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Effects of Dehydroepiandrosterone (DHEA) in Humans

This study has been completed.
Information provided by:
National Institute on Aging (NIA) Identifier:
First received: September 13, 2005
Last updated: August 21, 2008
Last verified: August 2008
The purpose of this study is to determine whether bringing back the DHEA levels of older persons to the young range produces beneficial effects.

Condition Intervention Phase
Drug: DHEA replacement
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Is DHEA Replacement Beneficial?

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • body composition (e.g. truncal fat and visceral fat), insulin resistance and serum triglycerides, muscle mass and strength

Secondary Outcome Measures:
  • bone mineral density, arterial-endothelium dependent vasodilatation, sense of well being, RMR (Resting Metabolic Rate), TEF (Thermal Effect of Food)

Enrollment: 142
Study Start Date: September 2002
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Detailed Description:

DHEA and DHEA sulfate (DHEAS) plasma concentrations peak at about 20 years of age and decline rapidly and markedly after age 25 yr. DHEA is a PPAR-alpha activator. PPAR-alpha plays major roles in regulating lipid metabolism and controlling inflammation. DHEA also appears to have anabolic effects on muscle and bone. The study is designed to determine the effects of 12 months of DHEA replacement in 65-75 year old women and men on (a) truncal and visceral fat, (b) insulin resistance and serum triglycerides, (c) muscle mass and strength, (d) bone mineral density, (e) chronic inflammation, (f) arterial-endothelium-dependent vasodilation, and (g) sense of well being.

The specific aims of this study are to test the hypotheses that 12 months of DHEA replacement will (a) Result in significant decreases in truncal and visceral fat by shifting metabolism to fat oxidation and increasing energy wastage; (b) Decrease insulin resistance and decrease serum triglycerides; (c) Increase muscle mass and strength, by decreasing catabolic stimuli and increasing anabolic stimuli; (d) Increase bone mineral density by increasing anabolic stimuli and decreasing catabolic stimuli; (e) Reduce chronic inflammation and decrease pro-inflammatory cytokine production by peripheral blood mononuclear cells; (f) Improve arterial endothelium dependent vasodilation; and (g) Improve general sense of well being.


Ages Eligible for Study:   65 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 65 to 75 years old
  • Physically healthy
  • Non-smoker
  • On stable medications for at least 6 months
  • Stable body weight for the past year

Exclusion Criteria:

  • Serious active medical problems
  • Hormone therapy
  • Abnormal PSA (prostate specific antigen) in men
  Contacts and Locations
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Please refer to this study by its identifier: NCT00182975

United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63131
Sponsors and Collaborators
National Institute on Aging (NIA)
Principal Investigator: John O. Holloszy, MD Washington University School of Medicine
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00182975     History of Changes
Other Study ID Numbers: AG0047  R01AG020076 
Study First Received: September 13, 2005
Last Updated: August 21, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Metabolic syndrome

Additional relevant MeSH terms:
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs processed this record on December 09, 2016