Effect of Certain Breakfasts on Appetite Control

Study Overview
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Brief Summary
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This clinical trial is being conducted to study whether eating certain meals will reduce your desire to eat and for a longer period of time compared to others and to determine the post-meal glucose response associated with each of these breakfast foods.

Detailed Description
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The study is divided into 3 phases. Each phase involves eating one of 3 different breakfasts every day for 1 month. The order of the breakfast products is random. During each phase participants will come to the research clinic for 4 visits (1 per week) for assessment of appetite-related sensations. Gastric emptying will be assessed at 1 visit per phase and post prandial glucose response will be measured at 1 visit per phase (Asper site only).

Official Title
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A Randomized, Controlled, Cross-over Study of the Effect of Certain Breakfasts on Appetite Control.

Conditions
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Appetite, Post-prandial Glucose Response

Intervention / Treatment
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* Other: breakfast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Males and females (not pregnant or lactating) aged 19 to 60 years. Body mass index: 18.5-30 kg/m2. Exclusion Criteria: A change in medication (dose or type) or medical event requiring hospitalization within the past month. Daily tobacco use. Physical Activity Level >1.8. Eat meals at irregular or unusual times. Food allergy, aversion or unwillingness to eat study foods. Use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect appetite or blood sugar. Presence of a gastrointestinal disorder. Taking drugs that affect gastric emptying. Score >65% on any 1 of the 3 categories of the Three Factor Eating Questionnaire-R18.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 60 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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: breakfast #1<br>breakfast food containing high viscosity fibre | Other: breakfast<br> <br> |
| Experimental: breakfast #2<br>breakfast food containing low viscosity fibre | Other: breakfast<br> <br> |
| Placebo Comparator: Control<br>breakfast food without viscous fibre | Other: breakfast<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satiety | Total area under the curve (AUC) for hunger, fullness, desire to eat, and prospective consumption scales | before the breakfast and every 30 minutes after breakfast for 4 hours | 
| Gastric emptying rate | 13C-Octanoic Acid will be incorporated into the breakfast food. Rate of gastric emptying will be determined by measuring 13C in breath samples. | before the breakfast and every 15 minutes after breakfast for 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose and Insulin | Total area under the curve (iAUC, mmol*min/L) for both glucose and insulin | before the breakfast and at 15, 30, 45, 60, 90 and 120 minutes after the the breakfast. | 
| Kilocalories | Measure the amount of kilocalories consumed throughout each test day. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breakfast, Satiety, Fibre, Glucose, Gastric emptying