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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy Men and Women

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Concord Grape extract 1
* Dietary Supplement: Concord Grape extract 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy men and women (pre and post-menopausal) aged 18-40 years Subjects are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study Are able to understand the nature of the study Able to give signed written informed consent Signed informed consent form Exclusion Criteria: Medical history of cardiovascular disease including coronary artery disease, cerebrovascular disease and peripheral artery disease Hypertensive, as defined as SBP superior or equal to 140 mmHg Obese participants, defined as BMI superior or equal to 30 kg/m2 Medical history of diabetes mellitus, metabolic syndrome, terminal renal failure or malignancies Abnormal heart rhythm (lower or higher than 60-100 bmp) Allergies to berries or other significant food allergy Subjects under medication that can affect the cardiovascular system or on vitamin/dietary supplements. Subjects who have lost more than 10% of their weight in the past 6 months or are currently in a diet Subjects who reported participant in another study within one month before the study start Subjects who smoke an irregular amount of cigarettes per day Pregnant women or planning to become pregnant in the next 6 months Any reason or condition that in the judgment of the clinical investigator(s) may put the subject at unacceptable risk or that may preclude the subject from understanding or complying with the study's requirements.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsules regimen (1g) | Dietary Supplement: Placebo<br>* Identical formulation as the treatment consisting of colored maltodextrin using artificial colors<br>|
| Active Comparator: Concord Grape Extract 1<br>1 g Concord Grape Extract in 2 capsules | Dietary Supplement: Concord Grape extract 1<br>* 1 g Concord Grape extract in 2 capsules<br>|
| Active Comparator: Concord Grape Extract 2<br>500 mg Concord Grape Extract in 2 capsules | Dietary Supplement: Concord Grape extract 2<br>* 500 mg Concord Grape extract in 2 capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in flow mediated dilation (FMD) of the brachial artery | Determine changes in flow mediated dilation (FMD) of the brachial artery after 12 week consumption of 500 mg or 1 g of Concord grape extract vs. Placebo | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in flow mediated dilation (FMD) of the brachial artery | Determine changes in flow mediated dilation (FMD) of the brachial artery between 2 hours post consumption of 500 mg or 1 g of Concord grape extract vs. Placebo on day 0 and 2 h post consumption of 500 mg and 1 g Concard Grape extract vs. Placebo on day 84 | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vascular function, endothelial function, polyphenols, Concord Grape