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Protein Intake and Exercise-induced Muscle Damage (PROMO)

R

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

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

Trial contacts and locations

1

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Central trial contact

Maartje Heijmans, MSc; Lotte Koopmans, MSc

Data sourced from clinicaltrials.gov

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