Effects of a Dietary Supplement on Lipoprotein Lipids and Inflammatory Markers

Completed · Not applicable

Conditions studied: Healthy Volunteers

In brief

The goal of this study is to assess the effects of a dietary supplement on fasting lipoprotein lipids and a marker of inflammation in men and women with levels of low-density lipoprotein cholesterol above desirable levels.

Key facts

Study ID

NCT03118583

Run by

Midwest Center for Metabolic and Cardiovascular Research

People needed

12

Starts

2017-03-15

Expected to finish

2018-01-31

Last updated by the study team

2018-05-15

Who can join

Age: 25 and older, up to 69. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Body mass index 18.5-34.9 kg/m2
• Judged to be in good health on basis of medical history and screening laboratory tests
• Fasting LDL-C ≥115 mg/dL and <190 mg/dL

You may not qualify if…

• Abnormal laboratory test results of clinical significance (e.g., TG ≥400 mg/dL, blood glucose ≥126 mg/dL, fasting creatinine ≥1.5 mg/dL, alanine aminotransferase or aspartate aminotransferase ≥1.5X the upper limit of normal)
• Atherosclerotic cardiovascular disease or other evidence of atherosclerotic cardiovascular disease (myocardial infarction or other acute coronary syndrome, coronary or other revascularization procedure, transient ischemic attack, ischemic stroke, atherosclerotic peripheral arterial disease or other documented atherosclerotic diseases)
• Recent major trauma or surgical event
• History or presence of clinically important pulmonary, endocrine, hepatic, renal, hematologic, immunologic, dermatologic, neurologic, psychiatric, or biliary disorders
• History or current gastrointestinal disorder with the potential to disrupt normal digestion and absorption
• Known allergy, sensitivity, or intolerance to any ingredients in the study product
• Uncontrolled hypertension
• Recent history of cancer (except non-melanoma skin cancer)
• Recent weight change ≥4.5 kg
• History of diagnosed eating disorder
• Extreme dietary habits
• Current or recent history of, or strong potential for, drug or alcohol abuse
• Recent use of medications intended to alter the lipid profile, (e.g., statins, bile acid sequestrants, cholesterol absorption inhibitor, fibrates, niacin [drug form] or omega-3 fatty acid drugs), weight-loss drugs or programs, systemic corticosteroids, anticoagulants, or unstable use of any antihypertensive medication
• Recent use of foods or dietary supplements with potential to influence lipid metabolism (e.g., omega-3 fatty acid supplements or fortified foods, sterol/stanol products, red rice yeast supplements, garlic supplements, soy isoflavone supplements, niacin or its analogues at doses >400 mg/d) and viscous dietary fiber supplements (e.g., psyllium, beta-glucan, methylceullylose and/or carrageenan)
• Recent use of antibiotics
• Pregnant, planning to be pregnant during the study period or lactating females or women of childbearing potential unwilling to commit to use of a medically approved form of contraception

Where it is running

• MB Clinical Research — Boca Raton, Florida, United States

Full record on ClinicalTrials.gov

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