The Effect of Pulse Flours on Blood Glucose, Satiety and Food Intake
The Effect of Food Formulated With Pulse Flours on Blood Glucose, Satiety and Food Intake
1 other identifier
interventional
54
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2019
Longer than P75 for not_applicable
1 active site
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
Study Start
First participant enrolled
September 16, 2019
CompletedFirst Submitted
Initial submission to the registry
May 2, 2020
CompletedFirst Posted
Study publicly available on registry
May 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedMarch 16, 2023
March 1, 2023
3 years
May 2, 2020
March 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Blood Glucose
The concentration of venous blood glucose before and after each treatment consumption
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
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).
0-120 minutes
Secondary Outcomes (2)
Physical Comfort
0-120 minutes
Palatability of Food
5 minutes
Study Arms (4)
Baked food made of lentil flour
EXPERIMENTALFood prepared with 100% lentil flour
Baked food made of lentil flour and wheat flour
EXPERIMENTALFood prepared with a mixture of lentil flour and wheat flour
Baked food made of wheat flour
EXPERIMENTALFood prepared with 100% wheat flour
Water
EXPERIMENTALPotable water (energy and carbohydrate-free control)
Interventions
Baked food made of lentil flour and wheat flour
Eligibility Criteria
You may qualify if:
- Healthy young male and female adults (19-35 y) with body mass index (BMI) of 20.0-24.9kg/m2
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mount Saint Vincent University
Halifax, Nova Scotia, B3M 2J6, Canada
Study Officials
- PRINCIPAL INVESTIGATOR
Bohdan Luhovyy, PhD
Mount Saint Vincent University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- The participants and investigators are blinded and could not distinguish the food formulated with different flours. The taste and flavour in all treatments were similar due to added flavourings.
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 2, 2020
First Posted
May 7, 2020
Study Start
September 16, 2019
Primary Completion
August 31, 2022
Study Completion
December 31, 2022
Last Updated
March 16, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share