- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05369026
Effect of a Natural Source Supplementation on Muscle Mass
May 5, 2022 updated by: Stuart Phillips, McMaster University
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8S 4K1
- Exercise Metabolism Research Laboratory, McMaster Univeristy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 25 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fortetropin
Foretetropin, which is non-thermal pasteurized, freeze-dried fertilized egg yolk, per day
|
2 weeks of single-leg immobilization
|
Placebo Comparator: Placebo
Cheese powder, which is isonitrogenous, isoenergetic, and macronutrient-matched with Fortetropin
|
2 weeks of single-leg immobilization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline (Day 0), pre-immobilization (Day 14), post-immobilization (Day 28), post-recovery (Day 42)
|
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
|
Baseline (Day 0), pre-immobilization (Day 14), post-immobilization (Day 28), post-recovery (Day 42)
|
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.
|
Baseline (Day 0), pre-immobilization (Day 14), post-immobilization (Day 28), post-recovery (Day 42)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Myostatin level in plasma
Time Frame: Baseline (Day 0) and Post-recovery (Day 42)
|
Changes in Myostatin circulation level in plasma.
|
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)
|
Changes in isometric muscle strength using Biodex
|
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)
|
Changes in Basic metabolic panel and liver enzyme (ALT and AST) in plasma
|
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)
|
Changes in the number of myostatin positive satellite cells.
|
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)
|
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.
|
Pre-immobilization (Day 14), post-immobilization (Day 28), post-recovery (Day 42)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2020
Primary Completion (Actual)
March 25, 2022
Study Completion (Actual)
March 25, 2022
Study Registration Dates
First Submitted
May 3, 2022
First Submitted That Met QC Criteria
May 5, 2022
First Posted (Actual)
May 11, 2022
Study Record Updates
Last Update Posted (Actual)
May 11, 2022
Last Update Submitted That Met QC Criteria
May 5, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7935
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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