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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: RGC

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel-Hashomer, Israel, 52621
    • Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RGC1; 200 mg of Red Grape Cell (RGC) powder; daily oral dose	Dietary supplement: RGC; Other Names: Red Grape Cell powder
Experimental: RGC2; 1000 mg of Red Grape Cell (RGC) powder; daily oral dose	Dietary supplement: RGC; Other Names: Red Grape Cell powder
Placebo Comparator: Placebo; 1000 mg placebo to Red Grape Cell (RGC) powder; daily oral dose	Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Time Frame
Number of adverse events	6 weeks

Collaborators and Investigators

• Sponsor: Fruitura Bioscience Ltd.
• Investigators: Principal Investigator: Gal Dubnov-Raz, M.D, Sheba Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: April 11, 2013
• First Submitted That Met QC Criteria: April 12, 2013
• First Posted (Estimate): April 16, 2013

Study Record Updates

• Last Update Posted (Estimate): July 15, 2014
• Last Update Submitted That Met QC Criteria: July 13, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: polyphenols; resveratrol; aerobic fitness; cyclists; Red Grapes; trained
• Other Study ID Numbers: RGC-04