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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Soluble pea protein
Whey protein concentrate
Non-protein isocaloric comparator
I.H Asper Clinical Research Institute, St. Boniface Hospital
Winnipeg, Manitoba, Canada
Change in muscle mass
Muscle mass will be assessed by dual x-ray absorptiometry
Time frame: Baseline and 12 weeks
Change in muscle function (hand grip)
A dynamometer will be used to measure hand grip strength
Time frame: Baseline and 12 weeks
Change in muscle function (gait test)
A gait test will be performed
Time frame: Baseline and 12 weeks
Change in fat mass
Fat mass will be measured by dual x-ray absorptiometry
Time frame: 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
Time frame: 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
Time frame: Baseline and 12 weeks
Change in resting energy expenditure
Resting energy expenditure will be measured by metabolic cart
Time frame: 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
Time frame: Baseline and 12 weeks
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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
Time frame: Baseline and 12 weeks
Change in glycated hemoglobin
A fasting venous blood sample will be analyzed for glycated hemoglobin
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and 12 weeks
Change in systolic and diastolic blood pressure
Systolic and diastolic blood pressure will be measured
Time frame: 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
Time frame: Baseline and 12 weeks
24 h activity patterns over time
Participants will wear a Fitbit to monitor 24 hour activity patterns
Time frame: Up to 12 weeks
Food intake over time
Participants will complete 3-Day Food Records at 3 week intervals for analysis of nutrient intake
Time frame: Up to 12 weeks