HealthyNCT05814705
The Effects of Protein Supplementation With or Without Urolithin A During Single-leg Immobilization
A study testing Protein supplement and Protein supplement with Urolithin A in people with Healthy and Muscle Disuse Atrophy, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Muscle Disuse Atrophy
- What is being tested?
- Protein supplement and Protein supplement with Urolithin A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2023to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of High-protein Formulation With/Without Urolithin a During a Unilateral Knee Immobilization: a Pilot Proof-of-concept Trial
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).
Read the 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.
- Conditions
- Healthy, Muscle Disuse Atrophy
- Being tested
- Protein supplement, Protein supplement with Urolithin A
- Medical subject headings
- Muscular Disorders, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein supplementDietary supplement
Ready-to-drink protein beverage consumed once daily for 28 days
Protein supplement with Urolithin ADietary supplement
Ready-to-drink protein beverage with 1000 mg of Urolithin A consumed once daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Protein supplement | Active comparator | Not described Receives: Dietary Supplement: Protein supplement |
| Protein supplement with Urolithin A | Experimental | Not described Receives: Dietary Supplement: Protein supplement with Urolithin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximal mitochondrial respiration (rate of oxygen flux) and mitochondrial ADP [adenosine diphosphate] sensitivity (Oroboros O2k)
Oxygen flux in muscle measured using Oroboros
Measured: Outcome measured and reported for: Day 7, Day 14, Day 28, Day 35
Secondary outcomes (3)
Muscle strength (Biodex)
Isometric leg extension strength
Measured: Day 7, Day 14, Day 28, Day 35
Quadriceps muscle size
Muscle size measured using MRI
Measured: Outcome measured and reported for: Day 14, Day 28, Day 35
Muscle protein fractional synthetic rate
Protein synthetic rate using labelled alanine incorporation
Measured: Day 7, Day 14, Day 28, Day 35; integrated synthesis rates reported for Day 7-14, Day 14-28; Day 28-35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Jun 2023
- Primary completion31 May 2024
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuart Phillips, McMaster University
- Investigators
- Stuart Phillips, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814705
- Sponsor's protocol ID
- 13783
- Other IDs
- ISRCTN20052152
- Status last verified
- Oct 2024
- First submitted
- 10 Mar 2023
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of High-protein Formulation With/Without Urolithin a During a Unilateral Knee Immobilization: a Pilot Proof-of-concept Trial
- ClinicalTrials.gov ID
- NCT05814705
- Acronym / sponsor ID
- 13783
- Conditions
- Healthy, Muscle Disuse Atrophy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protein supplement | Active comparator | Dietary Supplement: Protein supplement |
| Protein supplement with Urolithin A | Experimental | Dietary Supplement: Protein supplement with Urolithin A |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein supplementReady-to-drink protein beverage consumed once daily for 28 days | Dietary supplement | Protein supplement |
| Protein supplement with Urolithin AReady-to-drink protein beverage with 1000 mg of Urolithin A consumed once daily for 28 days | Dietary supplement | Protein supplement with Urolithin A |
Primary outcome
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
3 secondary outcomes
Muscle strength (Biodex)
Time frame: Day 7, Day 14, Day 28, Day 35
Quadriceps muscle size
Time frame: Outcome measured and reported for: Day 14, Day 28, Day 35
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart Phillips principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein supplement and Protein supplement with Urolithin A in people with Healthy and Muscle Disuse Atrophy, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.