- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04123938
Pea Protein and Muscle Mass During Weight Loss
August 1, 2023 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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
60
Phase
- 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
- Name: Peter Zahradka, PhD
- Phone Number: 204-235-3507
- Email: pzahradka@sbrc.ca
Study Contact Backup
- Name: Carla G Taylor, PhD
- Phone Number: 204-258-1361
- Email: ctaylor@sbrc.ca
Study Locations
-
-
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
Ages Eligible for Study
30 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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%;
- 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.
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;
- 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.
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 |
Intervention / Treatment |
---|---|
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.
|
Soluble pea protein
Other Names:
|
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.
|
Whey protein concentrate
Other Names:
|
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.
|
Non-protein isocaloric comparator
Other Names:
|
What is the study measuring?
Primary Outcome Measures
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
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
Investigators
- 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)
October 17, 2019
Primary Completion (Actual)
May 2, 2023
Study Completion (Actual)
May 2, 2023
Study Registration Dates
First Submitted
September 26, 2019
First Submitted That Met QC Criteria
October 9, 2019
First Posted (Actual)
October 11, 2019
Study Record Updates
Last Update Posted (Actual)
August 3, 2023
Last Update Submitted That Met QC Criteria
August 1, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuNot yet recruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on Pea Protein
-
University of ManitobaSaskatchewan Pulse Growers; Alberta Pulse GrowersCompleted
-
University of ManitobaSaskatchewan Pulse Growers; Alberta Pulse GrowersCompletedDiabetes Prevention | Obesity Prevention
-
University of ManitobaSaskatchewan Pulse Growers; Alberta Pulse GrowersCompleted
-
University of ManitobaSaskatchewan Pulse Growers; Alberta Pulse GrowersCompleted
-
University of BonnGerman Federal Ministry of Education and Research; University of Bonn, Department...RecruitingPlasma Amino Acid Appearance and Disappearance | Postprandial Metabolic EventsGermany
-
Purdue UniversityCompletedAppetitive BehaviorUnited States
-
Örebro University, SwedenRecruitingIleostomy - StomaSweden
-
University of TorontoAgriculture and Agri-Food Canada; Pulse CanadaCompletedObesity | Metabolic Syndrome | Type II Diabetes MellitusCanada
-
Wageningen UniversityNIZO Food Research; Ingredia S.A.Not yet recruiting