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

Primary Purpose

Healthy, Muscle Disuse Atrophy

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Protein supplement
Protein supplement with Urolithin A
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

  • McMaster UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Protein supplement

Protein supplement with Urolithin A

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Muscle strength (Biodex)
Isometric leg extension strength
Quadriceps muscle size
Muscle size measured using MRI
Muscle protein fractional synthetic rate
Protein synthetic rate using labelled alanine incorporation

Full Information

First Posted
March 10, 2023
Last Updated
October 18, 2023
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT05814705
Brief Title
The Effects of Protein Supplementation With or Without Urolithin A During Single-leg Immobilization
Official Title
Comparison of High-protein Formulation With/Without Urolithin a During a Unilateral Knee Immobilization: a Pilot Proof-of-concept Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Muscle Disuse Atrophy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Protein supplement
Arm Type
Active Comparator
Arm Title
Protein supplement with Urolithin A
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein supplement
Intervention Description
Ready-to-drink protein beverage consumed once daily for 28 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein supplement with Urolithin A
Intervention Description
Ready-to-drink protein beverage with 1000 mg of Urolithin A consumed once daily for 28 days
Primary Outcome Measure Information:
Title
Change in maximal mitochondrial respiration (rate of oxygen flux) and mitochondrial ADP [adenosine diphosphate] sensitivity (Oroboros O2k)
Description
Oxygen flux in muscle measured using Oroboros
Time Frame
Outcome measured and reported for: Day 7, Day 14, Day 28, Day 35
Secondary Outcome Measure Information:
Title
Muscle strength (Biodex)
Description
Isometric leg extension strength
Time Frame
Day 7, Day 14, Day 28, Day 35
Title
Quadriceps muscle size
Description
Muscle size measured using MRI
Time Frame
Outcome measured and reported for: Day 14, Day 28, Day 35
Title
Muscle protein fractional synthetic rate
Description
Protein synthetic rate using labelled alanine incorporation
Time Frame
Day 7, Day 14, Day 28, Day 35; integrated synthesis rates reported for Day 7-14, Day 14-28; Day 28-35

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brad Currier
Phone
9055259140
Email
currierb@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Phillips
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brad Currier
Phone
9055259140
Email
currierb@mcmaster.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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