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

Sponsor
McMaster University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05917223
Collaborator
(none)
48
1
4
14
3.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Milk protein ingestion
  • Dietary Supplement: Cron protein ingestion
  • Dietary Supplement: Corn+Pea protein ingestion
  • Dietary Supplement: Non-protein, low energy
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This study is double-blind, placebo-controlled, randomized parallel control trialThis study is double-blind, placebo-controlled, randomized parallel control trial
Masking:
Double (Participant, Investigator)
Masking Description:
This study is double-blind, placebo-controlled, randomized parallel control trial
Primary Purpose:
Treatment
Official Title:
The Impact of Plant-based Protein Blends, With or Without Resistance Exercise, on Skeletal Muscle Protein Synthesis Rates in Older and Women
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Aug 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Milk protein ingestion

Consuming 20 g of Milk Protein dissolved in 350mL of water, one time at the experiment visit

Dietary Supplement: Milk protein ingestion
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.

Experimental: Corn protein ingestion

Consuming 20 g of Corn protein isolation dissolved in 350mL of water, one time at the experimental visit

Dietary Supplement: Cron protein ingestion
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.

Experimental: Corn+Pea protein ingestion

Consuming 20 g of Corn+Pea protein isolation dissolved in 350mL of water, one time at the experimental visit

Dietary Supplement: Corn+Pea protein ingestion
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.

Experimental: Non-protein, low energy

Consuming 20 g of carbohydrate dissolved in 350mL of water, one time at the experimental visit

Dietary Supplement: Non-protein, low energy
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.

Outcome Measures

Primary Outcome Measures

  1. Muscle protein synthesis rate [Over 5 hours after intervention]

    The rate of amino acids incorporation into skeletal muscle protein

Secondary Outcome Measures

  1. Plasma amino acid concentration [Over 5 hours after intervention]

    Amino acid content in plasma after ingestion of the supplements

  2. Muscle anabolic protein signaling [At pre and 5 hours after intervention]

    Protein signaling changes in skeletal muscle tissue

  3. Plasma glucose [Over 5 hours after intervention]

    Glucose content in plasma

  4. Plasma insulin [Over 5 hours after intervention]

    Insulin content in plasma

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

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:
NCT05917223
Other Study ID Numbers:
  • 16408
First Posted:
Jun 23, 2023
Last Update Posted:
Jun 27, 2023
Last Verified:
Jun 1, 2023
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 Jun 27, 2023