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

NCT ID: NCT01832584

Last Updated: 2014-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2013-09-30

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

RGC1

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

Group Type: EXPERIMENTAL

RGC

Intervention Type: DIETARY_SUPPLEMENT

RGC2

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

Group Type: EXPERIMENTAL

RGC

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Interventions

RGC

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Red Grape Cell powder

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fruitura Bioscience Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gal Dubnov-Raz, M.D

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

Sheba Medical Center

Tel Litwinsky, , Israel

Countries

Israel

Other Identifiers

RGC-04

Identifier Type: -

Identifier Source: org_study_id