Effect of Meal Composition on the Responses to Meal Ingestion

Study Overview
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Brief Summary
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Aim: to determine to what extent meal composition influences postprandial sensations independently of palatability. The postprandial responses to a low-fat (240 Kcal) versus a high-fat (275 Kcal) test meal (150 g humus) with the same physical and organoleptic characteristics (taste, smell, colour, texture, consistency, temperature) will be studied on a cross-over design. The responses to the meals will be tested on 2 different days. Participants (12 non-obese healthy men) will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the test meal will be administered 3 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Perception will be measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min intervals up to 60 min after the probe meal.

Official Title
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Factors That Determine the Responses to Meal Ingestion: Meal Composition

Conditions
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Healthy

Intervention / Treatment
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* Other: High-fat meal
* Other: Low-fat meal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: non-obese Exclusion Criteria: history of gastrointestinal symptoms prior obesity use of medications history of anosmia and ageusia current dieting alcohol abuse psychological disorders eating disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-fat meal<br> | Other: High-fat meal<br>* High-fat meal<br>|
| Active Comparator: Low-fat meal<br> | Other: Low-fat meal<br>* Low-fat meal with the same physical and organoleptic characteristics as the high-calorie meal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in digestive well-being measured after the test meal | Change in average well-being measured by 10 score scales at the end of the test meal. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in satiety measured after the test meal | Change in average satiety measured by 10 score scales at the end of the test meal | 1 day | 
| Change in fullness sensation measured after the test meal | Change in average fullness measured by 10 score scales at the end of the test meal | 1 day | 
| Change in abdominal discomfort/pain sensation measured after the test meal | Change in average abdominal discomfort/pain measured by 10 score scales at the end of the test meal | 1 day | 
| Change in mood measured after the test meal | Change in average mood measured by 10 score scales at the end of the test meal. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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meal ingestion, meal composition, postprandial responses, hedonic sensations, homeostatic sensations, new composition