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

Obesity Clinical Trial

— PLO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05291351
• Other study ID #: 20180182
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: March 30, 2024

Study information

• Verified date: June 2023
• Source: University of Toronto
• Contact: Hrvoje Fabek, PhD
• Phone: (416) 978-0799
• Email: hrvoje.fabek[@]utoronto.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kwashiorkor
• Malnutrition
• Malnutrition; Diabetes
• Malnutrition; Protein
• Obesity

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Canada	Department of Nutritional Sciences	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University of Toronto	Saskatchewan Food Industry Development Center, University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in postprandial glycemic response	Blood collection via finger prick to analyze blood glucose (glucometer reading) and serum insulin concentration (µIU/mL).	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	Subjective appetite	Motivation to Eat Adaptive Visual Analogue Scales measured based on a score between 0 to 100. A higher score indicates higher outcome.	At baseline and at 15, 30, 45, 60, 90, 120, and 140 minutes after treatment consumption.
Secondary	Food intake	Measured via amount of pizza (g) consumed at an ad libitum pizza meal.	2 hours after treatment consumption.
Secondary	Protein quality	Intravenous blood collection to analyze amino acid concentrations (µmol/L) to determine amino acid release.	At baseline and every half hour after treatment consumption over a period of 2 hours, and after pizza meal.
Secondary	Physical comfort	Physical Comfort Visual Analogue Scales measured based on a score between 0 to 100. A higher score indicates higher outcome.	At baseline and at 15, 30, 45, 60, 90, 120, and 140 minutes after treatment consumption.
Secondary	Energy & fatigue	Energy and Fatigue Visual Analogue Scales measured based on a score between 0 to 100. A higher score indicates higher outcome.	At baseline and at 15, 30, 45, 60, 90, 120, and 140 minutes after treatment consumption.
Secondary	Treatment palatability	Treatment Palatability Visual Analogue Scales measured based on a score between 0 to 100. A higher score indicates higher outcome.	Immediately after treatment consumption.