Effect of Red Grape Cells (RGC) Powder Consumption on Measures of Aerobic Fitness and Mood

Study Overview
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Brief Summary
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This is a 3-arm double blind placebo controlled study to investigate the effect of Red Grape Cell (RGC) powder containing all the matrix of polyphenols that can be found in red grapes. polyphenols have several beneficial effects on various body systems, are present in many edible foods, and are considered safe for human consumption by regulatory authorities. Animal and human studies suggest a potential for polyphenol-rich compounds in enhancing mitochondrial activity and exercise capacity. However, the effect of RGC on exercise performance in humans had not yet been tested. A special population where increasing performance is highly sought are competitive athletes. The aim of the current study is to investigate the effect of RGC on measures of aerobic fitness, body composition and mood in trained male cyclists

Official Title
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A Double-blind, Randomized, Placebo Controlled Study of the Effect of Red Grape Cells (RGC) Powder Consumption on Measures of Aerobic Fitness, Body Composition and Mood

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: RGC
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 - 65 years, men only Active in cycling training group Willingness to avoid regular use of NSAIDS (Advil, Nurofen, etc.) and aspirin for the entire study period Without a history or evidence of significant cardiovascular, hepatic, renal, respiratory, hematopoietic, gastrointestinal disease, endocrine, metabolic, psychiatric or psychological disorders; Willingness to avoid regular ingestion of any foods containing peanuts, bilberries, blueberries, cranberries, strawberries, raspberries, grapes, grape juice, cocoa powder, dark chocolate, red wine, over-the-counter medications, herbs, or supplements throughout the entire study, and to record and report any occasional consumption of such substances Exclusion Criteria: Any acute medical situation (e.g., acute infection, nausea and vomiting, diarrhea) 48 hours prior to initiation of the study, which is considered of significance by the principal investigator. Any known chronic medical condition (will be determined by the principal investigator) History or evidence of alcohol or drug abuse Any gastrointestinal surgery other than appendectomy or herniotomy; Current use of over the counter or prescription weight loss medication Current use or within the last 30 days, any cholesterol lowering medications (statins, fibrates, red yeast rice, niacin). Known allergy to casein and/or soy. Subjects who had participated in a drug trial 3 months before initiation of the study; Non-cooperative subjects or unwilling to sign an informed consent and participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RGC1<br>200 mg of Red Grape Cell (RGC) powder; daily oral dose | Dietary Supplement: RGC<br> <br> * Other names: Red Grape Cell powder;|
| Experimental: RGC2<br>1000 mg of Red Grape Cell (RGC) powder; daily oral dose | Dietary Supplement: RGC<br> <br> * Other names: Red Grape Cell powder;|
| Placebo Comparator: Placebo<br>1000 mg placebo to Red Grape Cell (RGC) powder; daily oral dose | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in aerobic fitness |  | baseline and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Body Mass Index (BMI) |  | baseline and 6 weeks | 
| Changes in mood |  | baseline and 6 weeks | 
| Changes in body weight |  | baseline and 6 weeks | 
| Changes in body composition | changes in body fat percentage | baseline and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Red Grapes, polyphenols, cyclists, resveratrol, aerobic fitness, trained