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

NCT05814705 | Active Not Recruiting

• 2 other identifiers: 13783ISRCTN20052152
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy; Muscle Disuse Atrophy

Outcome Measures

Primary Outcomes (1)

• Change in maximal mitochondrial respiration (rate of oxygen flux) and mitochondrial ADP [adenosine diphosphate] sensitivity (Oroboros O2k)

  Oxygen flux in muscle measured using Oroboros

  Outcome measured and reported for: Day 7, Day 14, Day 28, Day 35

Secondary Outcomes (3)

• Muscle strength (Biodex)

  Day 7, Day 14, Day 28, Day 35

• Quadriceps muscle size

  Outcome measured and reported for: Day 14, Day 28, Day 35

• 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

Study Arms (2)

Protein supplement

ACTIVE COMPARATOR

Dietary Supplement: Protein supplement

Protein supplement with Urolithin A

EXPERIMENTAL

Dietary Supplement: Protein supplement with Urolithin A

Interventions

Protein supplement DIETARY_SUPPLEMENT

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

Protein supplement

Protein supplement with Urolithin A DIETARY_SUPPLEMENT

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

Protein supplement with Urolithin A

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men aged 18-30 years
• Healthy, non-smoking
• BMI between 20 and 30 kg/m\^2
• No orthopedic issues that would preclude participation in the knee bracing protocol
• 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
• Provide informed consent
• 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

You may not qualify if:

• 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
• Clinically significant abnormal laboratory results at screening
• Participation in a clinical research trial within 30 days before randomization
• Allergy or sensitivity to study ingredients
• Individuals who are cognitively impaired and/or who are unable to give informed consent
• 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
• Any cachexia-related condition or any genetic muscle diseases or disorders
• 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.)
• Excessive alcohol consumption (\>21 units/week) and/or a smoker (cigarettes or vaping)
• 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
• Contraindications to an MRI scan (metal implants, metal-based ink tattoo)

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, Canada

Location

MeSH Terms

Conditions

Muscular Disorders, Atrophic

Interventions

3,8-dihydroxy-6H-dibenzo(b,d)pyran-6-one

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Stuart Phillips

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: April 18, 2023
• Study Start: June 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: April 30, 2025
• Last Updated: October 2, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)