Effect of Resvida, a Comparison With Calorie Restriction Regimen

NCT00823381 | Completed DMC

• 1 other identifier: 2007-09-25-RESV
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effects of the antioxidant "resveratrol" to a diet intervention (Calorie Restriction) to determine how each of them affects the following: gene expression profile, cholesterol (lipids), how well the hormone insulin works to control your blood sugar, and other blood and tissue markers of metabolic and cardiovascular health. 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.

Conditions

Obesity; Metabolic Syndrome; Diabetes; Aging

Keywords

obesity; metabolic syndrome; diabetes; aging; calorie restriction; resveratrol; antioxidant

Outcome Measures

Primary Outcomes (1)

• global skeletal muscle gene expression profile

  three months

Secondary Outcomes (4)

• insulin sensitivity

  three months

• intrahepatic triglyceride content, body composition

  three months

• blood lipid levels, markers of inflammation and plasma hormones

  three months

• safety and tolerability

  three months

Study Arms (3)

Resveratrol

EXPERIMENTAL

Dietary Supplement: resveratrol

Placebo

PLACEBO COMPARATOR

Other: placebo

Calorie Restriction

ACTIVE COMPARATOR

Behavioral: Calorie Restriction

Interventions

resveratrol DIETARY_SUPPLEMENT

one pill of resveratrol (Resvida™) 75 mg once a day with breakfast

Also known as: Resvida™

Resveratrol

placebo OTHER

one placebo pill taken once a day with breakfast

Placebo

Calorie Restriction BEHAVIORAL

supervised calorie restriction diet: 30% reduction in caloric intake

Calorie Restriction

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post-menopausal females (at least 1 year since last spontaneous menstrual bleeding)
• 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

You may not qualify if:

• History of serious or unstable medical or psychiatric disorders (e.g. diabetes, metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, immune, hepatic, renal, urologic, musculoskeletal, or cancer) that, in the opinion of the investigator, would make the candidate ineligible for the study.
• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• DSM Nutritional Products, Inc.: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Obesity; Metabolic Syndrome; Diabetes Mellitus

Interventions

Resveratrol; Caloric Restriction

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols; Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Samuel Klein, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2009
• First Posted: January 15, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 10, 2013

Record last verified: 2013-12

Locations

US (1)