Effects of DHEA and Exercise in the Elderly

Sponsor
Washington University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT00205686
Collaborator
(none)
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Study Details

Study Description

Brief Summary

DHEA or dehydroepiandrosterone is a naturally occurring hormone secreted by tghe adrenal galnds. The secretion of HDEA declines with aging. DHEA is considered a food supplement and it is not regulated by the FDA. The purpose of this research is to evaluate ceratin of the biological effects of a reaplcement dose of DHEA. As you get older, DHEA levels are lower than you were younger. The replamcent dose is the dose of DHEA that will raise DHEA levesl to the levels found in young people. Anotehr purpose is to determine whether DHEA enhances the adaptations to an exercise training program.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

DHEA declines dramatically with age. Low DHEA levels have been found to correlate with sarcopenia and osteopenia. It is, therefore, postulated that many physiologic changes of aging are secondary to the decline in DHEA. Thus, the objective of the proposed research is to evaluate the effect of DHEA replacement on age-related changes in body composition, muscle function and metabolism, and bone mass in healthy older adults. The specific aims are to evaluate the effects of DHEA replacement (50 mg/d) alone, or in combination with resistance exercise training on: a) lean body mass, intraabdominal fat and thigh muscle volume, and muscle protein synthesis rate b) bone mineral density (BMD) of the total body, lumbar spine, and hip and biochemical markers of bone turnover and c) insulin sensitivity. It is hypothesized that DHEA administration will have additive or synergistic effects with exercise. Healthy but sedentary subjects , aged 65-78 years old, will be randomized to receive either DHEA, 50 mg/d, or placebo and to participate in either supervised or home exercise training programs. The supervised exercise program will consist of resistance training designed to increase muscle mass, strength, and bone mass, and decrease fat mass. The goal of this research is to provide information on the potential role of DHEA replacement therapy in maintaining the physical health and functional capacity of older people

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
DHEA+Exercise-Effect on Sarcopenia and Osteopenia of Aging
Study Start Date :
Apr 1, 2001
Study Completion Date :
Sep 1, 2005

Outcome Measures

Primary Outcome Measures

  1. thigh muscle mass, muscle strength, intadominal fat, bone mineral density, markers of bone turnover, insulin sensitivity, []

Secondary Outcome Measures

  1. quality of life, vascular reactivity, levels of hormones []

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 78 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 65 to 78 years old men and women
Exclusion Criteria:
  • hormone therapy, history of hormone-dependent neoplasia, PSA above 2.6 ng/mL, or active serious illness, contraindications to exercise, dementia

Contacts and Locations

Locations

Site City State Country Postal Code
1 Washington University School of Medicine St. Louis Missouri United States 63110

Sponsors and Collaborators

  • Washington University School of Medicine

Investigators

  • Principal Investigator: Dennis T Villareal, MD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00205686
Other Study ID Numbers:
  • K23RR016191
  • K23RR016191
First Posted:
Sep 20, 2005
Last Update Posted:
Jan 6, 2006
Last Verified:
Sep 1, 2005

Study Results

No Results Posted as of Jan 6, 2006