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NCT Number: NCT05917223

The Impact of Plant-based Blends on Skeletal Muscle Protein Synthesis Rates in Older Adults

Lifestyle interventions such as physical activity and dietary habits are the most effective non-pharmacological strategies to combat the loss of muscle mass and the development of mobility limitations with aging. Resistance training (i.e., strengthening exercise) provides a strong stimulus to build muscle mass, and protein provides the essential building blocks. Therefore, an individual's dietary practices can influence the effectiveness of an exercise program - when combined, they work together to increase the muscle-building response. However, not all proteins are equally effective at bringing about muscle growth.

Therefore, the purpose of this study is to investigate the effect of a higher-quality plant-based protein blend with lifting weight on muscle building in older men and women.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ivor Wynne Centre

Hamilton, Ontario, L8S 4L8, Canada

About this study

Dietary interventions are similarly pertinent in preventing skeletal muscle mass losses with aging. Dietary protein ingestion provides the necessary substrates (i.e., amino acids) essential for skeletal muscle development, health, and, thus, maintenance of muscle mass. Protein ingestion and resistance exercise training (RET) increase muscle protein synthesis (MPS), but when combined, they act synergistically to maximize MPS. Importantly, not all protein sources are equivalent in their ability to support increased rates of MPS. A recent study confirmed that a blend of plant proteins at a large dose of 30 g resulted in similar MPS as 30g of milk protein in young men. However, the impact of a unique plant-derived protein blend on MPS in older individuals is yet to be determined. Therefore, the purpose of this study is to address that knowledge gap by assessing the skeletal muscle anabolic potential of a plant-based protein blend (i.e., corn and pea) on rates of MPS, with or without additive exercise in older men and women.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Older (60-80 y) men and women
  • Be in good general health
  • Non-smoking
  • Recreationally active but not meet Canada's Physical Activity Guidelines (150 min of moderate-intensity exercise/week)
  • Have a body mass index (BMI) between 18.5-30 kg/m2 (inclusive)
  • Willing and able to provide informed consent (speaks and understands English)

Exclusion criteria

  • Use of tobacco or related products
  • Use assistive walking devices (e.g., cane or walker)
  • 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
  • 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, metabolic/endocrine, neuromuscular or bone wasting disorders
  • 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
  • History of statin myalgia
  • Current illnesses which could interfere with the study (e.g., prolonged severe diarrhea, regurgitation, difficulty swallowing)
  • 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).
  • 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.
  • A history of falls determined by a score >25 on the Falls Efficacy Scale-International (FES-I).

Treatment and study plan

Milk protein ingestion

Dietary Supplement

It's just an acute intervention, so the participant assigned to the Milk protein ingestion group will consume 20 g of milk protein during infusion protocol.

Cron protein ingestion

Dietary Supplement

It's just an acute intervention, so the participant assigned to the Corn protein ingestion group will consume 20 g of corn protein isolation during infusion protocol.

Corn+Pea protein ingestion

Dietary Supplement

It's just an acute intervention, so the participant assigned to the Corn+Pea protein ingestion group will consume 20 g of Corn+Pea protein isolation during infusion protocol.

Non-protein, low energy

Dietary Supplement

It's just an acute intervention, so the participant assigned to the Non-protein, low energy group will consume 20 g of carbohydrate during infusion protocol.

Primary outcomes

  1. Muscle protein synthesis rate

    Time frame: Over 5 hours after intervention

    The rate of amino acids incorporation into skeletal muscle protein

Secondary outcomes

  1. Plasma amino acid concentration

    Time frame: Over 5 hours after intervention

    Amino acid content in plasma after ingestion of the supplements

  2. Muscle anabolic protein signaling

    Time frame: At pre and 5 hours after intervention

    Protein signaling changes in skeletal muscle tissue

  3. Plasma glucose

    Time frame: Over 5 hours after intervention

    Glucose content in plasma

  4. Plasma insulin

    Time frame: Over 5 hours after intervention

    Insulin content in plasma

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

The Impact of Plant-based Protein Blends, With or Without Resistance Exercise, on Skeletal Muscle Protein Synthesis Rates in Older Men and Women

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jun 23, 2023
Registry last updated
Oct 3, 2024

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.

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