Skip to main content
OpenTrials
Completed

NCT Number: NCT04026607

Protein Quality to Support Increased Muscle Protein Synthesis

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Ivor Wynne Centre

Hamilton, Ontario, L8S 4L8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Primary outcomes

  1. Integrated Muscle Protein Synthesis

    Time frame: 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 outcomes

  1. Anabolic Signalling Proteins

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

Efficacy of Higher Versus Lower Quality Protein Supplementation to Support Increased Muscle Protein Synthesis in Older Men

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 19, 2019
Registry last updated
Apr 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.