Pea Protein and Muscle Mass During Weight Loss

September 3, 2025 updated by: Dr. Peter Zahradka, University of Manitoba

A Pilot Study to Examine the Effect of Pea Protein on Limiting the Loss of Muscle Mass During Weight Loss

A pilot study comparing the effects of pea protein versus whey protein on the preservation of muscle mass and functionality in individuals undertaking a weight loss regimen.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A single site, double-blind, randomized clinical trial designed to compare the effects of pea protein or whey protein or maltodextrin supplementation on muscle mass and functionality in males and females with obesity undertaking a weight loss regimen. Eligible participants will be randomized to one of the three groups (pea protein, whey protein, maltodextrin) and will be asked to attend 3 in-person clinic visits (0, 6, and 12 weeks) for blood and urine collection and assessments of muscle mass and muscle function. A separate visit for screening and for a fasting blood sample, as well as a Pre-Study visit and a meeting with a registered dietitian, will be required.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Carla G Taylor, PhD
  • Phone Number: 204-258-1361
  • Email: ctaylor@sbrc.ca

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • I.H Asper Clinical Research Institute, St. Boniface Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Male, or non-pregnant, non-lactating female, 30 to 50 years of age;
  2. BMI >30 and body weight does not exceed the capacity of the DEXA (350 lbs);
  3. Fat mass >23% for males and >32% for females (determined at the screening visit via bioelectrical impedance);
  4. Willing to maintain a stable level of activity while participating in the study;
  5. Plasma creatinine ≤265 µmol/L;
  6. Plasma LDL-cholesterol <5 mmol/L;
  7. Aspartate aminotransferase <160 U/L, and alanine aminotransferase <150 U/L;
  8. Glycated hemoglobin <6.5%;
  9. Blood pressure <160 mmHg systolic and <100 mmHg diastolic;
  10. Stable regime if taking vitamin and mineral/dietary/herbal supplements for the past 1 month and while participating in the study;
  11. Not taking protein supplements for the past month and willing to continue doing so for the duration of the study;
  12. Has not donated blood or blood products (e.g. platelets) during the past 2 months and willing to continue doing so while participating in the study;
  13. Female participants of child-bearing potential must agree to use a highly effective method of contraception throughout the study;
  14. Not participating in another dietary intervention trial for the past month and willing to not start another dietary intervention trial or weight loss program for the duration of this study;
  15. Willing to comply with the protocol requirements and procedures;
  16. Willing to provide informed consent.

Exclusion Criteria:

  1. Has experienced a cardiovascular event (e.g. heart attack, stroke) or had a surgical procedure for cardiovascular disease (e.g. bypass, stent), presence of diabetes, chronic renal disease, liver disease (with exception of fatty liver), rheumatoid arthritis, immune disorder or disease (e.g. multiple sclerosis, leukemia), cancer in the previous 5 years, neurological disorders, gastrointestinal disorders or gastrointestinal surgery or bariatric surgery, or liposuction;
  2. Taking medications for blood glucose management;
  3. Taking medications or natural health products/supplements associated with weight gain or weight loss (e.g. prednisone, certain cold medications);
  4. Body weight that has not been stable (± 5%) over the past 3 months;
  5. History of gastrointestinal reactions or allergies to peas, pea protein, whey protein or maltodextrin, or to one or more ingredients in the beverages and foods that will be provided which significantly limits the number of items that can be used for delivery of the protein powders or maltodextrin;
  6. Current (within the past 30 days) bacterial, viral or fungal infection;
  7. Uncontrolled hypothyroidism;
  8. Uncontrolled blood pressure;
  9. Bleeding disorder;
  10. Any acute medical condition or surgical intervention within the past 3 months;
  11. Cigarette/cigar smoking or use of tobacco products within the last 12 months or during participation in the study;
  12. Consumption of >10 alcoholic beverages per week or >2 alcoholic beverages per day within the last 3 months or while participating in the study;
  13. Drug and/or alcohol abuse;
  14. Psychological disorder(s);
  15. Unable to obtain blood sample at the screening or week 0 visits.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pea Protein
Participants will consume pea protein (0.35 grams protein/kg body weight/day) as a powder incorporated into foods or beverages at least twice per day for 12 weeks.
Other: Pea Protein
Soluble pea protein
Other Names:
  • NUTRALYS S85
Active Comparator: Whey Protein
Participants will consume whey protein (0.35 grams protein/kg body weight/day) as a powder incorporated into foods or beverages at least twice per day for 12 weeks.
Other: Whey Protein
Whey protein concentrate
Other Names:
  • Whey Protein Concentrate 80 Instant Kosher
Placebo Comparator: Maltodextrin
Participants will consume maltodextrin (isocaloric non-protein comparator) as a powder incorporated into foods or beverages at least twice per day for 12 weeks.
Other: Maltodextrin
Non-protein isocaloric comparator
Other Names:
  • GLUCIDEX 19

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in muscle mass
Time Frame: Baseline and 12 weeks
Muscle mass will be assessed by dual x-ray absorptiometry
Baseline and 12 weeks
Change in muscle function (hand grip)
Time Frame: Baseline and 12 weeks
A dynamometer will be used to measure hand grip strength
Baseline and 12 weeks
Change in muscle function (gait test)
Time Frame: Baseline and 12 weeks
A gait test will be performed
Baseline and 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in fat mass
Time Frame: Baseline and 12 weeks
Fat mass will be measured by dual x-ray absorptiometry
Baseline and 12 weeks
Change in body weight and body mass index
Time Frame: Baseline and 12 weeks
Body weight will be measured and used for calculation of body mass index
Baseline and 12 weeks
Change in waist and waist to height ratio
Time Frame: Baseline and 12 weeks
Waist circumferences will be measured and used for calculation of waist to height ratio
Baseline and 12 weeks
Change in resting energy expenditure
Time Frame: Baseline and 12 weeks
Resting energy expenditure will be measured by metabolic cart
Baseline and 12 weeks
Change in C-reactive protein
Time Frame: Baseline and 12 weeks
A fasting venous blood sample will be analyzed for C-reactive protein to assess inflammatory status
Baseline and 12 weeks
Change in homeostatic model for insulin resistance (HOMA-IR)
Time Frame: Baseline and 12 weeks
A fasting venous blood sample will be analyzed for insulin and glucose to calculate HOMA-IR using the formula fasting insulin x fasting glucose / 405
Baseline and 12 weeks
Change in glycated hemoglobin
Time Frame: Baseline and 12 weeks
A fasting venous blood sample will be analyzed for glycated hemoglobin
Baseline and 12 weeks
Change in blood lipid profile
Time Frame: Baseline and 12 weeks
A fasting venous blood sample will be analyzed for total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides as the blood lipid profile
Baseline and 12 weeks
Change in kidney function (based on profile of circulating markers)
Time Frame: Baseline and 12 weeks
A fasting venous blood sample will be analyzed for blood urea nitrogen and serum creatinine to obtain a profile of circulating markers for assessing kidney function
Baseline and 12 weeks
Change in kidney function (based on profile of urinary markers)
Time Frame: Baseline and 12 weeks
A spot urine sample will be analyzed for urine albumin, creatinine and urea to obtain a profile of urinary markers for assessing kidney function
Baseline and 12 weeks
Change in liver function (based on profile of circulating markers)
Time Frame: Baseline and 12 weeks
A fasting venous blood sample will be analyzed for plasma alanine aminotransferase and aspartate aminotransferase to obtain a profile of circulating markers for assessing liver function
Baseline and 12 weeks
Change in systolic and diastolic blood pressure
Time Frame: Baseline and 12 weeks
Systolic and diastolic blood pressure will be measured
Baseline and 12 weeks
Changes in blood vessel function
Time Frame: Baseline and 12 weeks
Pulse wave velocity measurements will obtained for assessment of arterial stiffness, an indicator of blood vessel function
Baseline and 12 weeks
24 h activity patterns over time
Time Frame: Up to 12 weeks
Participants will wear a Fitbit to monitor 24 hour activity patterns
Up to 12 weeks
Food intake over time
Time Frame: Up to 12 weeks
Participants will complete 3-Day Food Records at 3 week intervals for analysis of nutrient intake
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Manitoba

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter Zahradka, PhD, St. Boniface Hospital Albrechtsen Research Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 17, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 2, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 2, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 11, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HS22196

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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