NCT05814705

The Effects of Protein Supplementation With or Without Urolithin A During Single-leg Immobilization

Comparison of High-protein Formulation With/Without Urolithin a During a Unilateral Knee Immobilization: a Pilot Proof-of-concept Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: McMaster University · Academic / Other
• Sex: Male
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

Summary

There are times in life when people cannot use their muscles, such as during illness or injury. Muscle and mitochondria (the 'energy factory' in cells) health decline very quickly when people cannot use their muscles, but certain foods can help reduce these declines. Recent research suggests that Urolithin A, which is a natural compound that can be produced after eating pomegranates, nuts, and berries, improves muscle health. In this study, the investigators aim to investigate if a protein beverage (standard care during disuse) with or without Urolithin A can reduce or prevent the loss of muscle health while wearing a knee brace (muscle disuse).

Detailed description

After participants provide informed consent to participate and are deemed eligible for the study (Day 0), participants will sequentially complete the three phases of this study: 1. RUN-IN phase: participants continue habitual lifestyle (Day 7-Day 14 \[1 week\]) 2. IMMOBILIZATION phase: participants undergo 2 weeks of unilateral knee immobilization (Day 14-Day 28 \[2 weeks\]) 3. RECOVERY phase: participants return to habitual lifestyle (Day 28-Day 35 \[1 week\]) Participants will consume their randomly assigned supplement daily during all three phases.

Conditions

• Healthy
• Muscle Disuse Atrophy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Protein supplement	Ready-to-drink protein beverage consumed once daily for 28 days
DIETARY_SUPPLEMENT	Protein supplement with Urolithin A	Ready-to-drink protein beverage with 1000 mg of Urolithin A consumed once daily for 28 days

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-05-31
• Completion: 2025-04-30
• First posted: 2023-04-18
• Last updated: 2024-10-02

Locations

1 site across 1 country: Canada