overnight inpatient stays. Participants will be separated into three groups, two of which will take different dose levels of resveratrol. The third group will take a placebo.
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A complex, three-armed study will look at vitamin E pharmacokinetics and biomarkers in women, a population for whom vitamin E has been historically understudied.
The goal of this study, which is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), is threefold: 1) to determine the amount of fat required to obtain the best vitamin E absorption from a meal, 2) to determine the amount (i.e., best dose) of vitamin E that must be consumed before it can be measured in the blood, and 3) to examine how vitamin E and vitamin C work together in the body, in conjunction with diet and vitamin supplements.
This study is recruiting women only, ages 18–40. It will consist of five one-month-long studies.
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Omega-3 Fatty Acids
GOED is “eagerly anticipating” three large, ongoing omega-3 clinical studies with cardiovascular outcomes, says Harry Rice, vice president of scientific and regulatory affairs. None is due to be published this year, but it is “possible, albeit unlikely, that preliminary results could be presented at a scientific meeting,” Rice shares.
The first is VITAL-Bone Health, which involves two ancillary studies evaluating the effects of vitamin D and/or omega-3 fatty acid supplements on incident fractures and bone-health outcomes in the Vitamin D and Omega-3 Trial (VITAL). Results from these studies, sponsored by Brigham and Women’s Hospital (Boston) will, ideally, clarify the relationship between supplemental vitamin D and/or omega-3 fatty acids on bone health, and inform clinical care and public-health guidelines on supplementing with vitamin D for the prevention of fractures in women and men.
The second study is titled “Outcomes Study to Assess Statin Residual Risk Reduction With Epanova in High CV Risk Patients With Hypertriglyceridemia (STRENGTH).” Sponsored by pharmaceutical firm AstraZeneca (which sells omega-3 drug Epanova), the study will include eligible men or women considered to be at high risk for atherosclerotic cardiovascular disease.
Amarin Pharma’s REDUCE-IT study is the third that is eagerly anticipated by GOED, with the sponsoring company expecting to publish results in 2018. The purpose of this large study, according to information on ClinicalTrial.gov, is to evaluate whether the high-concentrate EPA drug AMR101, combined with a statin therapy, “will be superior to the statin therapy alone when used as a prevention in reducing long-term cardiovascular events in high-risk patients with mixed dyslipidemia.”
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