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Effect of Peas in Chili on Blood Glucose and Appetite Control (PEA5)

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ClinicalTrials.gov Identifier: NCT03306927
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

October 2, 2017
October 11, 2017
April 17, 2018
November 8, 2017
March 2019   (Final data collection date for primary outcome measure)
  • Post-prandial glucose [ Time Frame: 120 min ]
    iAUC for glucose
  • Post-prandial insulin [ Time Frame: 120 min ]
    iAUC insulin
Same as current
Complete list of historical versions of study NCT03306927 on ClinicalTrials.gov Archive Site
Appetite scores [ Time Frame: 120 min ]
AUC for hunger, fullness, desire to eat and prospective consumption using visual analog scales
Same as current
  • Calorie consumption [ Time Frame: 16 h ]
    number of calories consumed post-meal until bedtime
  • Metabolomics [ Time Frame: 120 min ]
    metabolite profile in plasma and urine
  • Acceptability of test products [ Time Frame: 15 min ]
    Ratings of color, aroma, flavor, texture and frequency of eating
  • Gastrointestinal effects [ Time Frame: 24 h ]
    Incidence and duration of gastrointestinal side effects
Same as current
 
Effect of Peas in Chili on Blood Glucose and Appetite Control
A Randomized, Controlled, Cross-over Trial Examining the Effect of Peas in Chili on Post-prandial Glycaemic Response and Satiety in Healthy Adults.
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.
A randomized, controlled, cross-over study designed to examine the PPGR and appetite related sensations to peas in chili 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 vegetarian chili containing peas at 2 visits and rice 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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Randomized, controlled, cross-over study
Masking: None (Open Label)
Primary Purpose: Prevention
  • Post-prandial Glycaemic Response
  • Satiety
  • Dietary Supplement: Whole yellow pea chili
    Chili containing whole yellow peas
  • Dietary Supplement: Split yellow pea chili
    Chili containing split yellow peas
  • Dietary Supplement: Rice chili
    Chili containing long grain white rice
  • Experimental: Whole yellow pea
    Chili containing 25g available carbohydrate from whole yellow peas. Intervention: Whole yellow pea chili
    Intervention: Dietary Supplement: Whole yellow pea chili
  • Experimental: Split yellow pea
    Chili containing 25g available carbohydrate from split yellow peas. Intervention: Split yellow pea chili
    Intervention: Dietary Supplement: Split yellow pea chili
  • Placebo Comparator: Rice-PPGR
    Chili containing 25g available carbohydrate from long grain white rice. Intervention: Rice chili
    Intervention: Dietary Supplement: Rice chili
  • Placebo Comparator: Rice-Satiety
    Rice chili with the same calories as the pea chili. Intervention: Rice chili
    Intervention: Dietary Supplement: Rice chili

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
Same as current
August 2019
March 2019   (Final data collection date for primary outcome measure)

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;
Sexes Eligible for Study: All
18 Years to 40 Years   (Adult)
Yes
Contact: Heather Blewett, PhD 204-237-2954 hblewett@sbrc.ca
Canada
 
 
NCT03306927
RRC/2017/1703
HS21116 (B2017:108) ( Other Identifier: Biomedical Research Ethics Board, University of Manitoba )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: From the time the data is 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.
Dr. Heather Blewett, St. Boniface General Hospital Research Centre
St. Boniface General Hospital Research Centre
  • Agriculture and Agri-Food Canada
  • University of Manitoba
Principal Investigator: Heather Blewett, PhD Agriculture and Agri-Food Canada
St. Boniface General Hospital Research Centre
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP