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NCT Number: NCT05814705

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University

Hamilton, Ontario, Canada

About this study

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:

  • RUN-IN phase: participants continue habitual lifestyle (Day 7-Day 14 [1 week])
  • IMMOBILIZATION phase: participants undergo 2 weeks of unilateral knee immobilization (Day 14-Day 28 [2 weeks])
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Protein Supplement

Dietary Supplement

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

Protein supplement with Urolithin A

Dietary Supplement

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

Primary outcomes

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

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

    Oxygen flux in muscle measured using Oroboros

Secondary outcomes

  1. Muscle strength (Biodex)

    Time frame: Day 7, Day 14, Day 28, Day 35

    Isometric leg extension strength

  2. Quadriceps muscle size

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

    Muscle size measured using MRI

  3. Muscle protein fractional synthetic rate

    Time frame: 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

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Apr 18, 2023
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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