- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05917223
The Impact of Plant-based Blends on Skeletal Muscle Protein Synthesis Rates in Older Adults
The Impact of Plant-based Protein Blends, With or Without Resistance Exercise, on Skeletal Muscle Protein Synthesis Rates in Older Men and Women
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8S 4L8
- Ivor Wynne Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Milk protein ingestion
Consuming 20 g of Milk Protein dissolved in 350mL of water, one time at the experiment visit
|
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
|
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
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle protein synthesis rate
Time Frame: Over 5 hours after intervention
|
The rate of amino acids incorporation into skeletal muscle protein
|
Over 5 hours after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plasma amino acid concentration
Time Frame: Over 5 hours after intervention
|
Amino acid content in plasma after ingestion of the supplements
|
Over 5 hours after intervention
|
|
Muscle anabolic protein signaling
Time Frame: At pre and 5 hours after intervention
|
Protein signaling changes in skeletal muscle tissue
|
At pre and 5 hours after intervention
|
|
Plasma glucose
Time Frame: Over 5 hours after intervention
|
Glucose content in plasma
|
Over 5 hours after intervention
|
|
Plasma insulin
Time Frame: Over 5 hours after intervention
|
Insulin content in plasma
|
Over 5 hours after intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stuart Phillips, Ph.D., McMaster University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16408
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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