Nutrition, HealthyNCT05917223
The Impact of Plant-based Blends on Skeletal Muscle Protein Synthesis Rates in Older Adults
A study testing Milk protein ingestion, Cron protein ingestion and Corn+Pea protein ingestion in people with Nutrition, Healthy, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- What is being tested?
- Milk protein ingestion, Cron protein ingestion and Corn+Pea protein ingestion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2023to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Nutrition, Healthy
- Being tested
- Milk protein ingestion, Cron protein ingestion, Corn+Pea protein ingestion, Non-protein, low energy
- Keywords
- Plant-based protein, Protein quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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+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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Milk protein ingestion | Experimental | Consuming 20 g of Milk Protein dissolved in 350mL of water, one time at the experiment visit Receives: 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 Receives: 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 Receives: 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 Receives: Dietary Supplement: Non-protein, low energy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle protein synthesis rate
The rate of amino acids incorporation into skeletal muscle protein
Measured: Over 5 hours after intervention
Secondary outcomes (4)
Plasma amino acid concentration
Amino acid content in plasma after ingestion of the supplements
Measured: Over 5 hours after intervention
Muscle anabolic protein signaling
Protein signaling changes in skeletal muscle tissue
Measured: At pre and 5 hours after intervention
Plasma glucose
Glucose content in plasma
Measured: Over 5 hours after intervention
Plasma insulin
Insulin content in plasma
Measured: Over 5 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start1 Jul 2023
- Primary completion30 Jun 2024
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is double-blind, placebo-controlled, randomized parallel control trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuart Phillips, McMaster University
- Investigators
- Stuart Phillips, Ph.D., Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917223
- Sponsor's protocol ID
- 16408
- Status last verified
- Oct 2024
- First submitted
- 11 Jun 2023
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lim C, Lees MJ, Janssen TAH, McKendry J, Smith C, Ho M, Sutoski A, Wu Y, Greaves E, da Costa FP, Varanan M, Goessens JPB, Senden JM, Loon LJCV, Phillips SM. Corn protein alone, or in blends, stimulates muscle protein synthesis comparable to milk protein, with or without resistance exercise, in older adults. J Nutr. 2026 Oct 26:101895. doi: 10.1016/j.tjnut.2026.101895. Online ahead of print.
PubMed 42933646
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Plant-based Protein Blends, With or Without Resistance Exercise, on Skeletal Muscle Protein Synthesis Rates in Older Men and Women
- ClinicalTrials.gov ID
- NCT05917223
- Acronym / sponsor ID
- 16408
- Conditions
- Nutrition, Healthy
- Keywords
- Plant-based protein, Protein quality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- This study is double-blind, placebo-controlled, randomized parallel control trial
| Arm | Type | Receives |
|---|---|---|
| Milk protein ingestion | Experimental | Dietary Supplement: Milk protein ingestionConsuming 20 g of Milk Protein dissolved in 350mL of water, one time at the experiment visit |
| Corn protein ingestion | Experimental | Dietary Supplement: Cron protein ingestionConsuming 20 g of Corn protein isolation dissolved in 350mL of water, one time at the experimental visit |
| Corn+Pea protein ingestion | Experimental | Dietary Supplement: Corn+Pea protein ingestionConsuming 20 g of Corn+Pea protein isolation dissolved in 350mL of water, one time at the experimental visit |
| Non-protein, low energy | Experimental | Dietary Supplement: Non-protein, low energyConsuming 20 g of carbohydrate dissolved in 350mL of water, one time at the experimental visit |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Milk protein ingestionIt'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. | Dietary supplement | Milk protein ingestion |
| Cron protein ingestionIt'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. | Dietary supplement | Corn protein ingestion |
| Corn+Pea protein ingestionIt'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. | Dietary supplement | Corn+Pea protein ingestion |
| Non-protein, low energyIt'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. | Dietary supplement | Non-protein, low energy |
Primary outcome
Muscle protein synthesis rate
Time frame: Over 5 hours after intervention
The rate of amino acids incorporation into skeletal muscle protein
4 secondary outcomes
Plasma amino acid concentration
Time frame: Over 5 hours after intervention
Muscle anabolic protein signaling
Time frame: At pre and 5 hours after intervention
Plasma glucose
Time frame: Over 5 hours after intervention
Plasma insulin
Time frame: Over 5 hours after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Derived from this study: PubMed 42933646Lim C, Lees MJ, Janssen TAH, McKendry J, Smith C, Ho M, Sutoski A, Wu Y, Greaves E, da Costa FP, Varanan M, Goessens JPB, Senden JM, Loon LJCV, Phillips SM. Corn protein alone, or in blends, stimulates muscle protein synthesis comparable to milk protein, with or without resistance exercise, in older adults. J Nutr. 2026 Oct 26:101895. doi: 10.1016/j.tjnut.2026.101895. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart Phillips, Ph.D. principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk protein ingestion, Cron protein ingestion and Corn+Pea protein ingestion in people with Nutrition, Healthy, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle protein synthesis rate (time frame: Over 5 hours after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05917223, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.