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

NCT ID: NCT05291351

Last Updated: 2024-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2023-12-31

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.

Conditions

Malnutrition; Diabetes; Malnutrition; Protein; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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.

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)

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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.

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 commercial oat flour (control)

Group Type: EXPERIMENTAL

Porridge made with oat flour

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Porridge made with oat 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Saskatchewan

OTHER

Sponsor Role: collaborator

Saskatchewan Food Industry Development Center

UNKNOWN

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: lead

Responsible Party

G. Harvey Anderson

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

G. Harvey Anderson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

Department of Nutritional Sciences

Toronto, Ontario, Canada

Countries

Canada

References

Zhou CZC, Anderson GH, Fan W, Vien S, Ai Y, Tulbek M, Fabek H. Increasing particle size of oat flours decreases postprandial glycemia and increases appetite in healthy adults. Nutr Res. 2024 Oct;130:81-94. doi: 10.1016/j.nutres.2024.07.006. Epub 2024 Jul 25.

Reference Type: DERIVED

PMID: 39366276 (View on PubMed)

Other Identifiers

20180182

Identifier Type: -

Identifier Source: org_study_id