Completed

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

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What is being tested

RGC

+ RGC

+ Placebo

Dietary Supplement
Who is being recruted

From 18 to 65 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Placebo-Controlled
Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorFruitura Bioscience Ltd.
Last updated: July 15, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

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

NCT01832584
Principal SponsorFruitura Bioscience Ltd.
Last updated: July 15, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

45 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
Active in cycling training group
Age 18 - 65 years, men only
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
Willingness to avoid regular use of NSAIDS (Advil, Nurofen, etc.) and aspirin for the entire study period
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9 exclusion criteria prevent from participating
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 gastrointestinal surgery other than appendectomy or herniotomy
Any known chronic medical condition (will be determined by the principal investigator)
Current use of over the counter or prescription weight loss medication
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
200 mg of Red Grape Cell (RGC) powder; daily oral dose

Group II

Experimental
1000 mg of Red Grape Cell (RGC) powder; daily oral dose

Group III

Placebo
1000 mg placebo to Red Grape Cell (RGC) powder; daily oral dose

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Sheba Medical Center

Tel Litwinsky, IsraelOpen Sheba Medical Center in Google Maps
CompletedOne Study Center