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Completed

NCT Number: NCT06235476

Protein Intake and Exercise-induced Muscle Damage

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.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboudumc

Nijmegen, Gelderland, 6525GC, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Whey Protein Supplement

Dietary 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 supplement

Dietary Supplement

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

e-health application

Other

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 control

Dietary Supplement

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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) cell damage. Non-fasted venous blood samples will be drawn from the antecubital vein at each pre-exercise and post-exercise visit.

  2. 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 soreness is measured via the the Numeric Pain Scale (from 0 to 10, a higher score means more muscle soreness.

  3. 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)

    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.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Cosun

Registry information

Official study title

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

Acronym: PROMO

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 1, 2024
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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