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Completed

NCT Number: NCT01832584

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

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

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Sheba Medical Center

Tel Litwinsky, 52621, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RGC

Dietary Supplement

Other names: Red Grape Cell powder

Placebo

Dietary Supplement

Primary outcomes

  1. changes in aerobic fitness

    Time frame: baseline and 6 weeks

Secondary outcomes

  1. Changes in Body Mass Index (BMI)

    Time frame: baseline and 6 weeks

  2. Changes in mood

    Time frame: baseline and 6 weeks

  3. Changes in body weight

    Time frame: baseline and 6 weeks

  4. Changes in body composition

    Time frame: baseline and 6 weeks

    changes in body fat percentage

Other outcomes

  1. Number of adverse events

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Fruitura Bioscience Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 16, 2013
Registry last updated
Jul 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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