SarcopeniaS32NCT02069314
Diet and Muscle Function In Older Adults
A study testing Whey protein supplementation and Carbohydrate (polycose) supplementation in people with Sarcopenia, run by Purdue University at 1 site in United States.
Trial summary
This research study was conducted to investigate the effects of a high protein diet on the efficiency of energy use at rest and at low-levels of physical activity. The hypothesis was that a high intake of dietary protein would result in a less efficient use of energy in skeletal muscle in older adults. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Whey protein supplementation and Carbohydrate (polycose) supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to May 2013
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 years and older
Who cannot join
- Diabetic
- Acute symptoms of cardiovascular disease or congestive heart failure
- uncontrolled hypertension
- supplemental oxygen consumption at rest or during exercise
- lactose intolerance
- inability to ride a stationary cycle
Trial locations and contacts
1 site in 1 country.
About this study
This research study was conducted to investigate the effects of a high protein diet on the efficiency of energy use at rest and at low-levels of physical activity. The hypothesis was that a high intake of dietary protein would result in a less efficient use of energy in skeletal muscle in older adults.
Read the detailed description
This research study was conducted to investigate the effects of a high protein diet on the efficiency of energy use at rest and at low-levels of physical activity. The hypothesis was that a high intake of dietary protein would result in a less efficient use of energy in skeletal muscle in older adult
- Conditions
- Sarcopenia
- Being tested
- Whey protein supplementation, Carbohydrate (polycose) supplementation
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey protein supplementationDietary supplement
subjects are asked to consume a smoothie with whey protein added
Carbohydrate (polycose) supplementationDietary supplement
Subjects are asked to consume a beverage with polycose added
| Study group | Role | What they receive |
|---|---|---|
| Whey protein supplementation | Experimental | 50 grams of whey blended into frozen drink Receives: Dietary Supplement: Whey protein supplementation |
| Carbohydrate supplementation | Experimental | 50 grams of polycose blended into frozen drink Receives: Dietary Supplement: Carbohydrate (polycose) supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary protein effects on muscle energy use
gross mechanical efficiency of muscle, consuming high and low protein supplements
Measured: participants will be measured over an average of 26 days
Secondary outcomes (1)
Effect of protein supplements on food intake
effects of high protein or high carbohydrate supplements on overall energy consumption in older adults.
Measured: participants will be measured over an average of 26 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startMay 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wayne Campbell, Purdue University
- Investigators
- Wayne W Campbell, Ph.D., Principal investigator, Purdue University Dept of Nutrition Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069314
- Sponsor's protocol ID
- 1203012093
- Acronym
- S32
- Status last verified
- May 2013
- First submitted
- 12 Feb 2014
- Last updated
- 24 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet and Muscle Function In Older Adults
- ClinicalTrials.gov ID
- NCT02069314
- Acronym / sponsor ID
- S32 / 1203012093
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 24 Feb 2014 (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.
This research study was conducted to investigate the effects of a high protein diet on the efficiency of energy use at rest and at low-levels of physical activity. The hypothesis was that a high intake of dietary protein would result in a less efficient use of energy in skeletal muscle in older adults.
Detailed description
This research study was conducted to investigate the effects of a high protein diet on the efficiency of energy use at rest and at low-levels of physical activity. The hypothesis was that a high intake of dietary protein would result in a less efficient use of energy in skeletal muscle in older adult
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whey protein supplementation | Experimental | Dietary Supplement: Whey protein supplementation50 grams of whey blended into frozen drink |
| Carbohydrate supplementation | Experimental | Dietary Supplement: Carbohydrate (polycose) supplementation50 grams of polycose blended into frozen drink |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 65 years and older
Key exclusion criteria (6 listed)
- Diabetic
- Acute symptoms of cardiovascular disease or congestive heart failure
- uncontrolled hypertension
- supplemental oxygen consumption at rest or during exercise
- lactose intolerance
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 |
|---|---|---|
| Whey protein supplementationsubjects are asked to consume a smoothie with whey protein added | Dietary supplement | Whey protein supplementation |
| Carbohydrate (polycose) supplementationSubjects are asked to consume a beverage with polycose added | Dietary supplement | Carbohydrate supplementation |
Primary outcome
Dietary protein effects on muscle energy use
Time frame: participants will be measured over an average of 26 days
gross mechanical efficiency of muscle, consuming high and low protein supplements
1 secondary outcome
Effect of protein supplements on food intake
Time frame: participants will be measured over an average of 26 days
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 24 Feb 2014.
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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.
Wayne W Campbell, Ph.D. principal investigator
Purdue University Dept of Nutrition Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein supplementation and Carbohydrate (polycose) supplementation in people with Sarcopenia, 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 1 inclusion and 6 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 24 Feb 2014. 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?
Dietary protein effects on muscle energy use (time frame: participants will be measured over an average of 26 days). 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 24 Feb 2014.