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

NCT ID: NCT05814705

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2025-04-30

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.

Conditions

Healthy; Muscle Disuse Atrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Protein supplement

Group Type: ACTIVE_COMPARATOR

Protein supplement

Intervention Type: DIETARY_SUPPLEMENT

Ready-to-drink protein beverage consumed once daily for 28 days

Protein supplement with Urolithin A

Group Type: EXPERIMENTAL

Protein supplement with Urolithin A

Intervention Type: DIETARY_SUPPLEMENT

Ready-to-drink protein beverage with 1000 mg of Urolithin A consumed once daily for 28 days

Interventions

Protein supplement

Ready-to-drink protein beverage consumed once daily for 28 days

Intervention Type: DIETARY_SUPPLEMENT

Protein supplement with Urolithin A

Ready-to-drink protein beverage with 1000 mg of Urolithin A consumed once daily for 28 days

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Stuart Phillips

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stuart Phillips

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

McMaster University

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

ISRCTN20052152

Identifier Type: REGISTRY

Identifier Source: secondary_id

13783

Identifier Type: -

Identifier Source: org_study_id