Protein Intake and Exercise-induced Muscle Damage (NCT06235476) | Clinical Trial Compass
CompletedNot Applicable
Protein Intake and Exercise-induced Muscle Damage
Netherlands199 participantsStarted 2024-06-10
Plain-language 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.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
serum creatine kinase (CK) levels
Timeframe: 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)