NCT05917223

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

October 3, 2024

Status Verified

October 1, 2024

Enrollment Period

1 year

First QC Date

June 11, 2023

Last Update Submit

October 1, 2024

Conditions

Keywords

Plant-based protein, Protein quality

Outcome Measures

Primary Outcomes (1)

  • Muscle protein synthesis rate

    The rate of amino acids incorporation into skeletal muscle protein

    Over 5 hours after intervention

Secondary Outcomes (4)

  • Plasma amino acid concentration

    Over 5 hours after intervention

  • Muscle anabolic protein signaling

    At pre and 5 hours after intervention

  • Plasma glucose

    Over 5 hours after intervention

  • Plasma insulin

    Over 5 hours after intervention

Study Arms (4)

Milk protein ingestion

EXPERIMENTAL

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

Dietary Supplement: Milk protein ingestion

Corn protein ingestion

EXPERIMENTAL

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

Dietary Supplement: Cron protein ingestion

Corn+Pea protein ingestion

EXPERIMENTAL

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

Non-protein, low energy

EXPERIMENTAL

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

Dietary Supplement: Non-protein, low energy

Interventions

Milk protein ingestionDIETARY_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.

Milk protein ingestion
Cron protein ingestionDIETARY_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 protein ingestion
Corn+Pea protein ingestionDIETARY_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.

Corn+Pea protein ingestion
Non-protein, low energyDIETARY_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.

Non-protein, low energy

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ivor Wynne Centre

Hamilton, Ontario, L8S 4L8, Canada

Location

Study Officials

  • Stuart Phillips, Ph.D.

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
This study is double-blind, placebo-controlled, randomized parallel control trial
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study is double-blind, placebo-controlled, randomized parallel control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 11, 2023

First Posted

June 23, 2023

Study Start

July 1, 2023

Primary Completion

June 30, 2024

Study Completion

May 31, 2025

Last Updated

October 3, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations