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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01832584
Enrollment
45
Registered
2013-04-16
Start date
2013-04-30
Completion date
2013-09-30
Last updated
2014-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Red Grapes, polyphenols, cyclists, resveratrol, aerobic fitness, trained

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

Interventions

DIETARY_SUPPLEMENTRGC
DIETARY_SUPPLEMENTPlacebo

Sponsors

Fruitura Bioscience Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
changes in aerobic fitnessbaseline and 6 weeks

Secondary

MeasureTime frameDescription
Changes in moodbaseline and 6 weeks
Changes in Body Mass Index (BMI)baseline and 6 weeks
Changes in body weightbaseline and 6 weeks
Changes in body compositionbaseline and 6 weekschanges in body fat percentage

Other

MeasureTime frame
Number of adverse events6 weeks

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026