Protein Quality to Support Increased Muscle Protein Synthesis

NCT ID: NCT04026607

Last Updated: 2023-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2023-01-31

Brief Summary

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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

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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.

Conditions

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Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will be a double blind, randomized parallel group controlled trial.
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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Whey Protein Supplement

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

Group Type EXPERIMENTAL

Protein Supplementation

Intervention Type DIETARY_SUPPLEMENT

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)

Pea Protein Supplement

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

Group Type EXPERIMENTAL

Protein Supplementation

Intervention Type DIETARY_SUPPLEMENT

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)

Collagen Protein Supplement

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

Group Type EXPERIMENTAL

Protein Supplementation

Intervention Type DIETARY_SUPPLEMENT

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)

Interventions

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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)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Stuart Phillips

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stuart Phillips, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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Ivor Wynne Centre

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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McKendry J, Lowisz CV, Nanthakumar A, MacDonald M, Lim C, Currier BS, Phillips SM. The effects of whey, pea, and collagen protein supplementation beyond the recommended dietary allowance on integrated myofibrillar protein synthetic rates in older males: a randomized controlled trial. Am J Clin Nutr. 2024 Jul;120(1):34-46. doi: 10.1016/j.ajcnut.2024.05.009. Epub 2024 May 16.

Reference Type DERIVED
PMID: 38762187 (View on PubMed)

Other Identifiers

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7360

Identifier Type: -

Identifier Source: org_study_id

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