Effect of Resvida, a Comparison With Calorie Restriction Regimen
NCT ID: NCT00823381
Last Updated: 2013-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
58 participants
INTERVENTIONAL
2009-01-31
2010-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Resveratrol is found in grape skin, wine, peanuts, and mulberries and is thought to have health benefits such as improving fat metabolism, insulin action, and possibly extending lifespan. Resvida™ is the name for the dietary supplement containing the natural antioxidant "resveratrol". Resvida™ will be supplied by DSM Nutritional Products, Ltd.
Resvida™ is considered a dietary supplement, and therefore it is not an approved drug by the Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug Administration does not strictly regulate herbs and dietary supplements. The makers of Resvida™ make no claim that this supplement is meant to treat any ailment.
Calorie restriction (CR) is a low calorie diet (about 30% fewer calories than the American Dietetic Association (ADA) recommends). Calorie restriction has also been linked to health benefits (enhanced cardiovascular and metabolic health) and an extended lifespan.
This study is designed to compare the health benefits of both resveratrol and CR and to determine if resveratrol mimics some of the health benefits shown with CR.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Resveratrol
resveratrol
one pill of resveratrol (Resvida™) 75 mg once a day with breakfast
Placebo
placebo
one placebo pill taken once a day with breakfast
Calorie Restriction
Calorie Restriction
supervised calorie restriction diet: 30% reduction in caloric intake
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
resveratrol
one pill of resveratrol (Resvida™) 75 mg once a day with breakfast
placebo
one placebo pill taken once a day with breakfast
Calorie Restriction
supervised calorie restriction diet: 30% reduction in caloric intake
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Caucasian
* Weight (defined as BMI): ≥ 20kg/m2 and \< 30 kg/m2.
* Subjects willing and able to give written informed consent and to understand, to participate and to comply with the study requirements with specific agreement to a measurement of global gene expression profiles
* Subjects with the ability to comprehend and complete forms in English
* Subjects who are likely to comply with study procedures
* Subjects who are willing to be assigned to the Resveratrol or CR or Placebo intervention
Exclusion Criteria
* History of major abdominal, thoracic or non-peripheral vascular surgery within one year prior to the randomization date
* Subjects with any allergic reaction or sensitivity to grape products or any component of the test article
* Subjects who are allergic to lidocaine
* Subjects currently on a low-calorie diet, a weight control or maintenance program, or those who practice a vegetarian or vegan diet
* Subjects who engage in programmed exercise \> 2 hours total per week
* Subjects who are smoking or stopped smoking within the past 6 months
* Subjects who have lost or gained \>5 kg over the past six months
* Subjects on any other clinical trial or experimental treatment within the past 3 months
* Intake of dietary supplements except vitamins and minerals
* Unwilling to restrict high resveratrol-containing foods
* Current alcohol consumption \>20 grams/day
* Current use of the following medications: weight loss medications (prescription or over-the-counter), beta-blockers, steroids, anticoagulants, any other medications that, in the opinion of the investigator, may compromise the validity or safety of the study.
35 Years
70 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
DSM Nutritional Products, Inc.
INDUSTRY
Washington University School of Medicine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Samuel Klein, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Washington University School of Medicine
St Louis, Missouri, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2007-09-25-RESV
Identifier Type: -
Identifier Source: org_study_id