NCT05291351

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 22, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 5, 2024

Status Verified

July 1, 2024

Enrollment Period

1.8 years

First QC Date

February 28, 2022

Last Update Submit

July 2, 2024

Conditions

Keywords

NutritionGlycemic responseProtein qualityFood processing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Subjective appetite

    At baseline and at 15, 30, 45, 60, 90, 120, and 140 minutes after treatment consumption.

  • Food intake

    2 hours after treatment consumption.

  • Protein quality

    At baseline and every half hour after treatment consumption over a period of 2 hours, and after pizza meal.

  • Physical comfort

    At baseline and at 15, 30, 45, 60, 90, 120, and 140 minutes after treatment consumption.

  • Energy & fatigue

    At baseline and at 15, 30, 45, 60, 90, 120, and 140 minutes after treatment consumption.

  • +1 more secondary outcomes

Study Arms (3)

Pea

EXPERIMENTAL

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

Lentil

EXPERIMENTAL

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

Oats

EXPERIMENTAL

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)

Other: Porridge made with oat flour

Interventions

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.

Pea

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

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

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutritional Sciences

Toronto, Ontario, M5S 3E2, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

MalnutritionDiabetes MellitusKwashiorkorObesity

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesSevere Acute MalnutritionOverweightOvernutritionBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • G. Harvey Anderson, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Randomized, controlled, crossover acute trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 28, 2022

First Posted

March 22, 2022

Study Start

April 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

July 5, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations