ExerciseNCT00761553
Dietary Supplements and Exercise in Aging Adults
A study testing Dietary supplements with exercise and Dietary supplement without exercise in people with Exercise, run by Purdue University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Exercise
- What is being tested?
- Dietary supplements with exercise and Dietary supplement without exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Jun 2009
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Exercise
- Being tested
- Dietary supplements with exercise, Dietary supplement without exercise
- Keywords
- The study is designed to determine the effects of food supplements and strength training.
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplements with exerciseOther
Resistive exercise along with consuming two dietary supplements every day during both 8 week intervention periods, for a total of 16 weeks.
Dietary supplement without exerciseDietary supplement
Consuming two dietary supplements every day during both 8 week intervention periods, for a total of 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Solid dietary supplements with exercise Receives: Other: Dietary supplements with exercise |
| 2 | Experimental | Solid dietary supplements without exercise Receives: Dietary Supplement: Dietary supplement without exercise |
| 3 | Experimental | Liquid dietary supplements with exercise Receives: Other: Dietary supplements with exercise |
| 4 | Experimental | Liquid supplements without exercise Receives: Dietary Supplement: Dietary supplement without exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appetite questionnaire, urine collection, strength testing, body composition, resting metabolic rate, food records, breath sample, activity assessments, dietary supplements, nightly logs, and resistive exercise.
Measured: 23 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2008 (estimated)
- Study startOct 2005
- Primary completionJun 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wayne Campbell, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761553
- Sponsor's protocol ID
- 0509003026
- Other IDs
- NIH/NIA 5R01AG021911
- Status last verified
- Jan 2013
- First submitted
- 25 Sep 2008
- Last updated
- 17 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Supplements and Exercise in Aging Adults
- ClinicalTrials.gov ID
- NCT00761553
- Acronym / sponsor ID
- 0509003026
- Conditions
- Exercise
- Keywords
- The study is designed to determine the effects of food supplements and strength training.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 29 Sep 2008 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Dietary supplements with exerciseSolid dietary supplements with exercise |
| 2 | Experimental | Dietary Supplement: Dietary supplement without exerciseSolid dietary supplements without exercise |
| 3 | Experimental | Other: Dietary supplements with exerciseLiquid dietary supplements with exercise |
| 4 | Experimental | Dietary Supplement: Dietary supplement without exerciseLiquid supplements without exercise |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| Dietary supplements with exerciseResistive exercise along with consuming two dietary supplements every day during both 8 week intervention periods, for a total of 16 weeks. | Other | 1, 3 |
| Dietary supplement without exerciseConsuming two dietary supplements every day during both 8 week intervention periods, for a total of 16 weeks. | Dietary supplement | 2, 4 |
Primary outcome
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
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 17 Jan 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary supplements with exercise and Dietary supplement without exercise in people with Exercise, run by Purdue University 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 7 inclusion and 1 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 17 Jan 2013. 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?
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). 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 17 Jan 2013.