Clinical trial NCT00823381: Effect of Resvida, a Comparison With Calorie Restriction Regimen
Official title: Effect of Resvida(tm) Dietary Supplementation on Muscle Gene Expression: A Comparison With Calorie Restriction Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Metabolic Syndrome
Diabetes
Aging
Keywords: obesity
metabolic syndrome
diabetes
aging
calorie restriction
resveratrol
antioxidant
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: DSM Nutritional Products, Inc.
First posted: 2009-01-15
Enrollment: 58
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: global skeletal muscle gene expression profile
timeFrame: three months
Secondary outcomes:
measure: insulin sensitivity
timeFrame: three months
measure: intrahepatic triglyceride content, body composition
timeFrame: three months
measure: blood lipid levels, markers of inflammation and plasma hormones
timeFrame: three months
measure: safety and tolerability
timeFrame: three months
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Samuel Klein, M.D.
role: PRINCIPAL_INVESTIGATOR
References: