Protein Intake and Exercise-induced Muscle Damage

Sarcopenia Clinical Trial

— PROMO  

Official title:

Comparing the Effects of Three PROtein-enhancement Strategies on Exercise-induced Muscle Damage in Older Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06235476
• Other study ID #: 86007.091.23
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: December 2023
• Source: Radboud University Medical Center
• Contact: Maartje Heijmans, MSc
• Phone: +31646556186
• Email: maartje.heijmans[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: August 31, 2024
• Est. primary completion date: July 19, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Dietary Supplement:
• whey protein supplement
Daily dosage of the supplements will be 30 gram, preferably consumed in the morning and post-exercise or prior to sleep.
• 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.

Other:
• 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).

Dietary Supplement:
• isocaloric carbohydrate control
Daily dosage of the supplements will be 30 gram, preferably consumed in the morning and post-exercise or prior to sleep.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University Medical Center	Cosun

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum creatine kinase (CK) levels	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.	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	serum lactate dehydrogenase (LDH) levels	(Muscle) cell damage. Non-fasted venous blood samples will be drawn from the antecubital vein at each pre-exercise and post-exercise visit.	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	muscle soreness	Muscle soreness is measured via the the Numeric Pain Scale (from 0 to 10, a higher score means more muscle soreness.	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	muscle function	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.	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)