- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00434915
Does DHEA Enhance the Effects of Exercise in Postmenopausal Women?
March 22, 2011 updated by: Mayo Clinic
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 Overview
Study Type
Interventional
Enrollment
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
quality of life
|
physical performance (VO2 peak, muscle strength as measured by chest press, double knee extension, and isokinetic knee extension
|
muscle protein synthesis
|
body composition
|
glucose and insulin metabolism
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2003
Primary Completion (Actual)
April 1, 2007
Study Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
February 12, 2007
First Submitted That Met QC Criteria
February 13, 2007
First Posted (Estimate)
February 14, 2007
Study Record Updates
Last Update Posted (Estimate)
March 23, 2011
Last Update Submitted That Met QC Criteria
March 22, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- 2010-02
- P01AG014383 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aging
-
Tuba MadenCompletedAging | Aging Problems | Aging Disorder
-
Radboud University Medical CenterNot yet recruitingAging | Aging Well | Immuno Aging
-
University of Santiago de CompostelaEuropean Regional Development Fund; Center for Industrial Technological Development...Completed
-
TruDiagnosticBlushield USANot yet recruitingAging | Aging Well
-
San Diego State UniversityCompleted
-
Lithuanian Sports UniversityCompletedAging | Healthy AgingLithuania
-
Amazentis SAproDERM GmbHCompleted
-
University of West AtticaNot yet recruiting
-
University of Santiago de CompostelaAgencia Estatal de Investigación, SpainRecruiting
-
Beijing HospitalBGI-ShenzhenCompletedAging | Healthy Aging
Clinical Trials on DHEA
-
EndoCeutics Inc.Completed
-
Cairo UniversityCompleted
-
National Institute on Aging (NIA)Completed
-
Shaare Zedek Medical CenterUnknownInfertility, Female | In-Vitro Fertilization
-
The University of Hong KongCompletedFemale Infertility Due to Diminished Ovarian ReserveHong Kong
-
National Center for Complementary and Integrative...Completed
-
Virginia Center for Reproductive MedicineWithdrawn
-
Mayo ClinicNational Institutes of Health (NIH); National Institute on Aging (NIA)CompletedAging | Dehydroepiandosterone Replacement | DHEA ReplacementUnited States
-
National Institute on Aging (NIA)Completed
-
CHU de Quebec-Universite LavalCompleted