HealthyNCT01832584
Effect of Red Grape Cells (RGC) Powder Consumption on Measures of Aerobic Fitness and Mood
A study testing RGC in people with Healthy, run by Fruitura Bioscience Ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- RGC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2013to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- RGC, Placebo
- Keywords
- Red Grapes, polyphenols, cyclists, resveratrol, aerobic fitness, trained
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RGCDietary supplement
Also called Red Grape Cell powder
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| RGC1 | Experimental | 200 mg of Red Grape Cell (RGC) powder; daily oral dose Receives: Dietary Supplement: RGC |
| RGC2 | Experimental | 1000 mg of Red Grape Cell (RGC) powder; daily oral dose Receives: Dietary Supplement: RGC |
| Placebo | Placebo comparator | 1000 mg placebo to Red Grape Cell (RGC) powder; daily oral dose Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in aerobic fitness
Measured: baseline and 6 weeks
Secondary outcomes (4)
Changes in Body Mass Index (BMI)
Measured: baseline and 6 weeks
Changes in mood
Measured: baseline and 6 weeks
Changes in body weight
Measured: baseline and 6 weeks
Changes in body composition
changes in body fat percentage
Measured: baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fruitura Bioscience Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gal Dubnov-Raz, M.D, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832584
- Sponsor's protocol ID
- RGC-04
- Status last verified
- Jul 2014
- First submitted
- 11 Apr 2013
- Last updated
- 15 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01832584
- Acronym / sponsor ID
- RGC-04
- Conditions
- Healthy
- Keywords
- Red Grapes, polyphenols, cyclists, resveratrol, aerobic fitness, trained
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Fruitura Bioscience Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 16 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RGC1 | Experimental | Dietary Supplement: RGC200 mg of Red Grape Cell (RGC) powder; daily oral dose |
| RGC2 | Experimental | Dietary Supplement: RGC1000 mg of Red Grape Cell (RGC) powder; daily oral dose |
| Placebo | Placebo comparator | Dietary Supplement: Placebo1000 mg placebo to Red Grape Cell (RGC) powder; daily oral dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RGCAlso: Red Grape Cell powder | Dietary supplement | RGC1, RGC2 |
| Placebo | Dietary supplement | Placebo |
Primary outcome
changes in aerobic fitness
Time frame: baseline and 6 weeks
4 secondary outcomes
Changes in Body Mass Index (BMI)
Time frame: baseline and 6 weeks
Changes in mood
Time frame: baseline and 6 weeks
Changes in body weight
Time frame: baseline and 6 weeks
Changes in body composition
Time frame: baseline and 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gal Dubnov-Raz, M.D principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RGC in people with Healthy, run by Fruitura Bioscience Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in aerobic fitness (time frame: baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2014.