Protein Quality to Support Increased Muscle Protein Synthesis

NCT04026607 | Completed

• 1 other identifier: 7360
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Keywords

Sarcopenia; Muscle; Aging; Muscle Protein Synthesis

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days x 2

Secondary Outcomes (1)

• Anabolic Signalling Proteins

  1 hour

Study Arms (3)

Whey Protein Supplement

EXPERIMENTAL

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

Dietary Supplement: Protein Supplementation

Pea Protein Supplement

EXPERIMENTAL

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

Dietary Supplement: Protein Supplementation

Collagen Protein Supplement

EXPERIMENTAL

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

Dietary Supplement: Protein Supplementation

Interventions

Protein Supplementation 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; Pea Protein Supplement; Whey Protein Supplement

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

Ivor Wynne Centre

Hamilton, Ontario, L8S 4L8, Canada

Location

Related Publications (1)

• 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.

  PMID: 38762187 DERIVED

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Stuart Phillips, Ph.D.

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The study will be a double blind, randomized parallel group controlled trial.

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 19, 2019
• Study Start: December 1, 2019
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: April 20, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)