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Protein Intake and Exercise-induced Muscle Damage

Comparing the Effects of Three PROtein-enhancement Strategies on Exercise-induced Muscle Damage in Older Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06235476
Acronym
PROMO
Enrollment
199
Registered
2024-02-01
Start date
2024-06-10
Completion date
2025-07-31
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenia

Keywords

Protein intake, Muscle damage, Nutritional intervention, Supplements, e-health

Brief 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. 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.

Interventions

DIETARY_SUPPLEMENTmixed plant-based protein supplement

Daily dosage of the supplements will be 30 gram, preferably consumed in the morning and post-exercise or prior to sleep.

DIETARY_SUPPLEMENTwhey protein supplement

Daily dosage of the supplements will be 30 gram, preferably consumed in the morning and post-exercise or prior to sleep.

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).

DIETARY_SUPPLEMENTisocaloric carbohydrate control

Daily dosage of the supplements will be 30 gram, preferably consumed in the morning and post-exercise or prior to sleep.

Sponsors

Cosun
CollaboratorUNKNOWN
Radboud University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Masking description

The study consists of 4 arms of which 3 arms that receive a supplement and 1 arm that will use an e-health application to enhance protein intake. The 3 supplement arms are double-blind. The e-health arm is not; since it is not possible to blind either the participants in this group neither the investigators.

Intervention model description

4-arm intervention study

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
serum creatine kinase (CK) levelsMeasured 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.

Secondary

MeasureTime frameDescription
serum lactate dehydrogenase (LDH) levelsMeasured 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) cell damage. Non-fasted venous blood samples will be drawn from the antecubital vein at each pre-exercise and post-exercise visit.
muscle sorenessMeasured 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 is measured via the the Numeric Pain Scale (from 0 to 10, a higher score means more muscle soreness.
muscle functionMeasured 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)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.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026