SarcopeniaPROMONCT06235476
Protein Intake and Exercise-induced Muscle Damage
A study testing whey protein supplement, mixed plant-based protein supplement and e-health application in people with Sarcopenia, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The goal of this clinical trial is to test the effect of different protein-enhancement strategies versus carbohydrate control on exercise-induced muscle damage in physically active older adults. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- whey protein supplement, mixed plant-based protein supplement and e-health application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Jun 2024to 31 Jul 2025
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 years or older
- Registered for the Nijmegen Four Days Marches (i.e., able to walk 30-50 km/day)
- A habitual protein intake <1.0 g/kg/d based on the protein 55+ (PRO55+) screening tool
- Able to understand and perform the study procedures
- Able to use a mobile device
Who cannot join
- Allergic or sensitive for milk proteins, or lactose intolerant
- Diagnosed type I or type II diabetes mellitus
- Diagnosed intestinal diseases influencing the uptake of protein (i.e., active inflammatory bowel disease, Crohn's disease)
- Consumption of other freely available protein supplements during the study period.
- If the subject intends to perform additional exercise bouts that cause muscle damage in the 4 days before the single- and multiple exercise bouts.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Effects of Three PROtein-enhancement Strategies on Exercise-induced Muscle Damage in Older Adults
The goal of this clinical trial is to test the effect of different protein-enhancement strategies versus carbohydrate control on exercise-induced muscle damage in physically active older adults. The main question it aims to answer is:
What is the effect of three different protein-enhancement strategies (whey protein (WP), mixed plant-based protein (MPP), and use of protein-rich food products (PFP) on exercise-induced muscle damage in older adults compared to isocaloric carbohydrate control?
Read more
Participants will:
- Use a protein-enhancement strategy (WP, MPP or PFP) or carbohydrate control for a total of 5 weeks;
- Participate in a single walking bound (30/40/50 km) two weeks after the start of the study;
- Participate in a consecutive walking bound (4 days of 30/40/50 km) in the last week of the study period;
- Complete different questionnaires and give blood samples to test for muscle damage.
- Conditions
- Sarcopenia
- Being tested
- whey protein supplement, mixed plant-based protein supplement, e-health application, isocaloric carbohydrate control
- Keywords
- Protein intake, Muscle damage, Nutritional intervention, Supplements, e-health
- 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 supplementDietary supplement
Daily dosage of the supplements will be 30 gram, preferably consumed in the morning and post-exercise or prior to sleep.
mixed plant-based protein supplementDietary supplement
Daily dosage of the supplements will be 30 gram, preferably consumed in the morning and post-exercise or prior to sleep.
e-health applicationOther
Daily use of an e-health application with dietary intake counselling to increase protein intake. The overall goal of these advices is to increase protein intake from <1.0g/kg/bw/d to >1.2g/kg/bw/d which is approximately 30 grams of additional protein per day (similar to the other arms of the intervention).
isocaloric carbohydrate controlDietary supplement
Daily dosage of the supplements will be 30 gram, preferably consumed in the morning and post-exercise or prior to sleep.
| Study group | Role | What they receive |
|---|---|---|
| animal-based protein (WP) | Experimental | Supplements and control (MPP, WP, CON) will be consumed as a drink or in a recipe for five subsequent weeks (30 g/day); four weeks preload and one week during the Four Days Marches. With this amount, we aim to increase the protein intake from <1.0g/kg/bw/d to >1.2g/kg/bw/d. Participants are allowed to dissolve the powder in a liquid of choice: we will provide several examples to the participants during the instructions. Receives: Dietary Supplement: whey protein supplement |
| plant-based protein (MPP) | Experimental | Supplements and control (MPP, WP, CON) will be consumed as a drink or in a recipe for five subsequent weeks (30 g/day); four weeks preload and one week during the Four Days Marches. With this amount, we aim to increase the protein intake from <1.0g/kg/bw/d to >1.2g/kg/bw/d. Participants are allowed to dissolve the powder in a liquid of choice: we will provide several examples to the participants during the instructions. Receives: Dietary Supplement: mixed plant-based protein supplement |
| protein-rich food products (PFP) | Experimental | PFP will receive digitally supported dietary intake counselling, with a focus on the use of protein-enriched food products in order to increase protein intake up to >1.2 k/kg/bw/d. Receives: Other: e-health application |
| control (CON) | Active comparator | Supplements and control (MPP, WP, CON) will be consumed as a drink or in a recipe for five subsequent weeks (30 g/day); four weeks preload and one week during the Four Days Marches. With this amount, we aim to increase the protein intake from <1.0g/kg/bw/d to >1.2g/kg/bw/d. Participants are allowed to dissolve the powder in a liquid of choice: we will provide several examples to the participants during the instructions. Receives: Dietary Supplement: isocaloric carbohydrate control |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum creatine kinase (CK) levels
Exercise-induced muscle damage. Non-fasted venous blood samples will be drawn from the antecubital vein at each pre-exercise and post-exercise visit. Based on previous research it is expected that time-dependent exercise-induced increase in creatine kinase (CK) levels are significantly different between protein groups and control, but not within protein groups. Multiple peak post-exercise CK concentrations (several hours to up to 48h post exercise) will be compared to pre-exercise CK levels to compare the effect of different protein enhancing strategies versus carbohydrate control.
Measured: Measured 8 times in total. Once pre-single exercise, two times post-single exercise (within 2h after and around 24h after) and 2 weeks later: once pre-multiple day exercise and four times post-multiple day exercise (within 2h post-exercise)
Secondary outcomes (3)
serum lactate dehydrogenase (LDH) levels
(Muscle) cell damage. Non-fasted venous blood samples will be drawn from the antecubital vein at each pre-exercise and post-exercise visit.
Measured: Measured 8 times in total. Once pre-single exercise, two times post-single exercise (within 2h after and around 24h after) and 2 weeks later: once pre-multiple day exercise and four times post-multiple day exercise (within 2h post-exercise)
muscle soreness
Muscle soreness is measured via the the Numeric Pain Scale (from 0 to 10, a higher score means more muscle soreness.
Measured: Measured 8 times in total. Once pre-single exercise, two times post-single exercise (within 2h after and around 24h after) and 2 weeks later: once pre-multiple day exercise and four times post-multiple day exercise (within 2h post-exercise)
muscle function
Maximal handgrip strength is measured to the nearest 0.5 kg using a hand dynamometer. The participants is seated in a chair with the shoulders adducted and neutrally rotated and elbow flexed at 90o. Three consecutive measurements of handgrip strength will be recorded.
Measured: Measured 8 times in total. Once pre-single exercise, two times post-single exercise (within 2h after and around 24h after) and 2 weeks later: once pre-multiple day exercise and four times post-multiple day exercise (within 2h post-exercise)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start10 Jun 2024
- Primary completion19 Jul 2024
- Study completion31 Jul 2025
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 4-arm intervention study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cosun
- Responsible party
- Sponsor
- Investigators
- Maria Hopman, prof. dr., Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235476
- Sponsor's protocol ID
- 86007.091.23
- Acronym
- PROMO
- Status last verified
- Oct 2025
- First submitted
- 21 Dec 2023
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data (IPD) will be shared with researchers within the department of Medical Biosciences of the Radboud University Medical Center (Radboudumc). The department has a database of data from the past 15 years of Four Day Marches data. This research data will be added to the database. Data may be shared with other researchers upon request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effects of Three PROtein-enhancement Strategies on Exercise-induced Muscle Damage in Older Adults
- ClinicalTrials.gov ID
- NCT06235476
- Acronym / sponsor ID
- PROMO / 86007.091.23
- Conditions
- Sarcopenia
- Keywords
- Protein intake, Muscle damage, Nutritional intervention, Supplements, e-health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Cosun
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 19 Jul 2024 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 1 Feb 2024 (actual)
- 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 goal of this clinical trial is to test the effect of different protein-enhancement strategies versus carbohydrate control on exercise-induced muscle damage in physically active older adults. The main question it aims to answer is:
What is the effect of three different protein-enhancement strategies (whey protein (WP), mixed plant-based protein (MPP), and use of protein-rich food products (PFP) on exercise-induced muscle damage in older adults compared to isocaloric carbohydrate control?
Participants will:
- Use a protein-enhancement strategy (WP, MPP or PFP) or carbohydrate control for a total of 5 weeks;
- Participate in a single walking bound (30/40/50 km) two weeks after the start of the study;
- Participate in a consecutive walking bound (4 days of 30/40/50 km) in the last week of the study period;
- Complete different questionnaires and give blood samples to test for muscle damage.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- 4-arm intervention study
| Arm | Type | Receives |
|---|---|---|
| animal-based protein (WP) | Experimental | Dietary Supplement: whey protein supplementSupplements and control (MPP, WP, CON) will be consumed as a drink or in a recipe for five subsequent weeks (30 g/day); four weeks preload and one week during the Four Days Marches. With this amount, we aim to increase the protein intake from <1.0g/kg/bw/d to >1.2g/kg/bw/d. Participants are allowed to dissolve the powder in a liquid of choice: we will provide several examples to the participants during the instructions. |
| plant-based protein (MPP) | Experimental | Dietary Supplement: mixed plant-based protein supplementSupplements and control (MPP, WP, CON) will be consumed as a drink or in a recipe for five subsequent weeks (30 g/day); four weeks preload and one week during the Four Days Marches. With this amount, we aim to increase the protein intake from <1.0g/kg/bw/d to >1.2g/kg/bw/d. Participants are allowed to dissolve the powder in a liquid of choice: we will provide several examples to the participants during the instructions. |
| protein-rich food products (PFP) | Experimental | Other: e-health applicationPFP will receive digitally supported dietary intake counselling, with a focus on the use of protein-enriched food products in order to increase protein intake up to >1.2 k/kg/bw/d. |
| control (CON) | Active comparator | Dietary Supplement: isocaloric carbohydrate controlSupplements and control (MPP, WP, CON) will be consumed as a drink or in a recipe for five subsequent weeks (30 g/day); four weeks preload and one week during the Four Days Marches. With this amount, we aim to increase the protein intake from <1.0g/kg/bw/d to >1.2g/kg/bw/d. Participants are allowed to dissolve the powder in a liquid of choice: we will provide several examples to the participants during the instructions. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 60 years or older
- Registered for the Nijmegen Four Days Marches (i.e., able to walk 30-50 km/day)
- A habitual protein intake <1.0 g/kg/d based on the protein 55+ (PRO55+) screening tool
- Able to understand and perform the study procedures
- Able to use a mobile device
Key exclusion criteria (5 listed)
- Allergic or sensitive for milk proteins, or lactose intolerant
- Diagnosed type I or type II diabetes mellitus
- Diagnosed intestinal diseases influencing the uptake of protein (i.e., active inflammatory bowel disease, Crohn's disease)
- Consumption of other freely available protein supplements during the study period.
- If the subject intends to perform additional exercise bouts that cause muscle damage in the 4 days before the single- and multiple exercise bouts.
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 supplementDaily dosage of the supplements will be 30 gram, preferably consumed in the morning and post-exercise or prior to sleep. | Dietary supplement | animal-based protein (WP) |
| mixed plant-based protein supplementDaily dosage of the supplements will be 30 gram, preferably consumed in the morning and post-exercise or prior to sleep. | Dietary supplement | plant-based protein (MPP) |
| e-health applicationDaily use of an e-health application with dietary intake counselling to increase protein intake. The overall goal of these advices is to increase protein intake from <1.0g/kg/bw/d to >1.2g/kg/bw/d which is approximately 30 grams of additional protein per day (similar to the other arms of the intervention). | Other | protein-rich food products (PFP) |
| isocaloric carbohydrate controlDaily dosage of the supplements will be 30 gram, preferably consumed in the morning and post-exercise or prior to sleep. | Dietary supplement | control (CON) |
Primary outcome
serum creatine kinase (CK) levels
Time frame: Measured 8 times in total. Once pre-single exercise, two times post-single exercise (within 2h after and around 24h after) and 2 weeks later: once pre-multiple day exercise and four times post-multiple day exercise (within 2h post-exercise)
Exercise-induced muscle damage. Non-fasted venous blood samples will be drawn from the antecubital vein at each pre-exercise and post-exercise visit. Based on previous research it is expected that time-dependent exercise-induced increase in creatine kinase (CK) levels are significantly different between protein groups and control, but not within protein groups. Multiple peak post-exercise CK concentrations (several hours to up to 48h post exercise) will be compared to pre-exercise CK levels to compare the effect of different protein enhancing strategies versus carbohydrate control.
3 secondary outcomes
serum lactate dehydrogenase (LDH) levels
Time frame: Measured 8 times in total. Once pre-single exercise, two times post-single exercise (within 2h after and around 24h after) and 2 weeks later: once pre-multiple day exercise and four times post-multiple day exercise (within 2h post-exercise)
muscle soreness
Time frame: Measured 8 times in total. Once pre-single exercise, two times post-single exercise (within 2h after and around 24h after) and 2 weeks later: once pre-multiple day exercise and four times post-multiple day exercise (within 2h post-exercise)
muscle function
Time frame: Measured 8 times in total. Once pre-single exercise, two times post-single exercise (within 2h after and around 24h after) and 2 weeks later: once pre-multiple day exercise and four times post-multiple day exercise (within 2h post-exercise)
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 Nov 2025.
- Individual participant dataSharing planned: Yes. Individual Participant Data (IPD) will be shared with researchers within the department of Medical Biosciences of the Radboud University Medical Center (Radboudumc). The department has a database of data from the past 15 years of Four Day Marches data. This research data will be added to the database. Data may be shared with other researchers upon request.
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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.
Maria Hopman, prof. dr. principal investigator
Radboud University Medical Center
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 supplement, mixed plant-based protein supplement and e-health application in people with Sarcopenia, run by Radboud University Medical Center 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 5 inclusion and 5 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 Nov 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. 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?
serum creatine kinase (CK) levels (time frame: Measured 8 times in total. Once pre-single exercise, two times post-single exercise (within 2h after and around 24h after) and 2 weeks later: once pre-multiple day exercise and four times post-multiple day exercise (within 2h post-exercise)). 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 Nov 2025.