Clinical trial NCT00434915: Does DHEA Enhance the Effects of Exercise in Postmenopausal Women?
Official title: Does DHEA Enhance the Effects of Exercise in Postmenopausal Women?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: National Institutes of Health (NIH)
First posted: 2007-02-14
Enrollment: 32
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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


Eligibility 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

Primary outcomes:
measure: physical performance (VO2 peak, muscle strength as measured by chest press, double knee extension, and isokinetic knee extension
measure: quality of life
measure: glucose and insulin metabolism
measure: muscle protein synthesis
measure: body composition
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: K. Sreekumaran Nair, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: