The Effect of Pulse Flours on Blood Glucose, Satiety and Food Intake

Blood Glucose Clinical Trial

Official title:

The Effect of Food Formulated With Pulse Flours on Blood Glucose, Satiety and Food Intake

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04378374
• Other study ID #: 2018-201
• Status: Completed
• Phase: N/A
• Start date: September 16, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: Mount Saint Vincent University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 35 Years

Eligibility

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).

Related Conditions & MeSH terms

• Appetite
• Blood Glucose
• Eating
• Food

Intervention

Other:
• Food-1
Baked food made of lentil flour
• Food-2
Baked food made of lentil flour and wheat flour
• Food-3
Baked food made of wheat flour
• Food-4
Potable water (energy and carbohydrate-free control)

Locations

Country	Name	City	State
Canada	Mount Saint Vincent University	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Mount Saint Vincent University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Glucose	The concentration of venous blood glucose before and after each treatment consumption	0-120 minutes
Primary	Food Intake	The amount of energy (kcal) consumed ad libitum at the test meal (pizza lunch) two hours after each treatment consumption	120 minutes
Primary	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	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.	0-120 minutes
Secondary	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.	5 minutes