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 range30 Years – 50 Years

SexALL

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;
✕. 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;
✕. Uncontrolled hypothyroidism;
✕. Uncontrolled blood pressure;

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 range30 Years – 50 Years

SexALL

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;
✕. 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;
✕. Uncontrolled hypothyroidism;
✕. Uncontrolled blood pressure;