Effects of DHEA and Exercise in the Elderly

ID: NCT00205686

Status: Completed

Phase: Phase 3

Start Date: April 01, 2001

First Submitted: September 13, 2005

Last Updated: January 04, 2006

Results: N/A

Organization: Washington University School of Medicine

Sponsors & Collaborators: Washington University School of Medicine

Location: United States

Conditions: Healthy Volunteers

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Study Details
No Results Posted

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.

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

Condition or disease	Intervention/treatment	Phase
Healthy Volunteers	Drug: DHEA Other Names Behavioral: exercise Other Names	Phase 3

Tracking Information

First Submitted Date	September 13, 2005
Last Update Posted Date	January 04, 2006
Start Date	April 01, 2001
Completion Date	September 01, 2005
Primary Completion Date	N/A
Results First Submitted Date	N/A
Received Results Disposit Date	N/A

Current Primary Outcome Measures

thigh muscle mass, muscle strength, intadominal fat, bone mineral density, markers of bone turnover, insulin sensitivity,

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

quality of life, vascular reactivity, levels of hormones

Original Secondary Outcome Measures

Not Available

Study Design

Brief Title	Effects of DHEA and Exercise in the Elderly
Official Title	DHEA+Exercise-Effect on Sarcopenia and Osteopenia of Aging
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.
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
Study Phase	Phase 3
Estimated Enrollment	64
Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	Double
Primary Purpose	Treatment
Conditions	Healthy Volunteers
Target Follow-Up Duration	N/A
Biospecimen:	N/A
Sampling Method	N/A
Study Population	N/A
Intervention	Drug: DHEA Other Names Behavioral: exercise Other Names
Study Groups/Cohorts	Not Available
Study Arms	Not Available

Arm	Intervention/Treatment

Recruitment Information

Recruitment Status:	Completed
Enrollment	64
Completion Date	September 01, 2005
Eligibility Criteria:	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
Gender	All
Age	65 Years to 78 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Available
Listed Location Countries	United States

Administrative Information

NCT Number:	NCT00205686
Other Study ID Numbers	K23RR016191 K23RR016191
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement	Not Available
Responsible Party	N/A
Study Sponsor	Washington University School of Medicine
Collaborators	Not Available
Investigators	Principal Investigator Dennis T Villareal, MD Washington University School of Medicine

Publications

Villareal DT. Effects of dehydroepiandrosterone on bone mineral density: what implications for therapy? Treat Endocrinol. 2002;1(6):349-57. Review.

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.