Effect of Education on the Responses to Meal Ingestion

Study Overview
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Brief Summary
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The effect of education on the responses to a probe meal (250 mL vegetable soup cooked at low temperature and 25 g bread) will be studied in a parallel design. The effects of education will be tested in two different groups in random order: real versus sham education. In each group the responses to a probe meal will be tested on 2 different days before and after the intervention. Participants 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 probe 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 Response to Meal Ingested: Education

Conditions
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Healthy

Intervention / Treatment
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* Behavioral: Education
* Behavioral: Sham


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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Education<br>Solutions of the five basic tastes (sweet, salty, sour, bitter and umami) and the 3 main components of the probe soup (onion, leek and carrot) will be given every 10 min with a mouthwash after each test. In the real education group, solutions at suprathreshold concentration for detection will be given with a subsequent comment on the flavor and an explanation of the components and preparation of the soup (low temperature cooking to preserve flavors). | Behavioral: Education<br> <br> |
| Sham Comparator: Sham<br>Solutions of the five basic tastes (sweet, salty, sour, bitter and umami) and the 3 main components of the probe soup (onion, leek and carrot) will be given every 10 min with a mouthwash after each test. In the sham education group solutions at subthreshold concentration for detection with no explanation will be provided. | Behavioral: Sham<br> <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 a test meal by the end of the intervention versus before. | Change in average well-being measured by 0-10 score scales at the end of the test meal administered before and after intervention. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in satiety measured after a test meal by the end of the intervention versus before | Change in average satiety measured by 0-10 score scales at the end of the test meal administered before and after intervention. | 1 day | 
| Change in fullness sensation measured after a test meal by the end of the intervention versus before. | Change in average fullness measured by 0-10 score scales at the end of the test meal administered before and after intervention. | 1 day | 
| Change in discomfort/pain measured after a test meal by the end of the intervention versus before | Change in average fullness measured by 0-10 score scales at the end of the test meal administered before and after intervention. | 1 day |