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Does DHEA Enhance the Effects of Exercise in Postmenopausal Women?

This study has been completed.
Sponsor:
Collaborators:
National Institute on Aging (NIA)
National Institutes of Health (NIH)
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00434915
First received: February 12, 2007
Last updated: March 22, 2011
Last verified: March 2011
History of Changes
  Purpose

Dehydroepiandrostrone (DHEA) and its sulfated ester (DHEAS) are high circulating weak androgens which have been associated with conditions that accompany age-related decline such as sarcopenia, hyperinsulinemia, osteopenia, and cardiovascular disease. The decline in DHEA with age is particularly marked in postmenopausal women. Exercise has always been advocated in women; benefit has been demonstrated inmuscle, bone and lipid physiology, as well as perception of energy and sense of well-being. This study aims to explore the combined effect of both DHEA and exercise in postmenopausal women, age range 55-75 years old. Subjects will receive DHEA (50mg/day) or placebo for a 12-week period. At the beginning and conclusion of the study patients will undergo testing for muscle strength, body composition, VO2 max, insulin sensitivity, muscle biopsy with mitochondria enzyme measurements, and psychological analysis. Blood samples pre and post intervention will also be obtained and the level of selected anabolic markers, lipids, and androgenic and sex steroid levels will be assessed. For the twelve-week period, both placebo and DHEA treated participants will be involved in a resistance and aerobic exercise program coordinated through the GCRC and the Dan Abraham Healthy Living Center. Several correlations have been established with respect to exogenous DHEA administration in postmenopausal women. None have evaluated oral DHEA therapy in the setting resistance and aerobic exercise, key therapies advocated in postmenopausal women. As a plausible anabolic hormone DHEA is hypothesized to accentuate the effects of exercise as has been shown for testosterone. This study, as a randomized double-blind placebo controlled trial, will investigate the effects, if any, of a regimented exercise program and DHEA supplementation in postmenopausal women, specifically for evidence of enhancement of exercise effect by oral supplementation with DHEA in attenuating age-related decline


Condition Intervention
Aging
 Drug: DHEA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Does DHEA Enhance the Effects of Exercise in Postmenopausal Women?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • physical performance (VO2 peak, muscle strength as measured by chest press, double knee extension, and isokinetic knee extension
  • quality of life
  • glucose and insulin metabolism
  • muscle protein synthesis
  • body composition

Estimated Enrollment: 32
Study Start Date: April 2003
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects will be postmenopausal women between the ages of 60 and 75 years old.
  • Women with levels of DHEA less than 110 mg will be selected.

Exclusion Criteria:

  • Individuals with history or biochemical evidence of liver disease, cardiovascular disease (other than controlled hypertension); polycythemia, cerebrovascular disorders, or disorder of glucose metabolism with fasting hyperglycemia or hypoglycemia will be excluded.
  • Use of psycotropic drugs within six months prior to enrollment
  • History of severe depression or psychotic disorder
  • Professional athletes or BMI greater than 30kg/m2
  • Anyone who has been in a regular (greater than twice/weekly) exercise program for more than 2 months prior to the study
  • Severe rheumatologic condition with chronic pain not well controlled.
  • Use of DHEA, estrogen, progesterone, testosterone, corticosteroid products up to six months prior to study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00434915

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Institute on Aging (NIA)
National Institutes of Health (NIH)
Investigators
Principal Investigator: K. Sreekumaran Nair, M.D., Ph.D. Mayo Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00434915     History of Changes
Other Study ID Numbers: 2010-02, P01 AG-14383
Study First Received: February 12, 2007
Last Updated: March 22, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013