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Trial record 67 of 593 for:    maltodextrin

Pea Protein and Muscle Mass During Weight Loss

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ClinicalTrials.gov Identifier: NCT04123938
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Peter Zahradka, University of Manitoba

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.

Condition or disease Intervention/treatment Phase
Obesity Other: Pea Protein Other: Whey Protein Other: Maltodextrin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study to Examine the Effect of Pea Protein on Limiting the Loss of Muscle Mass During Weight Loss
Actual Study Start Date : October 17, 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


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.
Other: Pea Protein
Soluble pea protein
Other Name: NUTRALYS S85

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.
Other: Whey Protein
Whey protein concentrate
Other Name: Whey Protein Concentrate 80 Instant Kosher

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.
Other: Maltodextrin
Non-protein isocaloric comparator
Other Name: GLUCIDEX 19




Primary Outcome Measures :
  1. Change in muscle mass [ Time Frame: Baseline and 12 weeks ]
    Muscle mass will be assessed by dual x-ray absorptiometry

  2. Change in muscle function (hand grip) [ Time Frame: Baseline and 12 weeks ]
    A dynamometer will be used to measure hand grip strength

  3. Change in muscle function (gait test) [ Time Frame: Baseline and 12 weeks ]
    A gait test will be performed


Secondary Outcome Measures :
  1. Change in fat mass [ Time Frame: Baseline and 12 weeks ]
    Fat mass will be measured by dual x-ray absorptiometry

  2. 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

  3. 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

  4. Change in resting energy expenditure [ Time Frame: Baseline and 12 weeks ]
    Resting energy expenditure will be measured by metabolic cart

  5. 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

  6. 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

  7. Change in glycated hemoglobin [ Time Frame: Baseline and 12 weeks ]
    A fasting venous blood sample will be analyzed for glycated hemoglobin

  8. 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

  9. 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

  10. 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

  11. 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

  12. Change in systolic and diastolic blood pressure [ Time Frame: Baseline and 12 weeks ]
    Systolic and diastolic blood pressure will be measured

  13. 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

  14. 24 h activity patterns over time [ Time Frame: Up to 12 weeks ]
    Participants will wear a Fitbit to monitor 24 hour activity patterns

  15. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male, or non-pregnant, non-lactating female, 30 to 50 years of age;
  2. BMI >30 and body weight does not exceed the capacity of the DEXA (350 lbs);
  3. Fat mass >23% for males and >32% for females (determined at the screening visit via bioelectrical impedance);
  4. Willing to maintain a stable level of activity while participating in the study;
  5. Plasma creatinine ≤265 µmol/L;
  6. Plasma LDL-cholesterol <5 mmol/L;
  7. Aspartate aminotransferase <160 U/L, and alanine aminotransferase <150 U/L;
  8. Glycated hemoglobin <6.5%;
  9. Blood pressure <160 mmHg systolic and <100 mmHg diastolic;
  10. Stable regime if taking vitamin and mineral/dietary/herbal supplements for the past 1 month and while participating in the study;
  11. Not taking protein supplements for the past month and willing to continue doing so for the duration of the study;
  12. 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;
  13. Female participants of child-bearing potential must agree to use a highly effective method of contraception throughout the study;
  14. 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;
  15. Willing to comply with the protocol requirements and procedures;
  16. Willing to provide informed consent.

Exclusion Criteria:

  1. 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;
  2. Taking medications for blood glucose management;
  3. Taking medications or natural health products/supplements associated with weight gain or weight loss (e.g. prednisone, certain cold medications);
  4. Body weight that has not been stable (± 5%) over the past 3 months;
  5. 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;
  6. Current (within the past 30 days) bacterial, viral or fungal infection;
  7. Uncontrolled hypothyroidism;
  8. Uncontrolled blood pressure;
  9. Bleeding disorder;
  10. Any acute medical condition or surgical intervention within the past 3 months;
  11. Cigarette/cigar smoking or use of tobacco products within the last 12 months or during participation in the study;
  12. Consumption of >10 alcoholic beverages per week or >2 alcoholic beverages per day within the last 3 months or while participating in the study;
  13. Drug and/or alcohol abuse;
  14. Psychological disorder(s);
  15. Unable to obtain blood sample at the screening or week 0 visits.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04123938


Contacts
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Contact: Peter Zahradka, PhD 204-235-3507 pzahradka@sbrc.ca
Contact: Carla G Taylor, PhD 204-258-1361 ctaylor@sbrc.ca

Locations
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Canada, Manitoba
I.H Asper Clinical Research Institute, St. Boniface Hospital Recruiting
Winnipeg, Manitoba, Canada, R2H 2A6
Contact: Peter C Zahradka, PhD    (204) 235-3507    pzahradka@sbrc.ca   
Contact: Carla G Taylor, PhD    (204) 258-1361    ctaylor@sbrc.ca   
Principal Investigator: Peter C Zahradka, PhD         
Sponsors and Collaborators
University of Manitoba
Investigators
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Principal Investigator: Peter Zahradka, PhD St. Boniface Hospital Albrechtsen Research Centre

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Responsible Party: Dr. Peter Zahradka, Principal Investigator, University of Manitoba
ClinicalTrials.gov Identifier: NCT04123938     History of Changes
Other Study ID Numbers: HS22196
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms