Protein Intake and Exercise-induced Muscle Damage (PROMO)

Radboud University Medical Center

Status: Active, not recruiting

Conditions: Sarcopenia

Treatments: Other: e-health application; Dietary Supplement: mixed plant-based protein supplement; Dietary Supplement: isocaloric carbohydrate control; Dietary Supplement: whey protein supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT06235476

86007.091.23

Details and patient eligibility

About

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.

Enrollment: 199 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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199 participants in 4 patient groups

animal-based protein (WP)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: whey protein supplement

plant-based protein (MPP)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: mixed plant-based protein supplement

protein-rich food products (PFP)

Experimental group

Description:

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.

Treatment:

Other: e-health application

control (CON)

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: isocaloric carbohydrate control