Protein Intake and Exercise-induced Muscle Damage

NCT ID: NCT06235476

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 199 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-10
• Study Completion Date: 2025-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

animal-based protein (WP)

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.

Group Type: EXPERIMENTAL

whey protein supplement

Intervention Type: 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)

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.

Group Type: EXPERIMENTAL

mixed plant-based protein supplement

Intervention Type: DIETARY_SUPPLEMENT

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

protein-rich food products (PFP)

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.

Group Type: EXPERIMENTAL

e-health application

Intervention Type: 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).

control (CON)

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.

Group Type: ACTIVE_COMPARATOR

isocaloric carbohydrate control

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

whey protein supplement

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

Intervention Type: DIETARY_SUPPLEMENT

mixed 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.

Intervention Type: DIETARY_SUPPLEMENT

e-health application

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).

Intervention Type: OTHER

isocaloric carbohydrate control

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cosun

UNKNOWN

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Hopman, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Radboudumc

Nijmegen, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

86007.091.23

Identifier Type: -

Identifier Source: org_study_id