Clinical trial NCT01832584: Effect of Red Grape Cells (RGC) Powder Consumption on Measures of Aerobic Fitness and Mood
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Red Grapes
polyphenols
cyclists
resveratrol
aerobic fitness
trained
Lead sponsor: Fruitura Bioscience Ltd.
Sponsor class: INDUSTRY
First posted: 2013-04-16
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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


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

Primary outcomes:
measure: changes in aerobic fitness
timeFrame: baseline and 6 weeks
Secondary outcomes:
measure: Changes in Body Mass Index (BMI)
timeFrame: baseline and 6 weeks
measure: Changes in mood
timeFrame: baseline and 6 weeks
measure: Changes in body weight
timeFrame: baseline and 6 weeks
measure: Changes in body composition
timeFrame: baseline and 6 weeks
Other outcomes:
measure: Number of adverse events
timeFrame: 6 weeks
Locations:
city: Tel-Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Gal Dubnov-Raz, M.D
role: PRINCIPAL_INVESTIGATOR
References: