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

Sponsor

University of Toronto (Other)

Overall Status

Recruiting

CT.gov ID

NCT05291351

Collaborator

University of Saskatchewan (Other), Saskatchewan Food Industry Development Center (Other)

Enrollment

Location

Arms

14.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Malnutrition; Diabetes Malnutrition; Protein Obesity	Other: Crackers made with whole, coarse, or fine pea and/or wheat flour Other: Crackers made with whole, coarse, or fine lentil and/or wheat flour Other: Porridge made with oat flour or oats	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Randomized, controlled, crossover acute trialRandomized, controlled, crossover acute trial

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Prevention

Official Title:

Comparison of the Impacts of Pea, Lentil, and Oat Flour Particle Size on Glycemic Response, Protein Quality, and Food Intake in Healthy Adults

Actual Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pea 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)	Other: Crackers made with whole, coarse, or fine pea and/or wheat flour 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.
Experimental: Lentil 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)	Other: Crackers made with whole, coarse, or fine lentil and/or wheat flour 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.
Experimental: Oats 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 whole oats (control)	Other: Porridge made with oat flour or oats 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.

Arm

Intervention/Treatment

Experimental: Pea

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)

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

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.

Experimental: Lentil

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)

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

Experimental: Oats

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 whole oats (control)

Other: Porridge made with oat flour or oats

Outcome Measures

Primary Outcome Measures

Change in glycemic response [Blood glucose will be measured at baseline and at 15, 30, 45, 60, 90, 120 minutes after treatment consumption. Insulin will be measured at baseline and every half an hour after treatment consumption over 2 hours.]
Blood collection via finger prick to analyze blood glucose (glucometer reading) and serum insulin concentration (μIU/mL).

Secondary Outcome Measures

Protein quality [At baseline and every half hour after treatment consumption over a period of 2 hours.]
Intravenous blood collection to analyze amino acid concentrations (μmol/L) to determine amino acid release.
Food intake [2 hours after treatment consumption.]
Measured via amount of pizza (g) consumed at an ad libitum pizza meal.
Subjective appetite [At baseline and at 15, 30, 45, 60, 90, and 120 minutes after treatment consumption.]
Motivation to Eat Adaptive Visual Analogue Scales measured based on a score between 0 to 100. A higher score indicates higher outcome.
Physical comfort [At baseline and at 15, 30, 45, 60, 90, and 120 minutes after treatment consumption.]
Physical Comfort Visual Analogue Scales measured based on a score between 0 to 100. A higher score indicates higher outcome.
Energy & fatigue [At baseline and at 15, 30, 45, 60, 90, and 120 minutes after treatment consumption.]
Energy and Fatigue Visual Analogue Scales measured based on a score between 0 to 100. A higher score indicates higher outcome.
Treatment palatability [Immediately after treatment consumption.]
Treatment Palatability Visual Analogue Scales measured based on a score between 0 to 100. A higher score indicates higher outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.