Malnutrition; DiabetesPLONCT05291351
Impact of Pea, Lentil and Oat Flour Particle Size on Glycemic Response in Healthy Adults
A study testing Crackers made with whole, coarse, or fine pea and/or wheat flour, Crackers made with whole, coarse, or fine lentil and/or wheat flour and Porridge made with oat flour in people with Malnutrition; Diabetes and Malnutrition; Protein, run by University of Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition; Diabetes, Malnutrition; Protein, Obesity
- What is being tested?
- Crackers made with whole, coarse, or fine pea and/or wheat flour, Crackers made with whole, coarse, or fine lentil and/or wheat flour and Porridge made with oat flour
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Impacts of Pea, Lentil, and Oat Flour Particle Size on Postprandial Glycemic Response and Appetite in Healthy Adults
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.
Read the 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
- Being tested
- Crackers made with whole, coarse, or fine pea and/or wheat flour, Crackers made with whole, coarse, or fine lentil and/or wheat flour, Porridge made with oat flour
- Keywords
- Nutrition, Glycemic response, Protein quality, Food processing
- Medical subject headings
- Malnutrition, Diabetes Mellitus, Kwashiorkor, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crackers made with whole, coarse, or fine pea and/or wheat flourOther
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 flourOther
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 flourOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: Other: Porridge made with oat flour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postprandial glycemic response
Blood collection via finger prick to analyze blood glucose (glucometer reading) and serum insulin concentration (μIU/mL).
Measured: 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
Motivation to Eat Adaptive Visual Analogue Scales measured based on a score between 0 to 100. A higher score indicates higher outcome.
Measured: At baseline and at 15, 30, 45, 60, 90, 120, and 140 minutes after treatment consumption.
Food intake
Measured via amount of pizza (g) consumed at an ad libitum pizza meal.
Measured: 2 hours after treatment consumption.
Protein quality
Intravenous blood collection to analyze amino acid concentrations (μmol/L) to determine amino acid release.
Measured: At baseline and every half hour after treatment consumption over a period of 2 hours, and after pizza meal.
Physical comfort
Physical Comfort Visual Analogue Scales measured based on a score between 0 to 100. A higher score indicates higher outcome.
Measured: At baseline and at 15, 30, 45, 60, 90, 120, and 140 minutes after treatment consumption.
Energy & fatigue
Energy and Fatigue Visual Analogue Scales measured based on a score between 0 to 100. A higher score indicates higher outcome.
Measured: At baseline and at 15, 30, 45, 60, 90, 120, and 140 minutes after treatment consumption.
Treatment palatability
Treatment Palatability Visual Analogue Scales measured based on a score between 0 to 100. A higher score indicates higher outcome.
Measured: Immediately after treatment consumption.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start1 Apr 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malnutrition; DiabetesStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, controlled, crossover acute trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University of Saskatchewan, Saskatchewan Food Industry Development Center
- Responsible party
- Principal investigator, G. Harvey Anderson, University of Toronto
- Investigators
- G. Harvey Anderson, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291351
- Sponsor's protocol ID
- 20180182
- Acronym
- PLO
- Status last verified
- Jul 2024
- First submitted
- 28 Feb 2022
- Last updated
- 5 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39366276
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Impacts of Pea, Lentil, and Oat Flour Particle Size on Postprandial Glycemic Response and Appetite in Healthy Adults
- ClinicalTrials.gov ID
- NCT05291351
- Acronym / sponsor ID
- PLO / 20180182
- Conditions
- Malnutrition; Diabetes, Malnutrition; Protein, Obesity
- Keywords
- Nutrition, Glycemic response, Protein quality, Food processing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- University of Saskatchewan, Saskatchewan Food Industry Development Center
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 22 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized, controlled, crossover acute trial
| Arm | Type | Receives |
|---|---|---|
| Pea | Experimental | Other: Crackers made with whole, coarse, or fine pea and/or wheat flourTreatment 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) |
| Lentil | Experimental | Other: Crackers made with whole, coarse, or fine lentil and/or wheat flourTreatment 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) |
| Oats | Experimental | Other: Porridge made with oat flourTreatment 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) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crackers made with whole, coarse, or fine pea and/or wheat flourParticipants 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. | Other | Pea |
| Crackers made with whole, coarse, or fine lentil and/or wheat flourParticipants 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. | Other | Lentil |
| Porridge made with oat flourParticipants 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. | Other | Oats |
Primary outcome
Change in postprandial glycemic response
Time frame: 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.
Blood collection via finger prick to analyze blood glucose (glucometer reading) and serum insulin concentration (μIU/mL).
6 secondary outcomes
Subjective appetite
Time frame: At baseline and at 15, 30, 45, 60, 90, 120, and 140 minutes after treatment consumption.
Food intake
Time frame: 2 hours after treatment consumption.
Protein quality
Time frame: At baseline and every half hour after treatment consumption over a period of 2 hours, and after pizza meal.
Physical comfort
Time frame: At baseline and at 15, 30, 45, 60, 90, 120, and 140 minutes after treatment consumption.
Energy & fatigue
Time frame: At baseline and at 15, 30, 45, 60, 90, 120, and 140 minutes after treatment consumption.
Treatment palatability
Time frame: Immediately after treatment consumption.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Derived from this study: PubMed 39366276Zhou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
G. Harvey Anderson, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crackers made with whole, coarse, or fine pea and/or wheat flour, Crackers made with whole, coarse, or fine lentil and/or wheat flour and Porridge made with oat flour in people with Malnutrition; Diabetes and Malnutrition; Protein, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in postprandial glycemic response (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05291351, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.