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Effect of Peas in Muffins on Blood Glucose and Appetite Control (PEA3)

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ClinicalTrials.gov Identifier: NCT03306706
Recruitment Status : Recruiting
First Posted : October 11, 2017
Last Update Posted : April 17, 2018
Sponsor:
Collaborators:
Agriculture and Agri-Food Canada
University of Manitoba
Information provided by (Responsible Party):
Dr. Heather Blewett, St. Boniface General Hospital Research Centre

Brief Summary:
This study is part of a group of studies whose overall goal is to accurately define the physiochemical and structural effects of pea varieties and relate these to blood glucose attenuation and appetite related sensations in healthy human volunteers.

Condition or disease Intervention/treatment Phase
Post-prandial Glycaemic Response Satiety Dietary Supplement: Whole pea muffins Dietary Supplement: Split pea muffins Dietary Supplement: Wheat muffins Not Applicable

Detailed Description:
A randomized, controlled, cross-over study designed to examine the postprandial glycaemic response and appetite related sensations to peas in muffins will be conducted at the I.H. Asper Clinical Research Institute in Winnipeg, Manitoba. Eligible participants who have provided consent will be asked to attend 4 clinic visits in a fasted state. Participants will be given muffins containing peas at 2 visits and muffins without peas at 2 visits. At each visit participants will provide 7 venous blood samples via indwelling catheter, 7 capillary blood samples via finger poke, 2 urine samples, 5 questionnaires about their appetite and a questionnaire about the acceptability of the products. At the end of each visit, participants will eat pizza ad libitum, and the amount of pizza consumed will be measured to determine if the peas influenced the amount of calories consumed at lunch. Participants will record their food/beverage intake for the rest of the day. Each visit will last approximately 3h and be separated by 3-14 days.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: randomized, controlled, cross-over
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized, Controlled, Cross-over Trial Examining the Effect of Peas in Muffins on Post-prandial Glycaemic Response and Satiety in Healthy Adults.
Actual Study Start Date : November 7, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Experimental: whole yellow pea
2 muffins containing 25g available carbohydrate from whole yellow peas. Intervention: Whole pea muffins
Dietary Supplement: Whole pea muffins
2 muffins containing whole peas

Experimental: split yellow pea
2 muffins containing 25g available carbohydrate from split yellow peas. Intervention: Split pea muffins
Dietary Supplement: Split pea muffins
2 muffins containing split peas

Placebo Comparator: wheat-PPGR
2 muffins containing 25g available carbohydrate from wheat flour. Intervention: Wheat muffins
Dietary Supplement: Wheat muffins
2 muffins containing wheat

Placebo Comparator: wheat-satiety

2 muffins containing wheat flour to match the calories in the whole and split pea muffins.

Intervention: Wheat muffins

Dietary Supplement: Wheat muffins
2 muffins containing wheat




Primary Outcome Measures :
  1. Post-prandial glucose response [ Time Frame: 120 min ]
    iAUC glucose

  2. Post-prandial insulin [ Time Frame: 120 min ]
    iAUC insulin


Secondary Outcome Measures :
  1. Appetite ratings [ Time Frame: 120 min ]
    AUC for hunger, fullness, desire to eat and prospective consumption using visual analog scales


Other Outcome Measures:
  1. calorie intake [ Time Frame: 16 hours ]
    Number of calories consumed post-intervention until bedtime

  2. Metabolomics [ Time Frame: 120 min ]
    Metabolite profile in plasma and urine

  3. Acceptability of test products [ Time Frame: 15 min ]
    Rating of color, aroma, flavor, texture and frequency of eating

  4. Gastrointestinal side effects [ Time Frame: 24h ]
    Incidence and duration of GI side effects



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Generally healthy male or female, between the age of 18-40 years;
  2. Body mass index (BMI) 18.5-30.0 kg/m2;
  3. Habitually consume breakfast, lunch and dinner in the morning, mid-day and evening, respectively.
  4. Willing to provide informed consent;
  5. Willing/able to comply with the requirements of the study.

Exclusion Criteria:

  1. Pregnant or lactating;
  2. Medical history of diabetes mellitus, fasting blood glucose ≥6.1 mmol/L, HbA1c ≥6.0%, or use of insulin or oral medication to control blood sugar;
  3. Medical history of cardiovascular disease;
  4. Systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg;
  5. Fasting plasma total cholesterol >7.8 mmol/L;
  6. Fasting plasma HDL <0.9 mmol/L;
  7. Fasting plasma LDL >5.0 mmol/L;
  8. Fasting plasma triglycerides >2.3 mmol/L;
  9. Major surgery within the last 3 months;
  10. Medical history of inflammatory disease (ie. Systemic lupus erythematosis, rheumatoid arthritis, psoriasis) or use of any corticosteroid medications within 3 months;
  11. Medical history of liver disease or liver dysfunction (defined as plasma AST or ALT ≥1.5 times the upper limit of normal (ULN));
  12. Medical history of kidney disease or kidney dysfunction (defined as blood urea nitrogen and creatinine ≥ 1.8 times the ULN));
  13. Presence of a gastrointestinal disorder, daily use of any stomach acid-lowering medications or laxatives (including fibre supplements) within the past month or antibiotic use within the past 6 weeks;
  14. Active treatment for any type of cancer within 1 year prior to study start;
  15. Shift worker (a system of employment where an individual's normal hours of work are in part, outside the period of normal working day; 6am and 8pm);
  16. Smoking, use of tobacco or a nicotine replacement product (within the last 3 months);
  17. Allergies to peas;
  18. Aversion or unwillingness to eat study foods;
  19. Consuming >4 servings of pulses per week;
  20. Use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect glycaemia or appetite;
  21. Participation in another clinical trial, current or in the past 4 weeks;
  22. Unstable body weight (defined as >5% change in 3 months) or actively participating in a weight loss program.
  23. Physical Activity Level >1.8.
  24. Restraint score >13 (factor 1) on the Three Factor Eating Questionnaire.
  25. Other medical, psychiatric, or behavioral factors that in the judgment of the principal Investigator may interfere with study participation or the ability to follow the intervention protocol;

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): NCT03306706


Contacts
Contact: Heather Blewett, PhD 2042372954 hblewett@sbrc.ca

Locations
Canada, Manitoba
I.H. Asper Clinical Research Institute Recruiting
Winnipeg, Manitoba, Canada, R2H2A6
Contact: Heather Blewett, Ph.D    204-237-2954    hblewett@sbrc.ca   
Contact: Jay Petkau       jpetkau@sbrc.ca   
Sub-Investigator: Dan Ramdath, Ph.D         
Sub-Investigator: Sora Ludwig, MD         
Sub-Investigator: Michel Aliani, Ph.D         
Sponsors and Collaborators
St. Boniface General Hospital Research Centre
Agriculture and Agri-Food Canada
University of Manitoba
Investigators
Principal Investigator: Heather Blewett, PhD Agriculture and Agri-Food Canada

Publications:
Public Health Agency of Canada and the Canadian Institute for Health Information. Obesity in Canada: A joint report from the Public Health Agency of Canada and the Canadian institute for health information. Government of Canada; 2011.
Public Health Authority of Canada. Diabetes in Canada: Facts and figures from a public health perspective. 2011
European Food Safety Authority. Guidance on the scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrations. EFSA Journal. 2012;10(3):2604.
Health Canada. Draft guidance document: Satiety health claims on food [Internet].; 2012. Available from: http://www.hc-sc.gc.ca/fn-an/consult/satiety-satiete/document-consultation-eng.php

Responsible Party: Dr. Heather Blewett, Principal Investigator, St. Boniface General Hospital Research Centre
ClinicalTrials.gov Identifier: NCT03306706     History of Changes
Other Study ID Numbers: RRC/2017/1702
HS21108 (B2017:106) ( Other Identifier: Biomedical Research Ethics Board, University of Manitoba )
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Once data has been collected until manuscript is accepted for publication.
Access Criteria: Dan Ramdath, Sora Ludwig and Michel Aliani will have access to data necessary for manuscript preparation.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Heather Blewett, St. Boniface General Hospital Research Centre:
blood sugar
insulin
appetite
peas