SarcopeniaProMuscleNCT01110369
A Protein Supplementation and Exercise Strategy to Promote Muscle Protein Anabolism in Frail Elderly People
A study testing Protein drink and Resistance exercise training in people with Sarcopenia, run by Wageningen University at 1 site in Netherlands.
Trial summary
The present study is designed to investigate whether timed protein supplementation will increase skeletal muscle mass in the frail elderly population. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Protein drink and Resistance exercise training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2009to Jul 2011
- 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
- No healthy volunteers
- Older adult
Who may be able to join
- Frail elderly individuals
- Able to understand and perform the study procedures
Who cannot join
- Type I or type II diabetes (fasted blood glucose level ≥7,0 mmol)
- No recent history (within 2 years) of participating in any regular resistance exercise training program (general questionnaire)
- Use of anti-coagulation medication (except of Acetyl Salicyl acid)
- Presence of coronary heart disease (ECG)
- Renal insufficiency (eGFR <60 mL/min/1.73 m2)
- Allergic or sensitive for milk proteins
Trial locations and contacts
1 site in 1 country.
About this study
The present study is designed to investigate whether timed protein supplementation will increase skeletal muscle mass in the frail elderly population.
- Conditions
- Sarcopenia
- Being tested
- Protein drink, Resistance exercise training, Placebo drink
- Keywords
- sarcopenia, frail elderly, protein drink, resistance exercise, Skeletal muscle mass, muscle mass in elderly
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein drinkDietary supplement
Protein drink twice a day during 6 months.
Resistance exercise trainingOther
Resistance exercise training twice per week during 6 months.
Placebo drinkDietary supplement
Placebo drink twice a day during 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Resistance exercise training and protein drink | Experimental | Not described Receives: Dietary Supplement: Protein drink; Other: Resistance exercise training |
| Resistance exercise training and placebo drink | Placebo comparator | Not described Receives: Other: Resistance exercise training; Dietary Supplement: Placebo drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in skeletal muscle mass
Measured: Baseline, 3 months and 6 months
Secondary outcomes (6)
Physical performance
Measured: Baseline, 3 months and 6 months
Blood will be collected to assess parameters related to the outcome measures
Measured: Baseline, 3 months and 6 months
Dietary intake
Measured: Baseline, 3 months and 6 months
Physical activity
Measured: Baseline, 3 months and 6 months
Cognitive performance
Measured: Baseline and 6 months
Blood pressure
Measured: Baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2010 (estimated)
- Study startNov 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Top Institute Food and Nutrition, Maastricht University Medical Center
- Responsible party
- Principal investigator, Lisette de Groot, Wageningen University
- Investigators
- Lisette de Groot, Professor, Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110369
- Sponsor's protocol ID
- A1002-2
- Acronym
- ProMuscle
- Status last verified
- Apr 2025
- First submitted
- 12 Feb 2010
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Dorhout BG, de Groot LCPGM, van Dongen EJI, Doets EL, Haveman-Nies A. Effects and contextual factors of a diet and resistance exercise intervention vary across settings: an overview of three successive ProMuscle interventions. BMC Geriatr. 2022 Mar 9;22(1):189. doi: 10.1186/s12877-021-02733-6.
PubMed 35264105van de Rest O, van der Zwaluw NL, Tieland M, Adam JJ, Hiddink GJ, van Loon LJ, de Groot LC. Effect of resistance-type exercise training with or without protein supplementation on cognitive functioning in frail and pre-frail elderly: secondary analysis of a randomized, double-blind, placebo-controlled trial. Mech Ageing Dev. 2014 Mar-Apr;136-137:85-93. doi: 10.1016/j.mad.2013.12.005. Epub 2013 Dec 27.
PubMed 24374288Tieland M, Dirks ML, van der Zwaluw N, Verdijk LB, van de Rest O, de Groot LC, van Loon LJ. Protein supplementation increases muscle mass gain during prolonged resistance-type exercise training in frail elderly people: a randomized, double-blind, placebo-controlled trial. J Am Med Dir Assoc. 2012 Oct;13(8):713-9. doi: 10.1016/j.jamda.2012.05.020. Epub 2012 Jul 6.
PubMed 22770932
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Protein Supplementation and Exercise Strategy to Promote Muscle Protein Anabolism in Frail Elderly People
- ClinicalTrials.gov ID
- NCT01110369
- Acronym / sponsor ID
- ProMuscle / A1002-2
- Conditions
- Sarcopenia
- Keywords
- sarcopenia, frail elderly, protein drink, resistance exercise, Skeletal muscle mass, muscle mass in elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Top Institute Food and Nutrition, Maastricht University Medical Center
- Study start
- Nov 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 26 Apr 2010 (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 present study is designed to investigate whether timed protein supplementation will increase skeletal muscle mass in the frail elderly population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance exercise training and protein drink | Experimental | Dietary Supplement: Protein drink, Other: Resistance exercise training |
| Resistance exercise training and placebo drink | Placebo comparator | Other: Resistance exercise training, Dietary Supplement: Placebo drink |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Frail elderly individuals
- Able to understand and perform the study procedures
Key exclusion criteria (6 listed)
- Type I or type II diabetes (fasted blood glucose level ≥7,0 mmol)
- No recent history (within 2 years) of participating in any regular resistance exercise training program (general questionnaire)
- Use of anti-coagulation medication (except of Acetyl Salicyl acid)
- Presence of coronary heart disease (ECG)
- Renal insufficiency (eGFR <60 mL/min/1.73 m2)
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 |
|---|---|---|
| Protein drinkProtein drink twice a day during 6 months. | Dietary supplement | Resistance exercise training and protein drink |
| Resistance exercise trainingResistance exercise training twice per week during 6 months. | Other | Resistance exercise training and placebo drink, Resistance exercise training and protein drink |
| Placebo drinkPlacebo drink twice a day during 6 months. | Dietary supplement | Resistance exercise training and placebo drink |
Primary outcome
Change in skeletal muscle mass
Time frame: Baseline, 3 months and 6 months
6 secondary outcomes
Physical performance
Time frame: Baseline, 3 months and 6 months
Blood will be collected to assess parameters related to the outcome measures
Time frame: Baseline, 3 months and 6 months
Dietary intake
Time frame: Baseline, 3 months and 6 months
Physical activity
Time frame: Baseline, 3 months and 6 months
Cognitive performance
Time frame: Baseline and 6 months
Blood pressure
Time frame: Baseline, 3 months and 6 months
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 4 Apr 2025.
- Derived from this study: PubMed 35264105Dorhout BG, de Groot LCPGM, van Dongen EJI, Doets EL, Haveman-Nies A. Effects and contextual factors of a diet and resistance exercise intervention vary across settings: an overview of three successive ProMuscle interventions. BMC Geriatr. 2022 Mar 9;22(1):189. doi: 10.1186/s12877-021-02733-6.
- Derived from this study: PubMed 24374288van de Rest O, van der Zwaluw NL, Tieland M, Adam JJ, Hiddink GJ, van Loon LJ, de Groot LC. Effect of resistance-type exercise training with or without protein supplementation on cognitive functioning in frail and pre-frail elderly: secondary analysis of a randomized, double-blind, placebo-controlled trial. Mech Ageing Dev. 2014 Mar-Apr;136-137:85-93. doi: 10.1016/j.mad.2013.12.005. Epub 2013 Dec 27.
- Derived from this study: PubMed 22770932Tieland M, Dirks ML, van der Zwaluw N, Verdijk LB, van de Rest O, de Groot LC, van Loon LJ. Protein supplementation increases muscle mass gain during prolonged resistance-type exercise training in frail elderly people: a randomized, double-blind, placebo-controlled trial. J Am Med Dir Assoc. 2012 Oct;13(8):713-9. doi: 10.1016/j.jamda.2012.05.020. Epub 2012 Jul 6.
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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.
Lisette de Groot, Professor principal investigator
Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein drink and Resistance exercise training in people with Sarcopenia, run by Wageningen University at 1 site in Netherlands.
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 2 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 4 Apr 2025. 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 Netherlands. 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?
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?
Change in skeletal muscle mass (time frame: Baseline, 3 months and 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 NCT01110369, which also lists 3 linked publications.
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 4 Apr 2025.