The Dehydroepiandrosterone And WellNess (DAWN) study: research design and methods

Area of Science:

• Endocrinology
• Gerontology
• Pharmacology

Background:

• Adrenal androgens dehydroepiandrosterone (DHEA) and DHEA-sulfate (DHEAS) decline with age, coinciding with age-related diseases.
• Epidemiological and animal studies suggest DHEA(S) possesses cardioprotective, antiobesity, antidiabetic, and immune-enhancing properties.
• Restoring DHEA levels to those of young adults may mitigate age-related conditions.

Purpose of the Study:

• To evaluate the acceptability, benefits, and adverse effects of one-year oral DHEA replacement therapy.
• To assess DHEA's impact on bone health, body composition, muscle strength, immune function, and cardiovascular risk factors in healthy older adults.
• To examine potential gender-specific effects and the influence of age and baseline hormone levels on outcomes.

Main Methods:

• A double-blind, placebo-controlled randomized trial involving 110 men and 115 women aged 55-85.
• Participants received 50 mg of oral DHEA daily for one year.
• Comprehensive assessments included biological markers, body composition, strength, immune function, cardiovascular risk, mood, cognition, sexuality, and adverse events.

Main Results:

• The study aimed to examine a wide range of biological and functional outcomes.
• Potential mechanisms of DHEA action, such as biotransformation and effects on IGF-I and cytokines, were to be evaluated.
• The influence of gender, age, and baseline DHEA levels on outcomes was a key focus.

Conclusions:

• This study provides a robust design to investigate the comprehensive health benefits and safety of DHEA replacement in aging.
• It allows for the examination of DHEA's influence across diverse physiological systems and its interaction with demographic factors.
• The findings will contribute to understanding DHEA's potential role in managing age-related decline and disease.