The Effect of Navy Beans and Yellow Peas on Satiety in Children

Study Overview
=================
Brief Summary
-----------------
The frequent consumption of pulses is associated with multiple cardiometabolic benefits in adults including a lower risk for overweight and obesity. However, it remains unclear whether these effects are mediated through the short-term mechanisms, including enhanced satiety and reduced food intake (FI), or through the long-term metabolic effects triggered by regular consumption of pulses. The objective of this study is to investigate the short-term effect of cooked pulses served in the amount similar to their recommended serving of 175ml (3/4 cup) on food intake in 12-14y children, and gastrointestinal comfort over 2-hours. The secondary objective is to evaluate how children perceive the sensory characteristics of the meals made with the whole pulses.

Official Title
-----------------
The Effect of Cooked Whole Navy Beans and Yellow Peas on Short-term Satiety and Food Intake in Children

Conditions
-----------------
Food, Eating, Satiety, Physical Comfort

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy boys and girls born at full-term do not receive any medications Exclusion Criteria: Food sensitivities or allergies Dietary restrictions Health problems Learning, emotional or behavioral problems.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cooked whole navy beans<br>A meal consisting of cooked navy beans | Other: Food-1<br>* Cooked whole navy beans (300 kcal)<br>|
| Experimental: Cooked whole yellow split peas<br>A meal consisting of cooked yellow peas | Other: Food-2<br>* Cooked whole yellow split peas (300 kcal)<br>|
| Experimental: Cooked rice (control)<br>A meal consisting of cooked rice | Other: Food-3<br>* Cooked rice considered as control (300 kcal)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food intake | The amount of energy (kcal) consumed ad libitum with the breakfast meal or water control and with the test meal (pizza lunch) two hours later. | 120 min | 
| 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 min | 
| Subjective feeling of 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 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective perception of food palatability (pleasantness) | The pleasantness of the meals measured with 100 mm Visual Analogue Scales with two opposite statements at each end (e.g., 0 mm means that food is not pleasant at all, and 100 mm means that the food is very pleasant). | 0, 120 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulses, Satiety, Food intake, Appetite, Beans, Peas