CompletedNot Applicable

Pea Protein and Muscle Mass During Weight Loss

Canada60 participantsStarted 2019-10-17

Plain-language 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.

Who can participate

Age range

30 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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;
. Aspartate aminotransferase \<160 U/L, and alanine aminotransferase \<150 U/L;
. Glycated hemoglobin \<6.5%;

Exclusion criteria

. 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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in muscle mass

Timeframe: Baseline and 12 weeks

Change in muscle function (hand grip)

Timeframe: Baseline and 12 weeks

Change in muscle function (gait test)

Timeframe: Baseline and 12 weeks

Trial details

NCT IDNCT04123938

SponsorUniversity of Manitoba

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-02

View on ClinicalTrials.gov More Obesity trials

Who can participate

Age range

30 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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;
. Aspartate aminotransferase \<160 U/L, and alanine aminotransferase \<150 U/L;
. Glycated hemoglobin \<6.5%;

Exclusion criteria

. 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;