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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01832584
• Other study ID #: RGC-04
• Status: Completed
• Phase: N/A
• First received: April 11, 2013
• Last updated: July 13, 2014
• Start date: April 2013
• Est. completion date: September 2013

Study information

• Verified date: July 2014
• Source: Fruitura Bioscience Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• RGC

• Placebo

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel-Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Fruitura Bioscience Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of adverse events		6 weeks	Yes
Primary	changes in aerobic fitness		baseline and 6 weeks	No
Secondary	Changes in Body Mass Index (BMI)		baseline and 6 weeks	No
Secondary	Changes in mood		baseline and 6 weeks	No
Secondary	Changes in body weight		baseline and 6 weeks	No
Secondary	Changes in body composition	changes in body fat percentage	baseline and 6 weeks	No