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Protein Intake and Exercise-induced Muscle Damage

Not Applicable
Active, not recruiting
Conditions
Sarcopenia
Interventions
Other: e-health application
Dietary Supplement: whey protein supplement
Dietary Supplement: isocaloric carbohydrate control
Dietary Supplement: mixed plant-based protein supplement
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

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
Arm && Interventions
GroupInterventionDescription
protein-rich food products (PFP)e-health applicationPFP 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.
animal-based protein (WP)whey protein supplementSupplements 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.
control (CON)isocaloric carbohydrate controlSupplements 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.
plant-based protein (MPP)mixed plant-based protein supplementSupplements 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.
Primary Outcome Measures
NameTimeMethod
serum creatine kinase (CK) levelsMeasured 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
NameTimeMethod
muscle sorenessMeasured 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 functionMeasured 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) levelsMeasured 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

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