Protein Intake and Exercise-induced Muscle Damage

NCT06235476 | Completed DMC

• 1 other identifier: 86007.091.23
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 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

  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

  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

  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)

Study Arms (4)

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.

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.

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.

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.

Dietary Supplement: isocaloric carbohydrate control

Interventions

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.

animal-based protein (WP)

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.

plant-based protein (MPP)

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).

protein-rich food products (PFP)

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.

control (CON)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Cosun: collaborator

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6525GC, Netherlands

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

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

Study Officials

• Maria Hopman, prof. dr.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 4-arm intervention study

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: February 1, 2024
• Study Start: June 10, 2024
• Primary Completion: July 19, 2024
• Study Completion: July 31, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available after completion of the study and will be available for at least 15 years.
• Access Criteria: IPD will be shared with researchers within the department of Medical Biosciences of the Radboudumc. Data may be shared with other researchers upon request.

Locations

NL (1)