Status:

COMPLETED

Protein Quality to Support Increased Muscle Protein Synthesis

Lead Sponsor:

McMaster University

Conditions:

Sarcopenia

Eligibility:

MALE

65-80 years

Phase:

NA

Brief Summary

The age-related decline in muscle mass and strength is collectively referred to as sarcopenia. Canadian recommended daily allowance (RDA) for protein intake (0.8 g/kg/d), however, many expert groups h...

Detailed Description

This study will examine the impact of consuming higher- versus lower-quality protein supplements on the integrated rates of muscle protein synthesis in healthy older men. Briefly, participants will co...

Eligibility Criteria

Inclusion

  • Men, between the ages of 65 - 80 years (inclusive)
  • Willing and able to provide informed consent
  • Be in general good health, non-smoking
  • Have a body mass index (BMI) between 20-38 kg/m2 (inclusive)

Exclusion

  • Use of tobacco or related products.
  • Veganism or vegetarianism
  • 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.
  • Use assistive walking devices (e.g., cane or walker)
  • 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, or metabolic/endocrine disorders 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)
  • Hypersensitivity or known allergy to any of the components in the test formulations.
  • Excessive alcohol consumption (\>21 units/week)
  • 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).
  • History of statin myalgia.
  • Personal or family history of clotting disorder or deep vein thrombosis;
  • Routine/daily usage of non-steroidal anti-inflammatory drugs (NSAIDS, prescription use or daily use of over the counter medication), 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.

Key Trial Info

Start Date :

December 1 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 31 2023

Estimated Enrollment :

45 Patients enrolled

Trial Details

Trial ID

NCT04026607

Start Date

December 1 2019

End Date

January 31 2023

Last Update

April 20 2023

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Ivor Wynne Centre

Hamilton, Ontario, Canada, L8S 4L8