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

NCT01832584 | Completed

• 1 other identifier: RGC-04
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• changes in aerobic fitness

  baseline and 6 weeks

Secondary Outcomes (4)

• Changes in Body Mass Index (BMI)

  baseline and 6 weeks

• Changes in mood

  baseline and 6 weeks

• Changes in body weight

  baseline and 6 weeks

• Changes in body composition

  baseline and 6 weeks

Other Outcomes (1)

• Number of adverse events

  6 weeks

Study Arms (3)

RGC1

EXPERIMENTAL

200 mg of Red Grape Cell (RGC) powder; daily oral dose

Dietary Supplement: RGC

RGC2

EXPERIMENTAL

1000 mg of Red Grape Cell (RGC) powder; daily oral dose

Dietary Supplement: RGC

Placebo

PLACEBO COMPARATOR

1000 mg placebo to Red Grape Cell (RGC) powder; daily oral dose

Dietary Supplement: Placebo

Interventions

RGC DIETARY_SUPPLEMENT

Also known as: Red Grape Cell powder

RGC1; RGC2

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fruitura Bioscience Ltd.: lead

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

Study Officials

• Gal Dubnov-Raz, M.D

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2013
• First Posted: April 16, 2013
• Study Start: April 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: July 15, 2014

Record last verified: 2014-07

Locations

IL (1)