- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00761553
Dietary Supplements and Exercise in Aging Adults
January 16, 2013 updated by: Wayne Campbell, Purdue University
The purpose of this study is to determine the effects of food supplements and strength training on appetite, the amount of energy used, and body composition.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
49
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
-
-
Indiana
-
West Lafayette, Indiana, United States, 47907
- Purdue University
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults age 55 and older
- Body mass index 20 to ≤35 kg/m2
- Weight stable (<4kg change within the last 3 months)
- Constant habitual activity patterns (no deviation > 1x/wk of 30 min/session within last 3 months)
- Clinically normal blood and urine profiles as determined by our study physician
- Not taking medications known to influence appetite nor any anti-inflammatory steroid medications
- No hip replacements
Exclusion Criteria:
- Adults with medical conditions that might place them at risk for participating in the study or interfere with the successful completion of the study protocol will be excluded
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Solid dietary supplements with exercise
|
Resistive exercise along with consuming two dietary supplements every day during both 8 week intervention periods, for a total of 16 weeks.
|
|
Experimental: 2
Solid dietary supplements without exercise
|
Consuming two dietary supplements every day during both 8 week intervention periods, for a total of 16 weeks.
|
|
Experimental: 3
Liquid dietary supplements with exercise
|
Resistive exercise along with consuming two dietary supplements every day during both 8 week intervention periods, for a total of 16 weeks.
|
|
Experimental: 4
Liquid supplements without exercise
|
Consuming two dietary supplements every day during both 8 week intervention periods, for a total of 16 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Appetite questionnaire, urine collection, strength testing, body composition, resting metabolic rate, food records, breath sample, activity assessments, dietary supplements, nightly logs, and resistive exercise.
Time Frame: 23 weeks
|
23 weeks
|
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
October 1, 2005
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
September 25, 2008
First Submitted That Met QC Criteria
September 26, 2008
First Posted (Estimate)
September 29, 2008
Study Record Updates
Last Update Posted (Estimate)
January 17, 2013
Last Update Submitted That Met QC Criteria
January 16, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- 0509003026
- NIH/NIA 5R01AG021911
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.