Status:
ACTIVE_NOT_RECRUITING
Protein Quantity and Quality in Older Subjects
Lead Sponsor:
McMaster University
Collaborating Sponsors:
National Dairy Council
Dairy Farmers of Canada
Conditions:
Aging
Eligibility:
All Genders
65-80 years
Phase:
NA
Brief Summary
After the age of \~50, humans start to lose muscle mass at a rate of about 1-3% per year. However, the loss of muscle mass beyond a certain point can make it increasingly difficult to perform activiti...
Eligibility Criteria
Inclusion
- Be a male or female, between the ages of 65 - 80 years (inclusive)
- Be willing and able to provide informed consent
- Be in general good health, non-smoking
- Have a body mass index (BMI) between 20-35 kg/m2 (inclusive)
Exclusion
- Use of tobacco or related products.
- 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 diets.
- 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 a clotting disorder or deep vein thrombosis;
- 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.
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05301179
Start Date
July 1 2021
End Date
April 30 2025
Last Update
October 2 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Exercise Metabolism Research Laboratory, McMaster Univeristy
Hamilton, Ontario, Canada, L8S 4K1