Muscle Disuse AtrophyNCT05369026
Effect of a Natural Source Supplementation on Muscle Mass
A study testing Single leg immobilization in people with Muscle Disuse Atrophy and Nutrition, Healthy, run by McMaster University at 1 site in Canada.
Trial summary
Periods of muscle disuse are commonly experienced in young and elderly individuals as a result of short-term hospitalization or leg casting after injury. Periods of immobilization result in a profound loss of muscle mass and strength. Read more about this study
- Who is it for?
- Ages 20 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Disuse Atrophy, Nutrition, Healthy
- What is being tested?
- Single leg immobilization
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2020to 25 Mar 2022
- 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 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men, between the ages of 20-25 years (inclusive).
- Willing and able to provide informed consent.
- Be in general good health, non-smoking.
- Body mass index (BMI) between 20-35kg/m2.
- Agree to not consume eggs for the duration of the study.
Who cannot join
- Use of tobacco related products.
- Veganism or vegetarianism.
- 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.
Show all 14Show fewer
- Current illness with could interfere with the study (e.g. prolonged severe diarrhea, regurgitation, difficulty swallowing).
- 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 standard drinks/week, e.g. 18oz glass of 5% beer - 1.5 standard drinks, a 750ml bottle of 12% wine = 5 standard drinks).
- Known sensitivity or allergy to amino acids or any ingredient in the test formulations. 12) Prior gastrointestinal bypass surgery (Lapband, etc.), irritable bowel disease or irritable bowel syndrome.
- History of bleeding diathesis, platelet or coagulation disorders, or antiplatelet/anti-coagulation therapy (up to 81 mg 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Exercise Metabolism Research Laboratory, McMaster Univeristy
Hamilton, Ontario, L8S 4K1
About this study
Official title: Effect of Fortetropin Supplementation in Young Men During Muscle Disuse
Periods of muscle disuse are commonly experienced in young and elderly individuals as a result of short-term hospitalization or leg casting after injury. Periods of immobilization result in a profound loss of muscle mass and strength. This loss of muscle mass can have negative effects on health and the ability to carry out activities of daily living. Thus, it is very important to try to maintain muscle mass during muscle disuse. Recent research suggests that Fortetropin, which is an all-natural protein-fat complex made from fertilized hen egg yolks, can enhance muscle mass and strength with weightlifting in young men. In this study, we aim to investigate the safety and tolerability of Fortetropin and whether Fortetropin supplementation can reduce or prevent the loss of muscle mass during single-leg immobilization while you are wearing a knee brace. To make this decision, we require a study to compare Fortetropin to a placebo (something that contains the same amount of protein and energy as Fortetropin). The findings from this study will help us understand if Fortetropin supplementation is safe, tolerable, and can be used to slow muscle loss in people who undergo periods of muscle disuse (i.e. surgery, sickness).
- Conditions
- Muscle Disuse Atrophy, Nutrition, Healthy
- Being tested
- Single leg immobilization
- Keywords
- Skeletal muscle, Supplementation, Disuse, Single-leg immobilization
- 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.
Single leg immobilizationOther
2 weeks of single-leg immobilization
| Study group | Role | What they receive |
|---|---|---|
| Fortetropin | Experimental | Foretetropin, which is non-thermal pasteurized, freeze-dried fertilized egg yolk, per day Receives: Other: Single leg immobilization |
| Placebo | Placebo comparator | Cheese powder, which is isonitrogenous, isoenergetic, and macronutrient-matched with Fortetropin Receives: Other: Single leg immobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vastus lateralis cross sectional area
Changes in vastus lateralis cross sectional area (CSA) by ultrasonography.
Measured: Baseline (Day 0), pre-immobilization (Day 14), post-immobilization (Day 28), post-recovery (Day 42)
Single fiber cross sectional area
Fiber type dependent single fiber CSA analyzed by immunohistochemistry
Measured: Baseline (Day 0), pre-immobilization (Day 14), post-immobilization (Day 28), post-recovery (Day 42)
Fat-and-bone free-mass
Fat-and-bone free-mass using DXA.
Measured: Baseline (Day 0), pre-immobilization (Day 14), post-immobilization (Day 28), post-recovery (Day 42)
Secondary outcomes (5)
Myostatin level in plasma
Changes in Myostatin circulation level in plasma.
Measured: Baseline (Day 0) and Post-recovery (Day 42)
Leg strength
Changes in isometric muscle strength using Biodex
Measured: Baseline (Day 0), pre-immobilization (Day 14), post-immobilization (Day 28), post-recovery (Day 42)
Basic metabolic panel and liver enzyme
Changes in Basic metabolic panel and liver enzyme (ALT and AST) in plasma
Measured: Baseline (Day 0), post-recovery (Day 42)
Myostatin positive satellite cells
Changes in the number of myostatin positive satellite cells.
Measured: Baseline (Day 0), pre-immobilization (Day 14), post-immobilization (Day 28), post-recovery (Day 42)
Gastrointestinal response to ingestion of the supplement
Assessment of gastrointestinal response to ingestion of the supplement using Likert scale questionnaire. The minimum (best) value is 1 and maximum (worst) value is 10.
Measured: Pre-immobilization (Day 14), post-immobilization (Day 28), post-recovery (Day 42)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start1 Jan 2020
- Primary completion25 Mar 2022
- Study completion25 Mar 2022
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 Disuse 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Myos Corporation
- Responsible party
- Principal investigator, Stuart Phillips, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369026
- Sponsor's protocol ID
- 7935
- Status last verified
- May 2022
- First submitted
- 3 May 2022
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lim C, McKendry J, Giacomin T, Mcleod JC, Ng SY, Currier BS, Coletta G, Phillips SM. Fortetropin supplementation prevents the rise in circulating myostatin but not disuse-induced muscle atrophy in young men with limb immobilization: A randomized controlled trial. PLoS One. 2023 May 23;18(5):e0286222. doi: 10.1371/journal.pone.0286222. eCollection 2023.
PubMed 37220119
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fortetropin Supplementation in Young Men During Muscle Disuse
- ClinicalTrials.gov ID
- NCT05369026
- Acronym / sponsor ID
- 7935
- Conditions
- Muscle Disuse Atrophy, Nutrition, Healthy
- Keywords
- Skeletal muscle, Supplementation, Disuse, Single-leg immobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Myos Corporation
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 11 May 2022 (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.
Periods of muscle disuse are commonly experienced in young and elderly individuals as a result of short-term hospitalization or leg casting after injury. Periods of immobilization result in a profound loss of muscle mass and strength. This loss of muscle mass can have negative effects on health and the ability to carry out activities of daily living. Thus, it is very important to try to maintain muscle mass during muscle disuse. Recent research suggests that Fortetropin, which is an all-natural protein-fat complex made from fertilized hen egg yolks, can enhance muscle mass and strength with weightlifting in young men. In this study, we aim to investigate the safety and tolerability of Fortetropin and whether Fortetropin supplementation can reduce or prevent the loss of muscle mass during single-leg immobilization while you are wearing a knee brace. To make this decision, we require a study to compare Fortetropin to a placebo (something that contains the same amount of protein and energy as Fortetropin). The findings from this study will help us understand if Fortetropin supplementation is safe, tolerable, and can be used to slow muscle loss in people who undergo periods of muscle disuse (i.e. surgery, sickness).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fortetropin | Experimental | Other: Single leg immobilizationForetetropin, which is non-thermal pasteurized, freeze-dried fertilized egg yolk, per day |
| Placebo | Placebo comparator | Other: Single leg immobilizationCheese powder, which is isonitrogenous, isoenergetic, and macronutrient-matched with Fortetropin |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men, between the ages of 20-25 years (inclusive).
- Willing and able to provide informed consent.
- Be in general good health, non-smoking.
- Body mass index (BMI) between 20-35kg/m2.
- Agree to not consume eggs for the duration of the study.
Key exclusion criteria (14 listed)
- Use of tobacco related products.
- Veganism or vegetarianism.
- 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.
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 |
|---|---|---|
| Single leg immobilization2 weeks of single-leg immobilization | Other | Fortetropin, Placebo |
Primary outcome
Vastus lateralis cross sectional area
Time frame: Baseline (Day 0), pre-immobilization (Day 14), post-immobilization (Day 28), post-recovery (Day 42)
Changes in vastus lateralis cross sectional area (CSA) by ultrasonography.
Single fiber cross sectional area
Time frame: Baseline (Day 0), pre-immobilization (Day 14), post-immobilization (Day 28), post-recovery (Day 42)
Fiber type dependent single fiber CSA analyzed by immunohistochemistry
Fat-and-bone free-mass
Time frame: Baseline (Day 0), pre-immobilization (Day 14), post-immobilization (Day 28), post-recovery (Day 42)
Fat-and-bone free-mass using DXA.
5 secondary outcomes
Myostatin level in plasma
Time frame: Baseline (Day 0) and Post-recovery (Day 42)
Leg strength
Time frame: Baseline (Day 0), pre-immobilization (Day 14), post-immobilization (Day 28), post-recovery (Day 42)
Basic metabolic panel and liver enzyme
Time frame: Baseline (Day 0), post-recovery (Day 42)
Myostatin positive satellite cells
Time frame: Baseline (Day 0), pre-immobilization (Day 14), post-immobilization (Day 28), post-recovery (Day 42)
Gastrointestinal response to ingestion of the supplement
Time frame: Pre-immobilization (Day 14), post-immobilization (Day 28), post-recovery (Day 42)
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 11 May 2022.
- Derived from this study: PubMed 37220119Lim C, McKendry J, Giacomin T, Mcleod JC, Ng SY, Currier BS, Coletta G, Phillips SM. Fortetropin supplementation prevents the rise in circulating myostatin but not disuse-induced muscle atrophy in young men with limb immobilization: A randomized controlled trial. PLoS One. 2023 May 23;18(5):e0286222. doi: 10.1371/journal.pone.0286222. eCollection 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single leg immobilization in people with Muscle Disuse Atrophy and Nutrition, Healthy, 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 5 inclusion and 14 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 11 May 2022. 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?
Vastus lateralis cross sectional area (time frame: Baseline (Day 0), pre-immobilization (Day 14), post-immobilization (Day 28), post-recovery (Day 42)). The study lists 3 primary outcomes in all. 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 NCT05369026, 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 11 May 2022.