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Effects of Dehydroepiandrosterone (DHEA) in Humans

Is DHEA Replacement Beneficial?

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00182975
Enrollment
142
Registered
2005-09-16
Start date
2002-09-30
Completion date
2007-09-30
Last updated
2008-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging

Keywords

Metabolic syndrome

Brief summary

The purpose of this study is to determine whether bringing back the DHEA levels of older persons to the young range produces beneficial effects.

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.

Interventions

Sponsors

National Institute on Aging (NIA)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
65 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frame
body composition (e.g. truncal fat and visceral fat), insulin resistance and serum triglycerides, muscle mass and strength

Secondary

MeasureTime frame
bone mineral density, arterial-endothelium dependent vasodilatation, sense of well being, RMR (Resting Metabolic Rate), TEF (Thermal Effect of Food)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026