Status:
COMPLETED
Effect of Red Grape Cells (RGC) Powder Consumption on Measures of Aerobic Fitness and Mood
Lead Sponsor:
Fruitura Bioscience Ltd.
Conditions:
Healthy
Eligibility:
MALE
18-65 years
Phase:
NA
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 hav...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01832584
Start Date
April 1 2013
End Date
September 1 2013
Last Update
July 15 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sheba Medical Center
Tel Litwinsky, Israel, 52621