Effects of DHEA and Exercise in the Elderly
January 4, 2006 updated by: Washington University School of Medicine
DHEA+Exercise-Effect on Sarcopenia and Osteopenia of Aging
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment
64
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Missouri
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St. Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 78 years (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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thigh muscle mass, muscle strength, intadominal fat, bone mineral density, markers of bone turnover, insulin sensitivity,
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Secondary Outcome Measures
Outcome Measure |
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quality of life, vascular reactivity, levels of hormones
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dennis T Villareal, MD, Washington University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Villareal DT, Holloszy JO, Kohrt WM. Effects of DHEA replacement on bone mineral density and body composition in elderly women and men. Clin Endocrinol (Oxf). 2000 Nov;53(5):561-8. doi: 10.1046/j.1365-2265.2000.01131.x.
- Villareal DT, Holloszy JO. Effect of DHEA on abdominal fat and insulin action in elderly women and men: a randomized controlled trial. JAMA. 2004 Nov 10;292(18):2243-8. doi: 10.1001/jama.292.18.2243.
- Villareal DT. Effects of dehydroepiandrosterone on bone mineral density: what implications for therapy? Treat Endocrinol. 2002;1(6):349-57. doi: 10.2165/00024677-200201060-00001.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2001
Study Completion
September 1, 2005
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
January 6, 2006
Last Update Submitted That Met QC Criteria
January 4, 2006
Last Verified
September 1, 2005
More Information
Terms related to this study
Other Study ID Numbers
- K23RR016191 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.