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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: RGC; Dietary Supplement: Placebo

• Registration Number: NCT01832584
• Lead Sponsor: Fruitura Bioscience Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-11
• Study First Submitted QC: 2013-04-12
• Study First Posted: 2013-04-16
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-13
• Last Update Posted: 2014-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RGC1	RGC	200 mg of Red Grape Cell (RGC) powder; daily oral dose
Placebo	Placebo	1000 mg placebo to Red Grape Cell (RGC) powder; daily oral dose
RGC2	RGC	1000 mg of Red Grape Cell (RGC) powder; daily oral dose

Primary Outcome Measures

Name	Time	Method
changes in aerobic fitness	baseline and 6 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in body weight	baseline and 6 weeks
Changes in Body Mass Index (BMI)	baseline and 6 weeks
Changes in mood	baseline and 6 weeks
Changes in body composition	baseline and 6 weeks	changes in body fat percentage

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Tel-Hashomer, Israel