AgingNCT00434915
Does DHEA Enhance the Effects of Exercise in Postmenopausal Women?
A study testing DHEA in people with Aging, run by Mayo Clinic at 1 site in United States.
Trial summary
Dehydroepiandrostrone (DHEA) and its sulfated ester (DHEAS) are high circulating weak androgens which have been associated with conditions that accompany age-related decline such as sarcopenia, hyperinsulinemia, osteopenia, and cardiovascular disease. Read more about this study
- Who is it for?
- Ages 55 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- DHEA
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Apr 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects will be postmenopausal women between the ages of 60 and 75 years old.
- Women with levels of DHEA less than 110 mg will be selected.
Who cannot join
- Individuals with history or biochemical evidence of liver disease, cardiovascular disease (other than controlled hypertension); polycythemia, cerebrovascular disorders, or disorder of glucose metabolism with fasting hyperglycemia or hypoglycemia will be excluded.
- Use of psycotropic drugs within six months prior to enrollment
- History of severe depression or psychotic disorder
- Professional athletes or BMI greater than 30kg/m2
- Anyone who has been in a regular (greater than twice/weekly) exercise program for more than 2 months prior to the study
- Severe rheumatologic condition with chronic pain not well controlled.
- Use of DHEA, estrogen, progesterone, testosterone, corticosteroid products up to six months prior to study
Trial locations and contacts
1 site in 1 country.
About this study
Dehydroepiandrostrone (DHEA) and its sulfated ester (DHEAS) are high circulating weak androgens which have been associated with conditions that accompany age-related decline such as sarcopenia, hyperinsulinemia, osteopenia, and cardiovascular disease. The decline in DHEA with age is particularly marked in postmenopausal women. Exercise has always been advocated in women; benefit has been demonstrated inmuscle, bone and lipid physiology, as well as perception of energy and sense of well-being. This study aims to explore the combined effect of both DHEA and exercise in postmenopausal women, age range 55-75 years old. Subjects will receive DHEA (50mg/day) or placebo for a 12-week period. At the beginning and conclusion of the study patients will undergo testing for muscle strength, body composition, VO2 max, insulin sensitivity, muscle biopsy with mitochondria enzyme measurements, and psychological analysis. Blood samples pre and post intervention will also be obtained and the level of selected anabolic markers, lipids, and androgenic and sex steroid levels will be assessed. For the twelve-week period, both placebo and DHEA treated participants will be involved in a resistance and aerobic exercise program coordinated through the GCRC and the Dan Abraham Healthy Living Center. Several correlations have been established with respect to exogenous DHEA administration in postmenopausal women. None have evaluated oral DHEA therapy in the setting resistance and aerobic exercise, key therapies advocated in postmenopausal women. As a plausible anabolic hormone DHEA is hypothesized to accentuate the effects of exercise as has been shown for testosterone. This study, as a randomized double-blind placebo controlled trial, will investigate the effects, if any, of a regimented exercise program and DHEA supplementation in postmenopausal women, specifically for evidence of enhancement of exercise effect by oral supplementation with DHEA in attenuating age-related decline
- Conditions
- Aging
- Being tested
- DHEA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHEADrug
What is being measured
The primary outcome is the main question the study is designed to answer.
physical performance (VO2 peak, muscle strength as measured by chest press, double knee extension, and isokinetic knee extension
quality of life
glucose and insulin metabolism
muscle protein synthesis
body composition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2007 (estimated)
- Study startApr 2003
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 32 participants
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institutes of Health (NIH)
- Investigators
- K. Sreekumaran Nair, M.D., Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00434915
- Sponsor's protocol ID
- 2010-02
- Other IDs
- P01AG014383
- Status last verified
- Mar 2011
- First submitted
- 12 Feb 2007
- Last updated
- 23 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does DHEA Enhance the Effects of Exercise in Postmenopausal Women?
- ClinicalTrials.gov ID
- NCT00434915
- Acronym / sponsor ID
- 2010-02
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institutes of Health (NIH)
- Study start
- Apr 2003
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 14 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dehydroepiandrostrone (DHEA) and its sulfated ester (DHEAS) are high circulating weak androgens which have been associated with conditions that accompany age-related decline such as sarcopenia, hyperinsulinemia, osteopenia, and cardiovascular disease. The decline in DHEA with age is particularly marked in postmenopausal women. Exercise has always been advocated in women; benefit has been demonstrated inmuscle, bone and lipid physiology, as well as perception of energy and sense of well-being. This study aims to explore the combined effect of both DHEA and exercise in postmenopausal women, age range 55-75 years old. Subjects will receive DHEA (50mg/day) or placebo for a 12-week period. At the beginning and conclusion of the study patients will undergo testing for muscle strength, body composition, VO2 max, insulin sensitivity, muscle biopsy with mitochondria enzyme measurements, and psychological analysis. Blood samples pre and post intervention will also be obtained and the level of selected anabolic markers, lipids, and androgenic and sex steroid levels will be assessed. For the twelve-week period, both placebo and DHEA treated participants will be involved in a resistance and aerobic exercise program coordinated through the GCRC and the Dan Abraham Healthy Living Center. Several correlations have been established with respect to exogenous DHEA administration in postmenopausal women. None have evaluated oral DHEA therapy in the setting resistance and aerobic exercise, key therapies advocated in postmenopausal women. As a plausible anabolic hormone DHEA is hypothesized to accentuate the effects of exercise as has been shown for testosterone. This study, as a randomized double-blind placebo controlled trial, will investigate the effects, if any, of a regimented exercise program and DHEA supplementation in postmenopausal women, specifically for evidence of enhancement of exercise effect by oral supplementation with DHEA in attenuating age-related decline
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects will be postmenopausal women between the ages of 60 and 75 years old.
- Women with levels of DHEA less than 110 mg will be selected.
Key exclusion criteria (7 listed)
- Individuals with history or biochemical evidence of liver disease, cardiovascular disease (other than controlled hypertension); polycythemia, cerebrovascular disorders, or disorder of glucose metabolism with fasting hyperglycemia or hypoglycemia will be excluded.
- Use of psycotropic drugs within six months prior to enrollment
- History of severe depression or psychotic disorder
- Professional athletes or BMI greater than 30kg/m2
- Anyone who has been in a regular (greater than twice/weekly) exercise program for more than 2 months prior to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DHEA | Drug | – |
Primary outcome
physical performance (VO2 peak, muscle strength as measured by chest press, double knee extension, and isokinetic knee extension
quality of life
glucose and insulin metabolism
muscle protein synthesis
body composition
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
K. Sreekumaran Nair, M.D., Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DHEA in people with Aging, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physical performance (VO2 peak, muscle strength as measured by chest press, double knee extension, and isokinetic knee extension. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2011; AzTrials last refreshed its copy on 7 Nov 2026.