- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04378374
The Effect of Pulse Flours on Blood Glucose, Satiety and Food Intake
March 14, 2023 updated by: Bohdan Luhovyy, Mount Saint Vincent University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3M 2J6
- Mount Saint Vincent University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy young male and female adults (19-35 y) with body mass index (BMI) of 20.0-24.9kg/m2
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Baked food made of lentil flour
Food prepared with 100% lentil flour
|
Baked food made of lentil flour
|
Experimental: Baked food made of lentil flour and wheat flour
Food prepared with a mixture of lentil flour and wheat flour
|
Baked food made of lentil flour and wheat flour
|
Experimental: Baked food made of wheat flour
Food prepared with 100% wheat flour
|
Baked food made of wheat flour
|
Experimental: Water
Potable water (energy and carbohydrate-free control)
|
Potable water (energy and carbohydrate-free control)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood Glucose
Time Frame: 0-120 minutes
|
The concentration of venous blood glucose before and after each treatment consumption
|
0-120 minutes
|
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
|
120 minutes
|
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).
|
0-120 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Comfort
Time Frame: 0-120 minutes
|
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.
|
0-120 minutes
|
Palatability of Food
Time Frame: 5 minutes
|
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.
|
5 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bohdan Luhovyy, PhD, Mount Saint Vincent University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 16, 2019
Primary Completion (Actual)
August 31, 2022
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
May 2, 2020
First Submitted That Met QC Criteria
May 5, 2020
First Posted (Actual)
May 7, 2020
Study Record Updates
Last Update Posted (Actual)
March 16, 2023
Last Update Submitted That Met QC Criteria
March 14, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2018-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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