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OpenTrials
Completed

NCT Number: NCT03506932

Effect of Pea Flour in Bread on Blood Glucose

This study's overall goal is to investigate methods to improve the acceptability of pulse containing foods that provide a health benefit to consumers. The health benefits we are testing are post-prandial blood glucose attenuation and appetite related sensations in healthy human volunteers.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

I. H. Asper Clinical Research Institute

Winnipeg, Manitoba, R2H 2A6, Canada

About this study

A randomized, controlled, cross-over study designed to examine the post-prandial glycaemic response, metabolism of bioactives and appetite related sensations to 20% incorporation of yellow pea flour (untreated, heat treated with 0% moisture and heat treated with 10% moisture) into bread 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 bread containing 20% yellow pea flour at 3 visits and bread with 100% wheat flour at 1 visit. 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. Each visit will last approximately 3h and be separated by 3-14 days.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnant or lactating;
  • 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;
  • Medical history of cardiovascular disease;
  • Systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg;
  • Fasting plasma total cholesterol >7.8 mmol/L;
  • Fasting plasma HDL <0.9 mmol/L;
  • Fasting plasma LDL >5.0 mmol/L;
  • Fasting plasma triglycerides >2.3 mmol/L;
  • Major surgery within the last 3 months;
  • Medical history of inflammatory disease (ie. Systemic lupus erythematosis, rheumatoid arthritis, psoriasis) or use of any corticosteroid medications within 3 months;
  • Medical history of liver disease or liver dysfunction (defined as plasma aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3 times the upper limit of normal (ULN));
  • Medical history of kidney disease or kidney dysfunction (defined as blood urea nitrogen and creatinine ≥3 times the ULN));
  • 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;
  • Active treatment for any type of cancer within 1 year prior to study start;
  • 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);
  • Smoking, use of tobacco or a nicotine replacement product, and cannabis in any form (within the last 3 months);
  • Allergies to peas or wheat;
  • Aversion or unwillingness to eat study foods;
  • Consuming >4 servings of pulses per week;
  • Use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect glycaemia or appetite;
  • Participation in another clinical trial, current or in the past 4 weeks;
  • Unstable body weight (defined as >5% change in 3 months) or actively participating in a weight loss program.
  • 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;

Treatment and study plan

Untreated

Dietary Supplement

Bread made with 20% yellow pea flour that was untreated.

Heat treated with 0% moisture

Dietary Supplement

Bread made with 20% yellow pea flour that was heat treated with 0% moisture.

Heat treated with 10% moisture

Dietary Supplement

Bread made with 20% yellow pea flour that was heat treated with 10% moisture.

Wheat

Dietary Supplement

Bread made with 100% wheat

Primary outcomes

  1. Post-prandial glucose

    Time frame: 120 minutes

    incremental area under the curve (iAUC) for glucose

  2. Post-prandial insulin

    Time frame: 120 minutes

    iAUC insulin

Secondary outcomes

  1. Urinary metabolite profile

    Time frame: 120 minutes

    Concentration of metabolites in urine

  2. Plasma metabolite profile

    Time frame: 120 minutes

    Concentration of metabolites in plasma

Other outcomes

  1. Hunger

    Time frame: 120 minutes

    Area under the curve (AUC) using visual analog scales

  2. Fullness

    Time frame: 120 minutes

    AUC using visual analog scales

  3. Desire to eat

    Time frame: 120 minutes

    AUC using visual analog scales

  4. Prospective consumption

    Time frame: 120 minutes

    AUC using visual analog scales

  5. Acceptability of test products

    Time frame: 15 minutes

    Ratings of color, aroma, flavor, texture and frequency of eating

  6. Gastrointestinal effects

    Time frame: 24 hours

    Incidence of gastrointestinal side effects

Sponsors and collaborators

Lead sponsor

St. Boniface Hospital

Other

Collaborators

  • Agriculture and Agri-Food Canada
  • Saskatchewan Pulse Growers
  • University of Manitoba

Registry information

Official study title

A Randomized, Controlled, Cross-over Trial Examining the Effect of Yellow Pea Flour in Bread on Post-prandial Glycaemic Response in Healthy Adults

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 24, 2018
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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