Effects of DHEA and Exercise in the Elderly

Healthy Volunteers Clinical Trial

Official title:

DHEA+Exercise-Effect on Sarcopenia and Osteopenia of Aging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00205686
• Other study ID #: K23RR016191
• Secondary ID: K23RR016191
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: January 4, 2006
• Start date: April 2001
• Est. completion date: September 2005

Study information

• Verified date: September 2005
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 78 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• DHEA

Behavioral:
• exercise

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	thigh muscle mass, muscle strength, intadominal fat, bone mineral density, markers of bone turnover, insulin sensitivity,
Secondary	quality of life, vascular reactivity, levels of hormones