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Randomized, Double-blind, Controlled Study to Evaluate the Effect of Concord Grape Extract on Vascular Function in Healthy Men and Women

NCT03553225 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2019-07-09

No results posted yet for this study

Summary

Concord grape (Vitis Labrusca) is rich in polyphenols such as anthocyanins, flavanols, procyanidins and flavonols. Current reports investigating the effects of Concord grape (CG) consumption on cardiovascular disease (CVD) risk have provided mixed results. Studies were limited by small sample size or lacked a control arm. Moreover, subjects presented with CVD or CVD risk factors and thus to our knowledge, it remains unknown as to whether the consumption of Concord Grape (poly)phenols can maintain vascular function in healthy individuals. The aim of this study is therefore to examine both acute and chronic effects of Concord Grape on cardiovascular health by investigating whether daily consumption of Concord Grape Extract (CGE) for 12 weeks can affect biomarkers of CVD risk, including endothelial function, blood pressure and blood lipids, in young healthy men and women.

Conditions

  • Healthy Men and Women

Interventions

DIETARY_SUPPLEMENT

Placebo

Identical formulation as the treatment consisting of colored maltodextrin using artificial colors

DIETARY_SUPPLEMENT

Concord Grape extract 1

1 g Concord Grape extract in 2 capsules

DIETARY_SUPPLEMENT

Concord Grape extract 2

500 mg Concord Grape extract in 2 capsules

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-17
Primary Completion
2019-05-17
Completion
2019-05-17

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03553225 on ClinicalTrials.gov