Protein Quality to Support Increased Muscle Protein Synthesis

Sponsor
McMaster University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04026607
Collaborator
(none)
45
1
3
16
2.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Protein Supplementation
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The study will be a double blind, randomized parallel group controlled trial.The study will be a double blind, randomized parallel group controlled trial.
Masking:
Triple (Participant, Investigator, Outcomes 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.
Primary Purpose:
Prevention
Official Title:
Efficacy of Higher Versus Lower Quality Protein Supplementation to Support Increased Muscle Protein Synthesis in Older Men
Actual Study Start Date :
Dec 1, 2019
Anticipated Primary Completion Date :
Dec 31, 2020
Anticipated Study Completion Date :
Mar 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Whey Protein Supplement

Supplements will be consumed twice daily (25g per serving x 2 servings/day)

Dietary Supplement: Protein Supplementation
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)

Experimental: Pea Protein Supplement

Supplements will be consumed twice daily (25g per serving x 2 servings/day)

Dietary Supplement: Protein Supplementation
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)

Experimental: Collagen Protein Supplement

Supplements will be consumed twice daily (25g per serving x 2 servings/day)

Dietary Supplement: Protein Supplementation
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)

Outcome Measures

Primary Outcome Measures

  1. Integrated Muscle Protein Synthesis [7 days x 2]

    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

  1. Anabolic Signalling Proteins [1 hour]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 80 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Men, between the ages of 65 - 80 years (inclusive)

  2. Willing and able to provide informed consent

  3. Be in general good health, non-smoking

  4. Have a body mass index (BMI) between 20-38 kg/m2 (inclusive)

Exclusion Criteria:
  1. Use of tobacco or related products.

  2. Veganism or vegetarianism

  3. 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.

  4. Use assistive walking devices (e.g., cane or walker)

  5. 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.

  6. 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.

  7. 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

  8. Current illnesses which could interfere with the study (e.g. prolonged severe diarrhea, regurgitation, difficulty swallowing)

  9. Hypersensitivity or known allergy to any of the components in the test formulations.

  10. Excessive alcohol consumption (>21 units/week)

  11. 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).

  12. History of statin myalgia.

  13. Personal or family history of clotting disorder or deep vein thrombosis;

  14. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ivor Wynne Centre Hamilton Ontario Canada L8S 4L8

Sponsors and Collaborators

  • McMaster University

Investigators

  • Principal Investigator: Stuart Phillips, Ph.D., McMaster University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stuart Phillips, Professor, McMaster University
ClinicalTrials.gov Identifier:
NCT04026607
Other Study ID Numbers:
  • 7360
First Posted:
Jul 19, 2019
Last Update Posted:
Feb 5, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Stuart Phillips, Professor, McMaster University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 5, 2020