The effects of protein supplementation with or without Urolithin A during single-leg immobilization
| ISRCTN | ISRCTN20052152 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20052152 |
| ClinicalTrials.gov number | NCT05814705 |
| Secondary identifying numbers | 13783 |
- Submission date
- 08/02/2023
- Registration date
- 09/02/2023
- Last edited
- 28/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
There are times in life when we cannot use our muscles, such as during illness or injury. Muscle and mitochondria (the ‘energy factory’ in our cells) health decline very quickly when we cannot use our 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, we 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).
Who can participate?
We are recruiting healthy male volunteers aged 18-30 years.
What does the study involve?
This study involves consuming a randomly assigned supplement for 4 weeks, including 2 weeks of wearing a knee brace.
What are the possible benefits and risks of participating?
There are no proposed benefits to you as the subject of this study. However, the findings of this study may contribute to the development of nutritional interventions that prevent or attenuate the loss of skeletal muscle mass in various clinical scenarios including aging, bed rest, surgery, cachexia, and renal failure.
As with any research, there are risks of participating such as during blood sampling or muscle biopsies. The researcher team has done everything possible to mitigate any risks and will gladly provide further information if requested.
Where is the study run from?
McMaster University in Hamilton, Ontario, Canada
When is the study starting and how long is it expected to run for?
April 2021 to December 2023
Who is funding the study?
This study is funded by Nestle SA (Switzerland)
Who is the main contact?
Stuart Phillips, phillis@mcmaster.ca
Contact information
Scientific, Principal Investigator
1280 Main Street West
Department of Kinesiology
McMaster University
Hamilton
L8S 4K1
Canada
 ORCID ID |
0000-0002-1956-4098 |
|---|---|
| Phone | +1 (905) 525-9140 ext. 24465 |
| phillis@mcmaster.ca |
Study information
| Study design | Single-centre interventional double-blinded randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Laboratory, University/medical school/dental school |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Comparison of high-protein formulation with/without urolithin a during a unilateral knee immobilization: a pilot proof-of-concept trial |
| Study objectives | 1. PRO+UA will mitigate reductions in maximal mitochondrial respiration compared to PRO during immobilization. 2. PRO+UA will alter gene expression compared to PRO during immobilization. |
| Ethics approval(s) | Approved 30/11/2022, Hamilton Integrated Research Ethics Board (293 Wellington St. N., Suite 120 Hamilton, ON, Canada L8L 8E7; +1 905-521-2100 Ext. 42013; eREBhelpdesk@hhsc.ca), ref: #13783 |
| Health condition(s) or problem(s) studied | Disuse-induced muscle atrophy in healthy young adults |
| Intervention | Participants will be randomized (computer-generated) to either active comparator (protein) or treatment (protein plus Urolithin A) group. Participants will sequentially complete the three phases of this study: 1. RUN-IN phase – participants continue habitual lifestyle (1 week) 2. IMMOBILIZATION phase – participants undergo 2 weeks of unilateral knee immobilization 3. RECOVERY phase – participants return to habitual lifestyle (1 week) Measurements will be taken at baseline and the end of each phase. Participants will consume their randomly assigned beverage (ready-to-drink supplement; 20 grams of protein with or without 1000 mg Urolithin A) during all three phases. |
| Intervention type | Supplement |
| Primary outcome measure | 1. Maximal mitochondrial respiration and mitochondrial ADP sensitivity (Oroboros O2k; measured at baseline and the end of each phase) 2. Gene expression (measured at baseline and the end of each phase) |
| Secondary outcome measures | 1. Skeletal muscle fractional synthetic rate (deuterated water; measured at baseline and the end of each phase) 2. Leg muscle strength (biodex dynamometer; measured at baseline and the end of each phase) 3. Quadriceps volume and cross-sectional area (magnetic resonance imaging; measured at baseline and the end of each phase) 4. Physical activity level (accelerometry; measured at baseline and the end of each phase) 5. Metabolomics (plasma; measured at baseline and the end of each phase) |
| Overall study start date | 01/04/2021 |
| Completion date | 01/12/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 30 Years |
| Sex | Male |
| Target number of participants | 24 |
| Total final enrolment | 24 |
| Key inclusion criteria | 1. Men aged 18-30 years 2. Healthy, non-smoking 3. BMI between 20 and 30 kg/m² 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 |
| Key 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, 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, 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) |
| Date of first enrolment | 24/02/2023 |
| Date of final enrolment | 01/04/2024 |
Locations
Countries of recruitment
- Canada
Study participating centre
Hamilton
L8S 4L8
Canada
Sponsor information
University/education
1280 Main Street West
Hamilton
L8S4K1
Canada
| Phone | +1 (905) 525-9140 |
|---|---|
| currierb@mcmaster.ca | |
| Website | http://www.mcmaster.ca/ |
"ROR" |
https://ror.org/02fa3aq29 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/05/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
28/02/2025: Contact details updated.
15/05/2024: The overall study end date was changed from 31/05/2024 to 01/12/2023.
17/04/2024: Total final enrolment added.
08/04/2024: ClinicalTrials.gov number added.
10/02/2023: Trial's existence confirmed by Hamilton Integrated Research Ethics Board.
