Muscle AtrophyNCT03267745
Effects of Amino Acid Formulation on Healthy Men Undergoing Unilateral Knee Immobilization
A study testing Amino Acid and Breg Brace single-leg immobilization in people with Muscle Atrophy, run by McMaster University at 1 site in Canada.
Trial summary
This is a safety and tolerability study investigating the effect of an amino acid formulation in healthy volunteers during and after limb immobilization. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Atrophy
- What is being tested?
- Amino Acid and Breg Brace single-leg immobilization
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 30 Aug 2017to 1 Aug 2018
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally healthy, non-smoking
- Willing and able to provide informed consent
- Men age 20-45 years
- BMI between 25 and 35 kg/m2
Who cannot join
- Smoker;
- Subject has any concurrent medical, orthopedic, or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements;
- History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years;
- Significant orthopedic, cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder (requiring ongoing medical care), or metabolic/endocrine disorder (e.g., diabetes, high cholesterol, elevated fasting blood sugar) or other disease that would preclude oral protein supplement ingestion and/or assessment of safety and study objectives;
- Any cachexia-related condition (e.g., relating to cancer, tuberculosis or human immunodeficiency virus infection and acquired immune deficiency syndrome) or any genetic muscle diseases or disorders;
- Current illnesses which could interfere with the study (e.g. prolonged severe diarrhea, regurgitation, difficulty swallowing);
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- Subject participated in a study of an investigational product less than 60 days or 5 half-lives of the investigational product, whichever is longer, before enrollment in this study;
- Hypersensitivity to any of the components of the test product;
- Excessive alcohol consumption (>21 units/week); (> 21 standard drinks/wk); e.g., 18oz glass of 5% beer - 1.5 standard drinks, a 750 mL bottle of 12% wine = 5 standard drinks.
- Known sensitivity or allergy to amino acids or any ingredient in the test formulations;
- Prior gastrointestinal bypass surgery (Lapband, etc.), irritable bowel disease or irritable bowel syndrome;
- History of bleeding diathesis, platelet or coagulation disorders, or antiplatelet/anticoagulation therapy (up to 81mg of baby aspirin per day taken as a prophylactic is permitted);
- Personal or family history of clotting disorder or deep vein thrombosis. Deep vein thrombosis is a serious, and potentially lethal, medical condition, therefore, it is imperative if you have personal or family history it is disclosed this to the research staff.
- Concomitant use of corticosteroids, testosterone replacement therapy (ingestion, injection, or transdermal), any anabolic steroid, creatine, whey protein supplements, casein or branched-chain amino acids (BCAAs) within 45 days prior to Screening;
- Contraindications to an MRI scan (e.g. subjects with non-removable ferromagnetic implants, pacemakers, aneurysm clips or other foreign bodies, or subjects with claustrophobic symptoms that would contraindicate an MRI scan).
- Hemoglobin <11.5mg/dl at Screening;
- Platelets <150,000/uL (150x109/L) at Screening.
Trial locations and contacts
1 site in 1 country.
About this study
This is a safety and tolerability study investigating the effect of an amino acid formulation in healthy volunteers during and after limb immobilization.
- Conditions
- Muscle Atrophy
- Being tested
- Amino Acid, Breg Brace single-leg immobilization, Placebo
- Keywords
- protein, skeletal muscle, immobilization
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino AcidDietary supplement
23.7 g amino acid 3 times daily for 28 days
Breg Brace single-leg immobilizationDevice
Also called Breg brace
7 days of single leg immobilization; randomized to leg; knee brace will be worn in a fixed flexion position at 140°.
PlaceboOther
Excipient-matched placebo 3 times daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Amino Acid | Experimental | Subjects in this arm will receive amino acid supplementation (23.7g) 3 times daily for 28 days. Amino acids will be provided in powder form to be dissolved in 8oz of water. Participants will also undergo single-leg immobilization (Breg brace) for 7 days (days 8-15) during the 28 day study period. Receives: Dietary Supplement: Amino Acid; Device: Breg Brace single-leg immobilization |
| Placebo | Placebo comparator | Subjects in this arm will receive placebo 3 times daily for 28 days. Placebo will consist of 23.7g of excipient-matched placebo in water. Participants will also undergo single-leg immobilization (Breg brace) for 7 days (days 8-15) during the 28 day study period. Receives: Device: Breg Brace single-leg immobilization; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle atrophy
To determine the impact of an amino acid formulation on muscle atrophy after 7 days of amino acid supplementation followed by 7 days of single leg immobilization and 14 days of recovery post-immobilization muscle atrophy will be assessed utilizing percutaneous muscle biopsy to quantify fibre size in the vastus lateralis.
Measured: day 0, day 8, day 15 and day 28
Secondary outcomes (2)
Change in muscle strength
Strength will be measured using a Biodex.
Measured: day 0, day 8, day 15 and day 28
Change in muscle size
Muscle size will be assessed via MRI.
Measured: day 0, day 8, day 15 and day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start30 Aug 2017
- Primary completion19 Dec 2017
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle AtrophyStudies 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
- Model description
- 2 groups of 10 each will be randomized to receive amino acid supplementation or placebo for 28 days during which they will have one leg immobilized by a removable brace.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Axcella Health, Inc
- Responsible party
- Sponsor
- Investigators
- Stuart M Phillips, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267745
- Sponsor's protocol ID
- 3365
- Status last verified
- Jun 2019
- First submitted
- 9 Aug 2017
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holloway TM, McGlory C, McKellar S, Morgan A, Hamill M, Afeyan R, Comb W, Confer S, Zhao P, Hinton M, Kubassova O, Chakravarthy MV, Phillips SM. A Novel Amino Acid Composition Ameliorates Short-Term Muscle Disuse Atrophy in Healthy Young Men. Front Nutr. 2019 Jul 10;6:105. doi: 10.3389/fnut.2019.00105. eCollection 2019.
PubMed 31355205
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Amino Acid Formulation on Healthy Men Undergoing Unilateral Knee Immobilization
- ClinicalTrials.gov ID
- NCT03267745
- Acronym / sponsor ID
- 3365
- Conditions
- Muscle Atrophy
- Keywords
- protein, skeletal muscle, immobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Axcella Health, Inc
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- 19 Dec 2017 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 30 Aug 2017 (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.
This is a safety and tolerability study investigating the effect of an amino acid formulation in healthy volunteers during and after limb immobilization.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 groups of 10 each will be randomized to receive amino acid supplementation or placebo for 28 days during which they will have one leg immobilized by a removable brace.
| Arm | Type | Receives |
|---|---|---|
| Amino Acid | Experimental | Dietary Supplement: Amino Acid, Device: Breg Brace single-leg immobilizationSubjects in this arm will receive amino acid supplementation (23.7g) 3 times daily for 28 days. Amino acids will be provided in powder form to be dissolved in 8oz of water. Participants will also undergo single-leg immobilization (Breg brace) for 7 days (days 8-15) during the 28 day study period. |
| Placebo | Placebo comparator | Device: Breg Brace single-leg immobilization, Other: PlaceboSubjects in this arm will receive placebo 3 times daily for 28 days. Placebo will consist of 23.7g of excipient-matched placebo in water. Participants will also undergo single-leg immobilization (Breg brace) for 7 days (days 8-15) during the 28 day study period. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Generally healthy, non-smoking
- Willing and able to provide informed consent
- Men age 20-45 years
- BMI between 25 and 35 kg/m2
Key exclusion criteria (17 listed)
- Smoker;
- Subject has any concurrent medical, orthopedic, or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements;
- History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years;
- Significant orthopedic, cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder (requiring ongoing medical care), or metabolic/endocrine disorder (e.g., diabetes, high cholesterol, elevated fasting blood sugar) or other disease that would preclude oral protein supplement ingestion and/or assessment of safety and study objectives;
- Any cachexia-related condition (e.g., relating to cancer, tuberculosis or human immunodeficiency virus infection and acquired immune deficiency syndrome) or any genetic muscle diseases or disorders;
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 |
|---|---|---|
| Amino Acid23.7 g amino acid 3 times daily for 28 days | Dietary supplement | Amino Acid |
| Breg Brace single-leg immobilizationAlso: Breg brace7 days of single leg immobilization; randomized to leg; knee brace will be worn in a fixed flexion position at 140°. | Device | Amino Acid, Placebo |
| PlaceboExcipient-matched placebo 3 times daily for 28 days | Other | Placebo |
Primary outcome
Change in muscle atrophy
Time frame: day 0, day 8, day 15 and day 28
To determine the impact of an amino acid formulation on muscle atrophy after 7 days of amino acid supplementation followed by 7 days of single leg immobilization and 14 days of recovery post-immobilization muscle atrophy will be assessed utilizing percutaneous muscle biopsy to quantify fibre size in the vastus lateralis.
2 secondary outcomes
Change in muscle strength
Time frame: day 0, day 8, day 15 and day 28
Change in muscle size
Time frame: day 0, day 8, day 15 and day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
- Derived from this study: PubMed 31355205Holloway TM, McGlory C, McKellar S, Morgan A, Hamill M, Afeyan R, Comb W, Confer S, Zhao P, Hinton M, Kubassova O, Chakravarthy MV, Phillips SM. A Novel Amino Acid Composition Ameliorates Short-Term Muscle Disuse Atrophy in Healthy Young Men. Front Nutr. 2019 Jul 10;6:105. doi: 10.3389/fnut.2019.00105. eCollection 2019.
- Individual participant dataSharing planned: No
Related trials for Muscle Atrophy
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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 M Phillips, PhD 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 Amino Acid and Breg Brace single-leg immobilization in people with Muscle 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 4 inclusion and 17 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: finished, as of the sponsor's last update on 19 Jun 2019. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 muscle atrophy (time frame: day 0, day 8, day 15 and day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03267745, which also lists 1 linked publication.
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 19 Jun 2019.