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

Study Overview
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Brief Summary
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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.

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

Conditions
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Blood Glucose, Eating, Appetite, Food

Intervention / Treatment
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* Other: Food-1
* Other: Food-2
* Other: Food-3
* Other: Food-4


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baked food made of lentil flour<br>Food prepared with 100% lentil flour | Other: Food-1<br>* Baked food made of lentil flour<br>|
| Experimental: Baked food made of lentil flour and wheat flour<br>Food prepared with a mixture of lentil flour and wheat flour | Other: Food-2<br>* Baked food made of lentil flour and wheat flour<br>|
| Experimental: Baked food made of wheat flour<br>Food prepared with 100% wheat flour | Other: Food-3<br>* Baked food made of wheat flour<br>|
| Experimental: Water<br>Potable water (energy and carbohydrate-free control) | Other: Food-4<br>* Potable water (energy and carbohydrate-free control)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulses, Flour, Food Intake, Satiety, Blood Glucose