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Impact of Pea, Lentil and Oat Flour Particle Size on Glycemic Response in Healthy Adults (PLO)

Primary Purpose

Malnutrition; Diabetes, Malnutrition; Protein, Obesity

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Crackers made with whole, coarse, or fine pea and/or wheat flour

Crackers made with whole, coarse, or fine lentil and/or wheat flour

Porridge made with oat flour or oats

About this trial

This is an interventional prevention trial for Malnutrition; Diabetes focused on measuring Nutrition, Glycemic response, Protein quality, Food processing

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

18-45 years of age
BMI 18.5-29.9 kg/m2
Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
Willing to maintain current dietary supplement use throughout the trial.
Willing to abstain from alcohol consumption for 24h prior to all test visits.
Willing to avoid vigorous physical activity for 24h prior to all test visits.
Understanding the study procedure and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.

Exclusion Criteria:

Smoking
Thyroid problems
Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, a malabsorptive syndrome, pancreatitis, gallbladder or biliary disease.
Presence of a gastrointestinal disorder or surgeries within the past year.
Known to be pregnant or lactating.
Unwillingness or inability to comply with the experimental procedures and to follow our safety guidelines.
Allergies to peanuts and nuts.
Known intolerances, sensitivity or allergy to any ingredients in the study products: pea flour, lentil flour, oat flour and whole wheat flour.
Regular breakfast skipping (consumes breakfast less than 5 days a week)
Extreme dietary habits (i.e Atkins diet, very high protein diets, etc.) or restrained eaters, identified by a score of ≥ 11 on the Eating Habits Questionnaire
Uncontrolled hypertension (systolic blood pressure > 140 mm Hg or diastolic blood pressure > 90 mm Hg) as defined by the average blood pressure measured at screening.
Weight gain or loss of at least 10lbs in previous three months.
Excessive alcohol intake (more than 2 drinks per day or more than 9 drinks per week).
Consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect blood glucose or that could affect the outcome of the study as per investigator's judgment.

Sites / Locations

Department of Nutritional SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Pea

Lentil

Oats

Arm Description

Treatment 1: crackers made with 25% whole pea flour + 75% all-purpose wheat flour; Treatment 2: crackers made with 25% coarse pea flour + 75% all-purpose wheat flour; Treatment 3: crackers made with 25% fine pea flour + 75% all-purpose wheat flour; Treatment 4: crackers made with 100% all-purpose wheat flour (control)

Treatment 1: crackers made with 25% whole lentil flour + 75% all-purpose wheat flour; Treatment 2: crackers made with 25% coarse lentil flour + 75% all-purpose wheat flour; Treatment 3: crackers made with 25% fine lentil flour + 75% all-purpose wheat flour; Treatment 4: crackers made with 100% all-purpose wheat flour (control)

Treatment 1: porridge made with whole oat flour; Treatment 2: porridge made with coarse oat flour; Treatment 3: porridge made with fine oat flour; Treatment 4: porridge made with commercial oat flour (control)

Outcomes

Primary Outcome Measures

Change in postprandial glycemic response

Blood collection via finger prick to analyze blood glucose (glucometer reading) and serum insulin concentration (μIU/mL).

Secondary Outcome Measures

Subjective appetite

Motivation to Eat Adaptive Visual Analogue Scales measured based on a score between 0 to 100. A higher score indicates higher outcome.

Food intake

Measured via amount of pizza (g) consumed at an ad libitum pizza meal.

Protein quality

Intravenous blood collection to analyze amino acid concentrations (μmol/L) to determine amino acid release.

Physical comfort

Physical Comfort Visual Analogue Scales measured based on a score between 0 to 100. A higher score indicates higher outcome.

Energy & fatigue

Energy and Fatigue Visual Analogue Scales measured based on a score between 0 to 100. A higher score indicates higher outcome.

Treatment palatability

Treatment Palatability Visual Analogue Scales measured based on a score between 0 to 100. A higher score indicates higher outcome.

Full Information

NCT ID

NCT05291351

First Posted

February 28, 2022

Last Updated

June 23, 2023

Sponsor

University of Toronto

Collaborators

University of Saskatchewan, Saskatchewan Food Industry Development Center

1. Study Identification

Unique Protocol Identification Number

NCT05291351

Brief Title

Impact of Pea, Lentil and Oat Flour Particle Size on Glycemic Response in Healthy Adults

Acronym

PLO

Official Title

Comparison of the Impacts of Pea, Lentil, and Oat Flour Particle Size on Postprandial Glycemic Response and Appetite in Healthy Adults

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2022 (Actual)

Primary Completion Date

January 30, 2024 (Anticipated)

Study Completion Date

March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Toronto

Collaborators

University of Saskatchewan, Saskatchewan Food Industry Development Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The study looks at the comparative effects of food products made with pea, lentil, and oat flour of various particle sizes on postprandial glycemic response, appetite and food intake, and amino acid release in healthy adults.

Detailed Description

A total of 60 participants (30 males, 30 females) will take part in this study at the University of Toronto. Twenty participants will be recruited to each one of three trials (pea, lentil or oat) and will attend 4 study sessions where they will consume crackers/porridge made with pea, lentil, oat, or wheat flours of different particle sizes. Questionnaires will be filled out to assess their recent food intake, physical activity, sleep quality, stress level, appetite, physical comfort, and energy/fatigue level, as well as tastefulness of the food. Blood samples will be collected at fasting and at various time points over a 2 hour period after eating to measure blood glucose, insulin, and amino acid concentrations. Before leaving, participants will receive an all-you-can-eat pizza meal to assess their food intake.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malnutrition; Diabetes, Malnutrition; Protein, Obesity

Keywords

Nutrition, Glycemic response, Protein quality, Food processing

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Randomized, controlled, crossover acute trial

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pea

Arm Type

Experimental

Arm Description

Arm Title

Lentil

Arm Type

Experimental

Arm Description

Arm Title

Oats

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Crackers made with whole, coarse, or fine pea and/or wheat flour

Intervention Description

Participants will consume 1 of the 4 treatments at each of 4 study sessions in random orders such that by the end of the study, they will have consumed all 4 treatments. They will be given 10 minutes to consume the entire treatment with a glass of water.

Intervention Type

Other

Intervention Name(s)

Crackers made with whole, coarse, or fine lentil and/or wheat flour

Intervention Description

Intervention Type

Other

Intervention Name(s)

Porridge made with oat flour or oats

Intervention Description

Primary Outcome Measure Information:

Title

Change in postprandial glycemic response

Description

Blood collection via finger prick to analyze blood glucose (glucometer reading) and serum insulin concentration (μIU/mL).

Time Frame

Blood glucose will be measured at baseline and at 15, 30, 45, 60, 90, 120, and 140 minutes after treatment consumption. Insulin will be measured at baseline and every half an hour after treatment consumption over 2 hours.

Secondary Outcome Measure Information:

Title

Subjective appetite

Description

Motivation to Eat Adaptive Visual Analogue Scales measured based on a score between 0 to 100. A higher score indicates higher outcome.

Time Frame

At baseline and at 15, 30, 45, 60, 90, 120, and 140 minutes after treatment consumption.

Title

Food intake

Description

Measured via amount of pizza (g) consumed at an ad libitum pizza meal.

Time Frame

2 hours after treatment consumption.

Title

Protein quality

Description

Intravenous blood collection to analyze amino acid concentrations (μmol/L) to determine amino acid release.

Time Frame

At baseline and every half hour after treatment consumption over a period of 2 hours, and after pizza meal.

Title

Physical comfort

Description

Physical Comfort Visual Analogue Scales measured based on a score between 0 to 100. A higher score indicates higher outcome.

Time Frame

At baseline and at 15, 30, 45, 60, 90, 120, and 140 minutes after treatment consumption.

Title

Energy & fatigue

Description

Energy and Fatigue Visual Analogue Scales measured based on a score between 0 to 100. A higher score indicates higher outcome.

Time Frame

At baseline and at 15, 30, 45, 60, 90, 120, and 140 minutes after treatment consumption.

Title

Treatment palatability

Description

Treatment Palatability Visual Analogue Scales measured based on a score between 0 to 100. A higher score indicates higher outcome.

Time Frame

Immediately after treatment consumption.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18-45 years of age BMI 18.5-29.9 kg/m2 Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial. Willing to maintain current dietary supplement use throughout the trial. Willing to abstain from alcohol consumption for 24h prior to all test visits. Willing to avoid vigorous physical activity for 24h prior to all test visits. Understanding the study procedure and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator. Exclusion Criteria: Smoking Thyroid problems Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, a malabsorptive syndrome, pancreatitis, gallbladder or biliary disease. Presence of a gastrointestinal disorder or surgeries within the past year. Known to be pregnant or lactating. Unwillingness or inability to comply with the experimental procedures and to follow our safety guidelines. Allergies to peanuts and nuts. Known intolerances, sensitivity or allergy to any ingredients in the study products: pea flour, lentil flour, oat flour and whole wheat flour. Regular breakfast skipping (consumes breakfast less than 5 days a week) Extreme dietary habits (i.e Atkins diet, very high protein diets, etc.) or restrained eaters, identified by a score of ≥ 11 on the Eating Habits Questionnaire Uncontrolled hypertension (systolic blood pressure > 140 mm Hg or diastolic blood pressure > 90 mm Hg) as defined by the average blood pressure measured at screening. Weight gain or loss of at least 10lbs in previous three months. Excessive alcohol intake (more than 2 drinks per day or more than 9 drinks per week). Consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect blood glucose or that could affect the outcome of the study as per investigator's judgment.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hrvoje Fabek, PhD

Phone

(416) 978-0799

hrvoje.fabek@utoronto.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Corrina Zhou, BSc, BASc

Phone

6479889657

corrina.zhou@mail.utoronto.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

G. Harvey Anderson, PhD

Organizational Affiliation

University of Toronto

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Nutritional Sciences

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5S 3E2

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hrvoje Fabek, PhD

First Name & Middle Initial & Last Name & Degree

G. Harvey Anderson, PhD

12. IPD Sharing Statement

Plan to Share IPD

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Impact of Pea, Lentil and Oat Flour Particle Size on Glycemic Response in Healthy Adults

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