Clinical trial NCT05291351: Impact of Pea, Lentil and Oat Flour Particle Size on Glycemic Response in Healthy Adults
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
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition; Diabetes
Malnutrition; Protein
Obesity
Keywords: Nutrition
Glycemic response
Protein quality
Food processing
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: University of Saskatchewan
name: Saskatchewan Food Industry Development Center
First posted: 2022-03-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, controlled, crossover acute trial
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change in postprandial glycemic response
timeFrame: 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 outcomes:
measure: Subjective appetite
timeFrame: At baseline and at 15, 30, 45, 60, 90, 120, and 140 minutes after treatment consumption.
measure: Food intake
timeFrame: 2 hours after treatment consumption.
measure: Protein quality
timeFrame: At baseline and every half hour after treatment consumption over a period of 2 hours, and after pizza meal.
measure: Physical comfort
timeFrame: At baseline and at 15, 30, 45, 60, 90, 120, and 140 minutes after treatment consumption.
measure: Energy & fatigue
timeFrame: At baseline and at 15, 30, 45, 60, 90, 120, and 140 minutes after treatment consumption.
measure: Treatment palatability
timeFrame: Immediately after treatment consumption.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Department of Nutritional Sciences
state: Ontario
Study officials:
affiliation: University of Toronto
name: G. Harvey Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
References: