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

January 31, 2024 updated by: Dr. Heather Blewett, St. Boniface Hospital

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

24

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 Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H2A6
        • I.H. Asper Clinical Research Institute

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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;

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Whole yellow pea
Chili containing 25g available carbohydrate from whole yellow peas. Intervention: Whole yellow pea chili
Dietary supplement: Whole yellow pea chili
Chili containing whole yellow peas
Experimental: Split yellow pea
Chili containing 25g available carbohydrate from split yellow peas. Intervention: Split yellow pea chili
Dietary supplement: Split yellow pea chili
Chili containing split yellow peas
Placebo Comparator: Rice-PPGR
Chili containing 25g available carbohydrate from long grain white rice. Intervention: Rice chili
Dietary supplement: Rice chili
Chili containing long grain white rice
Placebo Comparator: Rice-Satiety
Rice chili with the same calories as the pea chili. Intervention: Rice chili
Dietary supplement: Rice chili
Chili containing long grain white rice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-prandial insulin
Time Frame: 120 min
iAUC insulin
120 min
Post-prandial glucose
Time Frame: 120 min
iAUC for glucose
120 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appetite scores
Time Frame: 120 min
AUC for hunger, fullness, desire to eat and prospective consumption using visual analog scales
120 min

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calorie consumption
Time Frame: 16 h
number of calories consumed post-meal until bedtime
16 h
Metabolomics
Time Frame: 120 min
metabolite profile in plasma and urine
120 min
Acceptability of test products
Time Frame: 15 min
Ratings of color, aroma, flavor, texture and frequency of eating
15 min
Gastrointestinal effects
Time Frame: 24 h
Incidence and duration of gastrointestinal side effects
24 h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Boniface Hospital

Collaborators

University of Manitoba
Agriculture and Agri-Food Canada

Investigators

  • Principal Investigator: Heather Blewett, PhD, Agriculture and Agri-Food Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 8, 2017

Primary Completion (Actual)

November 12, 2019

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

October 2, 2017

First Submitted That Met QC Criteria

October 5, 2017

First Posted (Actual)

October 11, 2017

Study Record Updates

Last Update Posted (Estimated)

February 2, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RRC/2017/1703
  • HS21116 (B2017:108) (Other Identifier: Biomedical Research Ethics Board, University of Manitoba)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication.

IPD Sharing Time Frame

From the time the data is collected until manuscript is accepted for publication.

IPD Sharing Access Criteria

Dan Ramdath, Sora Ludwig and Michel Aliani will have access to data necessary for manuscript preparation.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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.

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