Clinical trial NCT05301179: Protein Quantity and Quality in Older Subjects
Official title: The Mechanistic Underpinning of Protein Quality and Quantity in Aging Skeletal Muscle: A High Sensitivity Dynamic Proteome Profiling Approach
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aging
Keywords: protein
plant-based
dairy
aging
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: National Dairy Council
name: Dairy Farmers of Canada
First posted: 2022-03-29
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: In a partial factorial cross-over design, subjects will be assigned to one of two protein daily intakes and complete two different levels of dietary protein quality.
Primary purpose: BASIC_SCIENCE

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 activities of daily living such as rising from a chair, going up and downstairs, carrying groceries, etc. A reason why muscle mass is lost with age is that skeletal muscles become less sensitive to the growth-promoting effects of physical activity and protein ingestion. This loss of sensitivity can be overcome by consuming larger amounts of protein; however, many older adults have difficulties simply consuming greater amounts of protein from whole-food sources. Therefore, the research in this study aims to investigate how different amounts and types of protein, of either a 100%-plant-based or Lacto-vegetarian (plant-based plus dairy) protein sources, affect muscle growth. This information will be important when providing information to older adults about the amount and type of protein that should be consumed by older adults to help prevent the loss of muscle mass that typically occurs with advancing age.


Eligibility criteria: Inclusion Criteria:

1. Be a male or female, between the ages of 65 - 80 years (inclusive)
2. Be willing and able to provide informed consent
3. Be in general good health, non-smoking
4. Have a body mass index (BMI) between 20-35 kg/m2 (inclusive)

Exclusion Criteria:

1. Use of tobacco or related products.
2. 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.
3. Use assistive walking devices (e.g., cane or walker)
4. 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.
5. 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.
6. 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
7. Current illnesses which could interfere with the study (e.g. prolonged severe diarrhea, regurgitation, difficulty swallowing)
8. Hypersensitivity or known allergy to any of the components in the diets.
9. Excessive alcohol consumption (\>21 units/week)
10. 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).
11. History of statin myalgia.
12. Personal or family history of a clotting disorder or deep vein thrombosis;
13. 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.

Primary outcomes:
measure: Dynamic proteome profiling (synthesis and breakdown)
timeFrame: Resulting data after two weeks following a vegan and a lacto-vegetarian diet
measure: Integrated muscle protein synthesis
timeFrame: Integrated total protein synthesis after two weeks following a vegan and a lacto-vegetarian diet
measure: Whole-body protein balance
timeFrame: After two weeks on an experimental diet, whole body protein balance will be measured during a day visit to the lab
Secondary outcomes:
measure: Cell signaling pathways regulating protein synthesis in skeletal muscle
timeFrame: Acute - Fed response (2h after ingestion of a test meal - this will be measured twice during the study - the response to a vegan meal and a to lacto-vegetarian meal).
measure: Daily plasma amino acid concentration
timeFrame: One day in response to 3 main meals (twice during the study - 1 day ingesting vegan meals and another day ingesting lacto-vegetarian meals)
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Exercise Metabolism Research Laboratory, McMaster Univeristy
state: Ontario
Study officials:
affiliation: McMaster University, Department of Kinesiology
name: Stuart Phillips, PhD
role: PRINCIPAL_INVESTIGATOR
References: