Protein Intake and Exercise-induced Muscle Damage

Not Applicable

Active, not recruiting

• Conditions: Sarcopenia

• Registration Number: NCT06235476
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-21
• Study First Submitted QC: 2024-01-29
• Study First Posted: 2024-02-01
• Study Start: 2024-06-10
• Primary Completion: 2024-07-19
• Status Verified: 2024-08
• Last Update Submitted: 2025-07-22
• Last Update Posted: 2025-07-24
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 199

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
serum creatine kinase (CK) levels	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 Outcome Measures

Name	Time	Method
muscle soreness	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.
muscle function	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.
serum lactate dehydrogenase (LDH) levels	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.

Trial Locations

Locations (1)

Radboudumc; 🇳🇱 Nijmegen, Gelderland, Netherlands