Mobility LimitationNCT00635739
Effect of Whey Protein Supplementation and Resistance Exercise on Muscle Parameters in Older Adults
A study testing Whey protein in people with Mobility Limitation, run by Tufts University at 1 site in United States.
Trial summary
This research study is looking at the effects of a whey protein nutritional supplement on changes in muscle mass, strength and physical function in response to a 6 month program of strength training exercise. Read more about this study
- Who is it for?
- Ages 70 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Mobility Limitation
- What is being tested?
- Whey protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Male and Females 70-85 yrs
- Community dwelling
- Short Physical Performance Battery score < 10
- BMI = 21-32.5
Who cannot join
- Acute or terminal illness
- Mini Mental State Exam < 23
- Myocardial infarction in previous 6 months, symptomatic coronary artery disease, or congestive heart failure
- Upper or lower extremity fracture in previous 6 months
- Uncontrolled hypertension (>150/90 mm Hg).
- Neuromuscular diseases and drugs which affect neuromuscular function.
Show all 13Show fewer
- Hormone replacement therapy
- eGFR <30 mL/min/1.73m2
- Types I and II Diabetes Mellitus
- Dietary protein intake < 0.8 g.kg-1.day-1
- Disorders of nutrient absorption
- Milk, or whey allergy
- Sulfa drugs and allergy to PABA-containing sunscreens
Trial locations and contacts
1 site in 1 country.
United States1 site
Jean Mayer USDA Human Nutrition Research Center on Aging
Boston, Massachusetts, 02111
About this study
Official title: Efficacy of Whey Protein Supplementation on Resistance Exercise-Induced Changes in Muscle Strength, Fat Free Mass, and Function in Mobility-Limited Older Adults
This research study is looking at the effects of a whey protein nutritional supplement on changes in muscle mass, strength and physical function in response to a 6 month program of strength training exercise.
- Conditions
- Mobility Limitation
- Being tested
- Whey protein, Maltodextrin placebo
- Keywords
- Whey protein, Resistance exercise, Physical activity, Mobility disability, Physical function, Muscle mass, Muscle strength, Older Adults, Mobility-Limited
- Medical subject headings
- Mobility Limitation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey proteinDietary supplement
powdered, 46g supplement dissolved in fluids, twice daily
Maltodextrin placeboDietary supplement
powdered, 46g supplement dissolved in fluids, twice daily
| Study group | Role | What they receive |
|---|---|---|
| A, 1 | Active comparator | Not described Receives: Dietary Supplement: Whey protein |
| A, 2 | Placebo comparator | Not described Receives: Dietary Supplement: Maltodextrin placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 Repetition Maximum Muscle Strength 1-RM (N) Double Leg Press
The maximum muscle strength of the leg extensor muscles as measured by pneumatic strength training equipment.
Measured: Baseline and follow up (6 months)
Secondary outcomes (1)
Lean Mass
Whole body lean mass (kg) as measured by dual energy x-ray absorptiometry.
Measured: Baseline and follow up (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mobility LimitationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- National Dairy Council
- Responsible party
- Principal investigator, Roger A Fielding, Tufts University
- Investigators
- Roger A Fielding, Ph.D., Principal investigator, Jean Mayer USDA Human Nutrition Research Center on Aging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635739
- Sponsor's protocol ID
- 1493
- Status last verified
- Dec 2018
- First submitted
- 7 Mar 2008
- Last updated
- 18 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Chale A, Cloutier GJ, Hau C, Phillips EM, Dallal GE, Fielding RA. Efficacy of whey protein supplementation on resistance exercise-induced changes in lean mass, muscle strength, and physical function in mobility-limited older adults. J Gerontol A Biol Sci Med Sci. 2013 Jun;68(6):682-90. doi: 10.1093/gerona/gls221. Epub 2012 Oct 31.
PubMed 23114462
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Whey Protein Supplementation on Resistance Exercise-Induced Changes in Muscle Strength, Fat Free Mass, and Function in Mobility-Limited Older Adults
- ClinicalTrials.gov ID
- NCT00635739
- Acronym / sponsor ID
- 1493
- Conditions
- Mobility Limitation
- Keywords
- Whey protein, Resistance exercise, Physical activity, Mobility disability, Physical function, Muscle mass, Muscle strength, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- National Dairy Council
- Study start
- Apr 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 14 Mar 2008 (estimated)
- Results
- Posted 18 Mar 2019
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 is looking at the effects of a whey protein nutritional supplement on changes in muscle mass, strength and physical function in response to a 6 month program of strength training exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A, 1 | Active comparator | Dietary Supplement: Whey protein |
| A, 2 | Placebo comparator | Dietary Supplement: Maltodextrin placebo |
Who may qualify
- Ages
- 70 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Male and Females 70-85 yrs
- Community dwelling
- Short Physical Performance Battery score < 10
- BMI = 21-32.5
Key exclusion criteria (13 listed)
- Acute or terminal illness
- Mini Mental State Exam < 23
- Myocardial infarction in previous 6 months, symptomatic coronary artery disease, or congestive heart failure
- Upper or lower extremity fracture in previous 6 months
- Uncontrolled hypertension (>150/90 mm Hg).
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 proteinpowdered, 46g supplement dissolved in fluids, twice daily | Dietary supplement | A, 1 |
| Maltodextrin placebopowdered, 46g supplement dissolved in fluids, twice daily | Dietary supplement | A, 2 |
Primary outcome
1 Repetition Maximum Muscle Strength 1-RM (N) Double Leg Press
Time frame: Baseline and follow up (6 months)
The maximum muscle strength of the leg extensor muscles as measured by pneumatic strength training equipment.
1 secondary outcome
Lean Mass
Time frame: Baseline and follow up (6 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23114462Chale A, Cloutier GJ, Hau C, Phillips EM, Dallal GE, Fielding RA. Efficacy of whey protein supplementation on resistance exercise-induced changes in lean mass, muscle strength, and physical function in mobility-limited older adults. J Gerontol A Biol Sci Med Sci. 2013 Jun;68(6):682-90. doi: 10.1093/gerona/gls221. Epub 2012 Oct 31.
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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.
Roger A Fielding, Ph.D. principal investigator
Jean Mayer USDA Human Nutrition Research Center on Aging
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 in people with Mobility Limitation, run by Tufts 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 4 inclusion and 13 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 18 Mar 2019. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 18 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
1 Repetition Maximum Muscle Strength 1-RM (N) Double Leg Press (time frame: Baseline and follow up (6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00635739, which also lists 1 linked publication.
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 18 Mar 2019.