Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-01-12 @ 2:48 AM
Study NCT ID:
NCT05814705
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-02
First Post:
2023-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Protein Supplementation With or Without Urolithin A During Single-leg Immobilization
Sponsor:
McMaster University
Organization:
Study Overview
Official Title:
Comparison of High-protein Formulation With/Without Urolithin a During a Unilateral Knee Immobilization: a Pilot Proof-of-concept Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ISRCTN20052152 | REGISTRY | International Standard Randomised Controlled Trial Number | View |