ObesityNCT04123938
Pea Protein and Muscle Mass During Weight Loss
A study testing Pea Protein, Whey Protein and Maltodextrin in people with Obesity, run by University of Manitoba at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Pea Protein, Whey Protein and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 17 Oct 2019to 2 May 2023
- 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male, or non-pregnant, non-lactating female, 30 to 50 years of age;
- BMI >30 and body weight does not exceed the capacity of the DEXA (350 lbs);
- Fat mass >23% for males and >32% for females (determined at the screening visit via bioelectrical impedance);
- Willing to maintain a stable level of activity while participating in the study;
- Plasma creatinine ≤265 µmol/L;
- Plasma LDL-cholesterol <5 mmol/L;
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- Aspartate aminotransferase <160 U/L, and alanine aminotransferase <150 U/L;
- Glycated hemoglobin <6.5%;
- Blood pressure <160 mmHg systolic and <100 mmHg diastolic;
- Stable regime if taking vitamin and mineral/dietary/herbal supplements for the past 1 month and while participating in the study;
- Not taking protein supplements for the past month and willing to continue doing so for the duration of the study;
- 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;
- Female participants of child-bearing potential must agree to use a highly effective method of contraception throughout the study;
- 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;
- Willing to comply with the protocol requirements and procedures;
- Willing to provide informed consent.
Who cannot join
- 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;
- Taking medications for blood glucose management;
- Taking medications or natural health products/supplements associated with weight gain or weight loss (e.g. prednisone, certain cold medications);
- Body weight that has not been stable (± 5%) over the past 3 months;
- 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;
- Current (within the past 30 days) bacterial, viral or fungal infection;
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- Uncontrolled hypothyroidism;
- Uncontrolled blood pressure;
- Bleeding disorder;
- Any acute medical condition or surgical intervention within the past 3 months;
- Cigarette/cigar smoking or use of tobacco products within the last 12 months or during participation in the study;
- Consumption of >10 alcoholic beverages per week or >2 alcoholic beverages per day within the last 3 months or while participating in the study;
- Drug and/or alcohol abuse;
- Psychological disorder(s);
- Unable to obtain blood sample at the screening or week 0 visits.
Trial locations and contacts
1 site in 1 country.
Canada1 site
I.H Asper Clinical Research Institute, St. Boniface Hospital
Winnipeg, Manitoba, R2H 2A6
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Pea Protein, Whey Protein, Maltodextrin
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pea ProteinOther
Also called NUTRALYS S85
Soluble pea protein
Whey ProteinOther
Also called Whey Protein Concentrate 80 Instant Kosher
Whey protein concentrate
MaltodextrinOther
Also called GLUCIDEX 19
Non-protein isocaloric comparator
| Study group | Role | What they receive |
|---|---|---|
| Pea Protein | Experimental | 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. Receives: Other: Pea Protein |
| Whey Protein | Active comparator | 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. Receives: Other: Whey Protein |
| Maltodextrin | Placebo comparator | Participants will consume maltodextrin (isocaloric non-protein comparator) as a powder incorporated into foods or beverages at least twice per day for 12 weeks. Receives: Other: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle mass
Muscle mass will be assessed by dual x-ray absorptiometry
Measured: Baseline and 12 weeks
Change in muscle function (hand grip)
A dynamometer will be used to measure hand grip strength
Measured: Baseline and 12 weeks
Change in muscle function (gait test)
A gait test will be performed
Measured: Baseline and 12 weeks
Secondary outcomes (15)
Change in fat mass
Fat mass will be measured by dual x-ray absorptiometry
Measured: Baseline and 12 weeks
Change in body weight and body mass index
Body weight will be measured and used for calculation of body mass index
Measured: Baseline and 12 weeks
Change in waist and waist to height ratio
Waist circumferences will be measured and used for calculation of waist to height ratio
Measured: Baseline and 12 weeks
Change in resting energy expenditure
Resting energy expenditure will be measured by metabolic cart
Measured: Baseline and 12 weeks
Change in C-reactive protein
A fasting venous blood sample will be analyzed for C-reactive protein to assess inflammatory status
Measured: Baseline and 12 weeks
Change in homeostatic model for insulin resistance (HOMA-IR)
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
Measured: Baseline and 12 weeks
Change in glycated hemoglobin
A fasting venous blood sample will be analyzed for glycated hemoglobin
Measured: Baseline and 12 weeks
Change in blood lipid profile
A fasting venous blood sample will be analyzed for total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides as the blood lipid profile
Measured: Baseline and 12 weeks
Change in kidney function (based on profile of circulating markers)
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
Measured: Baseline and 12 weeks
Change in kidney function (based on profile of urinary markers)
A spot urine sample will be analyzed for urine albumin, creatinine and urea to obtain a profile of urinary markers for assessing kidney function
Measured: Baseline and 12 weeks
Change in liver function (based on profile of circulating markers)
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
Measured: Baseline and 12 weeks
Change in systolic and diastolic blood pressure
Systolic and diastolic blood pressure will be measured
Measured: Baseline and 12 weeks
Changes in blood vessel function
Pulse wave velocity measurements will obtained for assessment of arterial stiffness, an indicator of blood vessel function
Measured: Baseline and 12 weeks
24 h activity patterns over time
Participants will wear a Fitbit to monitor 24 hour activity patterns
Measured: Up to 12 weeks
Food intake over time
Participants will complete 3-Day Food Records at 3 week intervals for analysis of nutrient intake
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start17 Oct 2019
- Primary completion2 May 2023
- Study completion2 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Peter Zahradka, University of Manitoba
- Investigators
- Peter Zahradka, PhD, Principal investigator, St. Boniface Hospital Albrechtsen Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123938
- Sponsor's protocol ID
- HS22196
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2019
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Examine the Effect of Pea Protein on Limiting the Loss of Muscle Mass During Weight Loss
- ClinicalTrials.gov ID
- NCT04123938
- Acronym / sponsor ID
- HS22196
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 17 Oct 2019 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 11 Oct 2019 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pea Protein | Experimental | Other: Pea ProteinParticipants 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. |
| Whey Protein | Active comparator | Other: Whey ProteinParticipants 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. |
| Maltodextrin | Placebo comparator | Other: MaltodextrinParticipants will consume maltodextrin (isocaloric non-protein comparator) as a powder incorporated into foods or beverages at least twice per day for 12 weeks. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Male, or non-pregnant, non-lactating female, 30 to 50 years of age;
- BMI >30 and body weight does not exceed the capacity of the DEXA (350 lbs);
- Fat mass >23% for males and >32% for females (determined at the screening visit via bioelectrical impedance);
- Willing to maintain a stable level of activity while participating in the study;
- Plasma creatinine ≤265 µmol/L;
Key exclusion criteria (15 listed)
- 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;
- Taking medications for blood glucose management;
- Taking medications or natural health products/supplements associated with weight gain or weight loss (e.g. prednisone, certain cold medications);
- Body weight that has not been stable (± 5%) over the past 3 months;
- 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;
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 |
|---|---|---|
| Pea ProteinAlso: NUTRALYS S85Soluble pea protein | Other | Pea Protein |
| Whey ProteinAlso: Whey Protein Concentrate 80 Instant KosherWhey protein concentrate | Other | Whey Protein |
| MaltodextrinAlso: GLUCIDEX 19Non-protein isocaloric comparator | Other | Maltodextrin |
Primary outcome
Change in muscle mass
Time frame: Baseline and 12 weeks
Muscle mass will be assessed by dual x-ray absorptiometry
Change in muscle function (hand grip)
Time frame: Baseline and 12 weeks
A dynamometer will be used to measure hand grip strength
Change in muscle function (gait test)
Time frame: Baseline and 12 weeks
A gait test will be performed
15 secondary outcomes
Change in fat mass
Time frame: Baseline and 12 weeks
Change in body weight and body mass index
Time frame: Baseline and 12 weeks
Change in waist and waist to height ratio
Time frame: Baseline and 12 weeks
Change in resting energy expenditure
Time frame: Baseline and 12 weeks
Change in C-reactive protein
Time frame: Baseline and 12 weeks
Change in homeostatic model for insulin resistance (HOMA-IR)
Time frame: Baseline and 12 weeks
Change in glycated hemoglobin
Time frame: Baseline and 12 weeks
Change in blood lipid profile
Time frame: Baseline and 12 weeks
Change in kidney function (based on profile of circulating markers)
Time frame: Baseline and 12 weeks
Change in kidney function (based on profile of urinary markers)
Time frame: Baseline and 12 weeks
Change in liver function (based on profile of circulating markers)
Time frame: Baseline and 12 weeks
Change in systolic and diastolic blood pressure
Time frame: Baseline and 12 weeks
Changes in blood vessel function
Time frame: Baseline and 12 weeks
24 h activity patterns over time
Time frame: Up to 12 weeks
Food intake over time
Time frame: Up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- 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.
Peter Zahradka, PhD principal investigator
St. Boniface Hospital Albrechtsen Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pea Protein, Whey Protein and Maltodextrin in people with Obesity, run by University of Manitoba 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 16 inclusion and 15 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: finished, as of the sponsor's last update on 5 Sep 2025. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in muscle mass (time frame: Baseline and 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2025.