Effect of a Natural Source Supplementation on Muscle Mass

NCT05369026 | Completed

• 1 other identifier: 7935
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Skeletal muscle; Supplementation; Disuse; Single-leg immobilization

Outcome Measures

Primary Outcomes (3)

• Vastus lateralis cross sectional area

  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

  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

  Fat-and-bone free-mass using DXA.

  Baseline (Day 0), pre-immobilization (Day 14), post-immobilization (Day 28), post-recovery (Day 42)

Secondary Outcomes (5)

• Myostatin level in plasma

  Baseline (Day 0) and Post-recovery (Day 42)

• Leg strength

  Baseline (Day 0), pre-immobilization (Day 14), post-immobilization (Day 28), post-recovery (Day 42)

• Basic metabolic panel and liver enzyme

  Baseline (Day 0), post-recovery (Day 42)

• 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

  Pre-immobilization (Day 14), post-immobilization (Day 28), post-recovery (Day 42)

Study Arms (2)

Fortetropin

EXPERIMENTAL

Foretetropin, which is non-thermal pasteurized, freeze-dried fertilized egg yolk, per day

Other: Single leg immobilization

Placebo

PLACEBO COMPARATOR

Cheese powder, which is isonitrogenous, isoenergetic, and macronutrient-matched with Fortetropin

Other: Single leg immobilization

Interventions

Single leg immobilization OTHER

2 weeks of single-leg immobilization

Fortetropin; Placebo

Eligibility Criteria

• Age: 20 Years - 25 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead
• Myos Corporation: collaborator

Study Sites (1)

Exercise Metabolism Research Laboratory, McMaster Univeristy

Hamilton, Ontario, L8S 4K1, Canada

Location

Related Publications (1)

• 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.

  PMID: 37220119 DERIVED

MeSH Terms

Conditions

Muscular Disorders, Atrophic

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 11, 2022
• Study Start: January 1, 2020
• Primary Completion: March 25, 2022
• Study Completion: March 25, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)