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Active, Not Recruiting

NCT Number: NCT03306862

Effect of Peas in Soup on Blood Glucose Control

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 in healthy human volunteers.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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, R2H2A6, Canada

About this study

A randomized, controlled, cross-over study designed to examine the post-prandial glycaemic response to peas in soup 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 3 clinic visits in a fasted state. Participants will be given soup containing peas at 2 visits and soup without peas at 1 visit. At each visit participants will provide 7 capillary blood samples via finger poke, 5 questionnaires about their appetite and a questionnaire about the acceptability of the products. Each visit will last approximately 2.5h 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 AST or ALT ≥1.5 times the upper limit of normal (ULN));
  • Medical history of kidney disease or kidney dysfunction (defined as blood urea nitrogen and creatinine ≥ 1.8 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 (within the last 3 months);
  • Allergies to peas;
  • 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

Whole yellow pea soup

Dietary Supplement

Soup containing whole yellow peas

Split yellow pea soup

Dietary Supplement

Soup containing split yellow peas

Potato soup

Dietary Supplement

Soup containing potatoes

Primary outcomes

  1. Post-prandial glucose

    Time frame: 120 min

    iAUC for glucose

  2. Post-prandial insulin

    Time frame: 120 min

    iAUC for insulin

Secondary outcomes

  1. Hunger

    Time frame: 120 min

    AUC using visual analog scales

  2. Fullness

    Time frame: 120 min

    AUC using visual analog scales

  3. Desire to eat

    Time frame: 120 min

    AUC using visual analog scales

  4. Prospective consumption

    Time frame: 120 min

    AUC using visual analog scales

Other outcomes

  1. Acceptability of soup color

    Time frame: 15 min

    Ratings on a scale of 1-9

  2. Acceptability of soup aroma

    Time frame: 15 min

    Ratings on a scale of 1-9

  3. Acceptability of soup flavor

    Time frame: 15 min

    Ratings on a scale of 1-9

  4. Acceptability of soup texture

    Time frame: 15 min

    Ratings on a scale of 1-9

  5. Frequency of eating soup

    Time frame: 15 min

    Ratings on a scale of 1-9

  6. Gastrointestinal side effects

    Time frame: 24 h

    Incidence of gastrointestinal effects

Sponsors and collaborators

Lead sponsor

St. Boniface Hospital

Other

Collaborators

  • Agriculture and Agri-Food Canada
  • University of Manitoba

Registry information

Official study title

A Randomized, Controlled, Cross-over Trial Examining the Effect of Peas in Soup on Post-prandial Glycaemic Response in Healthy Adults.

Acronym: PEA4

Important dates

Study start
2017
Primary completion
2018
Study completion
2025
First posted
Oct 11, 2017
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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