Muscadine Grape Seed Supplementation and Vascular Function

Completed · Not applicable · Has a placebo group

Conditions studied: Dietary Supplements

In brief

The investigators sought to evaluate the effect of muscadine grape seed supplementation on brachial diameter and flow-mediated vasodilator responses in subjects with, or at risk for cardiovascular disease. Methods: In a randomized, double-blind, placebo-controlled crossover trial, 50 adults (25 men, 25 women) with one or more cardiac risk factors were randomized to muscadine grape seed (MGS) supplement 1300mg daily vs.. placebo for 4 weeks each, with a 4-week washout between study periods. Resting diameter and endothelial function measured using brachial flow-mediated dilation (FMD) were determined at the beginning and end of each study period.

Key facts

Study ID

NCT01011517

Run by

Wake Forest University Health Sciences

People needed

50

Starts

2007-06-01

Expected to finish

2008-09-01

Last updated by the study team

2018-08-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• adult male and non-pregnant female outpatients, with
• hypertension (blood pressure ≥ 140/90 or current treatment for hypertension), or
• dyslipidemia (total cholesterol > 220 mg/dL + LDL cholesterol > 130 mg/dL, or current use of lipid-lowering medications), or
• controlled type 2 diabetes mellitus (glycated hemoglobin < 8.0 % with or without medication).

You may not qualify if…

• history of congestive heart failure (any classification)
• unstable angina or acute coronary syndrome within the last 30 days,
• uncontrolled hypertension (blood pressure ≥ 170/100 mm/Hg),
• type 1 diabetes mellitus,
• uncontrolled type 2 diabetes mellitus (HbA1C ≥ 8.0%),
• history of gastrointestinal disease or surgery affecting absorption,
• peripheral arterial disease,
• diagnosis of active cancer (excluding squamous cell or basal cell skin cancer),
• current use of long-acting nitrate compounds such as isosorbide dinitrate or nitroglycerin,
• recent change in any medications (last 30 days),
• active plan to change diet or exercise patterns,
• history of hypersensitivity to any compound in the intervention or placebo,
• history of intolerance to nitrates

Where it is running

• Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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