Clinical trial NCT06235476: Protein Intake and Exercise-induced Muscle Damage
Official title: Comparing the Effects of Three PROtein-enhancement Strategies on Exercise-induced Muscle Damage in Older Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sarcopenia
Keywords: Protein intake
Muscle damage
Nutritional intervention
Supplements
e-health
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Cosun
First posted: 2024-02-01
Enrollment: 199
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4-arm intervention study
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: serum creatine kinase (CK) levels
timeFrame: 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:
measure: serum lactate dehydrogenase (LDH) levels
timeFrame: 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)
measure: muscle soreness
timeFrame: 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)
measure: muscle function
timeFrame: 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)
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Maria Hopman, prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: