Blood GlucoseNCT04378374
The Effect of Pulse Flours on Blood Glucose, Satiety and Food Intake
A study testing Food-1, Food-2 and Food-3 in people with Blood Glucose and Eating, run by Mount Saint Vincent University at 1 site in Canada.
Trial summary
Pulse flours represent a fast-growing segment on the functional food market; however, their health effects are not well understood. The observational studies and acute trials have established the link between frequent consumption of cooked whole pulses (beans, peas, lentils and chickpeas) and healthier body weight and… Read more about this study
- Who is it for?
- Ages 19 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose, Eating, Appetite
- What is being tested?
- Food-1, Food-2 and Food-3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteCanada
- Study dates
- 16 Sep 2019to 31 Dec 2022
- 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 19 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy young male and female adults (19-35 y) with body mass index (BMI) of 20.0-24.9kg/m2
Who cannot join
- Breakfast skippers
- Smokers (including e-cigarettes) / cannabis consumers
- Those with BMI < 18.5 and > 24.5 kg/m2
- People with chronic diseases
- People with impaired blood glucose control
- People taking medication that may affect central and peripheral mechanisms of food intake regulation, blood glucose control, cognitive performance and sedative medication.
- People with intellectual disabilities (excluded due to their inability to comprehend hedonic and visual analogue scales used in the study).
- People with food allergies or gastrointestinal disorders (e.g., IBS and others).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Food Formulated With Pulse Flours on Blood Glucose, Satiety and Food Intake
Pulse flours represent a fast-growing segment on the functional food market; however, their health effects are not well understood. The observational studies and acute trials have established the link between frequent consumption of cooked whole pulses (beans, peas, lentils and chickpeas) and healthier body weight and improved blood glucose control. However, it is not clear whether these effects still remain after the processing of pulses into flours. The investigators hypothesized that the baked food products formulated with lentil flour of the same particle size as all-purpose wheat flour may reduce postprandial glycaemia and elicit a stronger suppression of subjective appetite due to its higher content of protein and resistant carbohydrate compared to all-purpose wheat flour. The treatments will be formulated either with lentil flour or with all-purpose wheat flour of similar particle size or with their combination. The objective of the project is to test the effect of foods formulated with lentil flour and/or wheat flour on blood glucose, short-term food intake and subjective appetite.
- Conditions
- Blood Glucose, Eating, Appetite, Food
- Being tested
- Food-1, Food-2, Food-3, Food-4
- Keywords
- Pulses, Flour, Food Intake, Satiety, Blood Glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food-1Other
Baked food made of lentil flour
Food-2Other
Baked food made of lentil flour and wheat flour
Food-3Other
Baked food made of wheat flour
Food-4Other
Potable water (energy and carbohydrate-free control)
| Study group | Role | What they receive |
|---|---|---|
| Baked food made of lentil flour | Experimental | Food prepared with 100% lentil flour Receives: Other: Food-1 |
| Baked food made of lentil flour and wheat flour | Experimental | Food prepared with a mixture of lentil flour and wheat flour Receives: Other: Food-2 |
| Baked food made of wheat flour | Experimental | Food prepared with 100% wheat flour Receives: Other: Food-3 |
| Water | Experimental | Potable water (energy and carbohydrate-free control) Receives: Other: Food-4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose
The concentration of venous blood glucose before and after each treatment consumption
Measured: 0-120 minutes
Food Intake
The amount of energy (kcal) consumed ad libitum at the test meal (pizza lunch) two hours after each treatment consumption
Measured: 120 minutes
Subjective Appetite
The subjective assessment of appetite parameters including desire to eat, fullness, hunger and a prospective food consumption measured with 100 mm Visual Analogue Scales with two opposite statements at each end (e.g., for the hunger scale, 0 mm means not hungry at all, and 100 mm means very hungry).
Measured: 0-120 minutes
Secondary outcomes (2)
Physical Comfort
The subjective assessment of wellness and gastrointestinal symptoms including a feeling of nausea, diarrhea, flatulence, and other parameters measured with 100 mm Visual Analogue Scales with two opposite statements at each end.
Measured: 0-120 minutes
Palatability of Food
The palatability of the treatments will be measured immediately after consumption with a 100 mm Visual Analogue Scale with two opposite statements at each end or with a 9-point hedonic scale.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start16 Sep 2019
- Primary completion31 Aug 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood GlucoseStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Saint Vincent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bohdan Luhovyy, Mount Saint Vincent University
- Investigators
- Bohdan Luhovyy, PhD, Principal investigator, Mount Saint Vincent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378374
- Sponsor's protocol ID
- 2018-201
- Status last verified
- Mar 2023
- First submitted
- 2 May 2020
- Last updated
- 16 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Food Formulated With Pulse Flours on Blood Glucose, Satiety and Food Intake
- ClinicalTrials.gov ID
- NCT04378374
- Acronym / sponsor ID
- 2018-201
- Conditions
- Blood Glucose, Eating, Appetite, Food
- Keywords
- Pulses, Flour, Food Intake, Satiety, Blood Glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Mount Saint Vincent UniversityUniversity, hospital or other
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 7 May 2020 (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.
Pulse flours represent a fast-growing segment on the functional food market; however, their health effects are not well understood. The observational studies and acute trials have established the link between frequent consumption of cooked whole pulses (beans, peas, lentils and chickpeas) and healthier body weight and improved blood glucose control. However, it is not clear whether these effects still remain after the processing of pulses into flours. The investigators hypothesized that the baked food products formulated with lentil flour of the same particle size as all-purpose wheat flour may reduce postprandial glycaemia and elicit a stronger suppression of subjective appetite due to its higher content of protein and resistant carbohydrate compared to all-purpose wheat flour. The treatments will be formulated either with lentil flour or with all-purpose wheat flour of similar particle size or with their combination. The objective of the project is to test the effect of foods formulated with lentil flour and/or wheat flour on blood glucose, short-term food intake and subjective appetite.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Baked food made of lentil flour | Experimental | Other: Food-1Food prepared with 100% lentil flour |
| Baked food made of lentil flour and wheat flour | Experimental | Other: Food-2Food prepared with a mixture of lentil flour and wheat flour |
| Baked food made of wheat flour | Experimental | Other: Food-3Food prepared with 100% wheat flour |
| Water | Experimental | Other: Food-4Potable water (energy and carbohydrate-free control) |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy young male and female adults (19-35 y) with body mass index (BMI) of 20.0-24.9kg/m2
Key exclusion criteria (8 listed)
- Breakfast skippers
- Smokers (including e-cigarettes) / cannabis consumers
- Those with BMI < 18.5 and > 24.5 kg/m2
- People with chronic diseases
- People with impaired blood glucose control
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 |
|---|---|---|
| Food-1Baked food made of lentil flour | Other | Baked food made of lentil flour |
| Food-2Baked food made of lentil flour and wheat flour | Other | Baked food made of lentil flour and wheat flour |
| Food-3Baked food made of wheat flour | Other | Baked food made of wheat flour |
| Food-4Potable water (energy and carbohydrate-free control) | Other | Water |
Primary outcome
Blood Glucose
Time frame: 0-120 minutes
The concentration of venous blood glucose before and after each treatment consumption
Food Intake
Time frame: 120 minutes
The amount of energy (kcal) consumed ad libitum at the test meal (pizza lunch) two hours after each treatment consumption
Subjective Appetite
Time frame: 0-120 minutes
The subjective assessment of appetite parameters including desire to eat, fullness, hunger and a prospective food consumption measured with 100 mm Visual Analogue Scales with two opposite statements at each end (e.g., for the hunger scale, 0 mm means not hungry at all, and 100 mm means very hungry).
2 secondary outcomes
Physical Comfort
Time frame: 0-120 minutes
Palatability of Food
Time frame: 5 minutes
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 16 Mar 2023.
- 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.
Bohdan Luhovyy, PhD principal investigator
Mount Saint Vincent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food-1, Food-2 and Food-3 in people with Blood Glucose and Eating, run by Mount Saint Vincent University 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 1 inclusion and 8 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 16 Mar 2023. 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?
Blood Glucose (time frame: 0-120 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2023.