Effect of Resvida, a Comparison With Calorie Restriction Regimen

Obesity Clinical Trial

— Resvida  

Official title:

Effect of Resvida(tm) Dietary Supplementation on Muscle Gene Expression: A Comparison With Calorie Restriction Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00823381
• Other study ID #: 2007-09-25-RESV
• Status: Completed
• Phase: N/A
• First received: January 13, 2009
• Last updated: December 9, 2013
• Start date: January 2009
• Est. completion date: December 2010

Study information

• Verified date: December 2013
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aging
• Diabetes
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity

Intervention

Dietary Supplement:
• resveratrol
one pill of resveratrol (Resvida™) 75 mg once a day with breakfast

Other:
• placebo
one placebo pill taken once a day with breakfast

Behavioral:
• Calorie Restriction
supervised calorie restriction diet: 30% reduction in caloric intake

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	DSM Nutritional Products, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	global skeletal muscle gene expression profile		three months	No
Secondary	insulin sensitivity		three months	No
Secondary	intrahepatic triglyceride content, body composition		three months	No
Secondary	blood lipid levels, markers of inflammation and plasma hormones		three months	No
Secondary	safety and tolerability		three months	Yes