Back to resultsProtein Quality to Support Increased Muscle Protein Synthesis
Primary Purpose
Sarcopenia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Protein Supplementation
Sponsored by
About this trial
This is an interventional prevention trial for Sarcopenia focused on measuring Sarcopenia, Muscle, Aging, Muscle Protein Synthesis
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Ivor Wynne Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Whey Protein Supplement
Pea Protein Supplement
Collagen Protein Supplement
Arm Description
Supplements will be consumed twice daily (25g per serving x 2 servings/day)
Supplements will be consumed twice daily (25g per serving x 2 servings/day)
Supplements will be consumed twice daily (25g per serving x 2 servings/day)
Outcomes
Primary Outcome Measures
Integrated Muscle Protein Synthesis
Integrated protein synthesis will be determined during 7 days of consuming the RDA of protein (control phase), and during 7 days of supplementation with a randomised protein supplement (Supplement phase).
Integrated rates of muscle protein synthesis (MPS) will be determined using the D2O method. Briefly, 2H enrichment of saliva (precursor) and muscle (product) pools (relative to 1H) will be determined using isotope ratio mass spectrometry and 'myofibrillar fractional synthetic rate' (%/day) determined.
Secondary Outcome Measures
Anabolic Signalling Proteins
The effect of each protein supplement on anabolic signalling proteins 1h post-ingestion.
Briefly, the phosphorylation status (activation) of anabolic signalling proteins will be determined by western blot analysis, and the fold change from that basal state will be presented.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04026607
Brief Title
Protein Quality to Support Increased Muscle Protein Synthesis
Official Title
Efficacy of Higher Versus Lower Quality Protein Supplementation to Support Increased Muscle Protein Synthesis in Older Men
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
January 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 have advocated that older persons should increase their daily intake to ~1.2 g/kg/d to support the preservation of muscle mass. The use of plant-based proteins in food formulation has recently become of interest. This study will examine the impact of consuming higher- versus lower-quality protein supplements on muscle protein synthesis in healthy older men.
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 consume dietary protein at the RDA for the entire duration of the protocol (2 weeks). Participants will be randomized to consuming collagen (control - CON), whey (WHEY), or pea (PEA) protein supplements twice daily for one week. We will examine the ability of different qualities of protein supplements to stimulate integrated rates of muscle protein synthesis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
Sarcopenia, Muscle, Aging, Muscle Protein Synthesis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will be a double blind, randomized parallel group controlled trial.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Participants and the investigators will be blinded to the supplement type, only the Lead Principal Investigator will have the codes to decipher the supplement type. Supplements are referred to as A, B and C.
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Whey Protein Supplement
Arm Type
Experimental
Arm Description
Supplements will be consumed twice daily (25g per serving x 2 servings/day)
Arm Title
Pea Protein Supplement
Arm Type
Experimental
Arm Description
Supplements will be consumed twice daily (25g per serving x 2 servings/day)
Arm Title
Collagen Protein Supplement
Arm Type
Experimental
Arm Description
Supplements will be consumed twice daily (25g per serving x 2 servings/day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein Supplementation
Intervention Description
Participants will continue to ingest the standardized diet; however, supplements will be consumed twice daily (25g per serving x 2 servings/day or 50g supplemental protein/day)
Primary Outcome Measure Information:
Title
Integrated Muscle Protein Synthesis
Description
Integrated protein synthesis will be determined during 7 days of consuming the RDA of protein (control phase), and during 7 days of supplementation with a randomised protein supplement (Supplement phase).
Integrated rates of muscle protein synthesis (MPS) will be determined using the D2O method. Briefly, 2H enrichment of saliva (precursor) and muscle (product) pools (relative to 1H) will be determined using isotope ratio mass spectrometry and 'myofibrillar fractional synthetic rate' (%/day) determined.
Time Frame
7 days x 2
Secondary Outcome Measure Information:
Title
Anabolic Signalling Proteins
Description
The effect of each protein supplement on anabolic signalling proteins 1h post-ingestion.
Briefly, the phosphorylation status (activation) of anabolic signalling proteins will be determined by western blot analysis, and the fold change from that basal state will be presented.
Time Frame
1 hour
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Phillips, Ph.D.
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ivor Wynne Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4L8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Protein Quality to Support Increased Muscle Protein Synthesis
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