Muscadine Grape Seed Supplementation and Vascular Function

NCT01011517 | Completed

• 1 other identifier: IRB00002611
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dietary Supplements

Keywords

muscadine grapes; endothelial function

Outcome Measures

Primary Outcomes (1)

• Brachial Artery Flow mediated dilation

  1 month

Secondary Outcomes (1)

• Plasma markers of inflammation and anitoxidant capacity

  1 month

Study Arms (2)

grape seed supplement

EXPERIMENTAL

Nature's Pearl 650 mg, two capsules daily

Dietary Supplement: Muscadine grape seed supplement

placebo

PLACEBO COMPARATOR

placebo

Dietary Supplement: Muscadine grape seed supplement

Interventions

Muscadine grape seed supplement DIETARY_SUPPLEMENT

Nature's Pearl 650 mg, two capsules daily

Also known as: Nature's Pearl 650 mg, two capsules daily

grape seed supplement; placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Study Officials

• David Herrington, MD, MHS

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2009
• First Posted: November 11, 2009
• Study Start: June 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: September 1, 2008
• Last Updated: August 9, 2018

Record last verified: 2018-08

Locations

US (1)