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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
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

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

Experimental

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

First Posted
February 28, 2022
Last Updated
June 23, 2023
Sponsor
University of Toronto
Collaborators
University of Saskatchewan, Saskatchewan Food Industry Development Center
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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
No
Studies a U.S. FDA-regulated Device Product
No

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
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)
Arm Title
Lentil
Arm Type
Experimental
Arm Description
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)
Arm Title
Oats
Arm Type
Experimental
Arm Description
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)
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
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)
Porridge made with oat flour or oats
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.
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
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
Email
hrvoje.fabek@utoronto.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Corrina Zhou, BSc, BASc
Phone
6479889657
Email
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
No

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

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