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

• Sponsor: McMaster University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05814705
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 16
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Healthy; Muscle Disuse Atrophy	Dietary Supplement: Protein supplement; Dietary Supplement: Protein supplement with Urolithin A	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Comparison of High-protein Formulation With/Without Urolithin a During a Unilateral Knee Immobilization: a Pilot Proof-of-concept Trial
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: May 31, 2024
• Anticipated Study Completion Date: Sep 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Protein supplement	Dietary Supplement: Protein supplement; Ready-to-drink protein beverage consumed once daily for 28 days
Experimental: Protein supplement with Urolithin A	Dietary Supplement: Protein supplement with Urolithin A; Ready-to-drink protein beverage with 1000 mg of Urolithin A consumed once daily for 28 days

Outcome Measures

Primary Outcome Measures

1. Change in maximal mitochondrial respiration (rate of oxygen flux) and mitochondrial ADP [adenosine diphosphate] sensitivity (Oroboros O2k) [Outcome measured and reported for: Day 7, Day 14, Day 28, Day 35]

   Oxygen flux in muscle measured using Oroboros

Secondary Outcome Measures

1. Muscle strength (Biodex) [Day 7, Day 14, Day 28, Day 35]

   Isometric leg extension strength

2. Quadriceps muscle size [Outcome measured and reported for: Day 14, Day 28, Day 35]

   Muscle size measured using MRI

3. Muscle protein fractional synthetic rate [Day 7, Day 14, Day 28, Day 35; integrated synthesis rates reported for Day 7-14, Day 14-28; Day 28-35]

   Protein synthetic rate using labelled alanine incorporation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 30 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Men aged 18-30 years

2. Healthy, non-smoking

3. BMI between 20 and 30 kg/m^2

4. No orthopedic issues that would preclude participation in the knee bracing protocol

5. Not taking any medication or with any medical condition that, in the opinion of the investigators, would compromise the study outcome or the safety of the research participant

6. Provide informed consent

7. Understand COVID-19 risks and procedures for in person research and sign Information Letter: COVID-19 Risks and Procedures for In-Person Research at McMaster University

Exclusion Criteria:

1. Subject has any concurrent medical, orthopedic, or psychiatric requirements that, in the opinion of the investigators, would compromise their ability to comply with the study requirements

2. Clinically significant abnormal laboratory results at screening

3. Participation in a clinical research trial within 30 days before randomization

4. Allergy or sensitivity to study ingredients

5. Individuals who are cognitively impaired and/or who are unable to give informed consent

6. Any other condition that, in the opinion of the investigators, may adversely affect the subject's ability to complete the study or its measures or may pose a significant risk to the subject

7. Any cachexia-related condition or any genetic muscle diseases or disorders

8. Current gastrointestinal condition that could interfere with the study (e.g., IBS/IBD [irritable bowel syndrome/inflammatory bowel disease], diarrhea, acid reflux disease, dysphagia, etc.)

9. Excessive alcohol consumption (>21 units/week) and/or a smoker (cigarettes or vaping)

10. Concomitant use of corticosteroids, antibiotics, any anabolic steroid, creatine, whey protein supplements, casein, branched-chain amino acids (BCAAs) or any other NHP [Natural Health Product], medication or supplement used for muscle strengthening/building within 45 days prior to screening

11. Contraindications to an MRI scan (metal implants, metal-based ink tattoo)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	McMaster University	Hamilton	Ontario	Canada

Sponsors and Collaborators

• McMaster University

Investigators

• Principal Investigator: Stuart Phillips, McMaster University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stuart Phillips, Professor, McMaster University
• ClinicalTrials.gov Identifier: NCT05814705
• Other Study ID Numbers: 13783; ISRCTN20052152
• First Posted: Apr 18, 2023
• Last Update Posted: Apr 18, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Muscular Disorders, Atrophic

Study Results

No Results Posted as of Apr 18, 2023