Pea Protein and Muscle Mass During Weight Loss

NCT04123938 | Completed

• 1 other identifier: HS22196
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (3)

• Change in muscle mass

  Muscle mass will be assessed by dual x-ray absorptiometry

  Baseline and 12 weeks

• Change in muscle function (hand grip)

  A dynamometer will be used to measure hand grip strength

  Baseline and 12 weeks

• Change in muscle function (gait test)

  A gait test will be performed

  Baseline and 12 weeks

Secondary Outcomes (15)

• Change in fat mass

  Baseline and 12 weeks

• Change in body weight and body mass index

  Baseline and 12 weeks

• Change in waist and waist to height ratio

  Baseline and 12 weeks

• Change in resting energy expenditure

  Baseline and 12 weeks

• Change in C-reactive protein

  Baseline and 12 weeks

Study Arms (3)

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.

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.

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.

Other: Maltodextrin

Interventions

Pea Protein OTHER

Soluble pea protein

Also known as: NUTRALYS S85

Pea Protein

Whey Protein OTHER

Whey protein concentrate

Also known as: Whey Protein Concentrate 80 Instant Kosher

Whey Protein

Maltodextrin OTHER

Non-protein isocaloric comparator

Also known as: GLUCIDEX 19

Maltodextrin

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

I.H Asper Clinical Research Institute, St. Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

MeSH Terms

Conditions

Obesity

Interventions

Pea Proteins; Whey Proteins; maltodextrin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Milk Proteins; Animal Proteins, Dietary; Whey; Milk; Dairy Products

Study Officials

• Peter Zahradka, PhD

  St. Boniface Hospital Albrechtsen Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: October 11, 2019
• Study Start: October 17, 2019
• Primary Completion: May 2, 2023
• Study Completion: May 2, 2023
• Last Updated: September 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)