Meal Enjoyment and Tolerance: Sex Differences

Study Overview
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Brief Summary
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Aim: to determine the effect of gender on the responses to meal ingestion. Participants (10 men and 10 women) 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 4 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Participants will ingest a probe meal up to the level of maximal satiation. The probe meal will be served stepwise (150 Kcal every 5 min). Perception of homeostatic (hunger/satiation, fullness) and hedonic (digestive well-being, mood) sensations will be measured at 5 min intervals 10 min before, during and 20 min after ingestion at 10 min intervals.

Official Title
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Factors That Determine the Responses to Meal Ingestion: Sex Differences

Conditions
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Healthy

Intervention / Treatment
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* Other: probe 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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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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Men<br> | Other: probe meal<br>* The probe meal will be served in 150 Kcal portions (10 g foie, 10 g cheese, 5 g chips, 2 g peanuts, 3 g toast, and 27 mL soft drink) up to the level of maximal satiation.<br>|
| Experimental: Women<br> | Other: probe meal<br>* The probe meal will be served in 150 Kcal portions (10 g foie, 10 g cheese, 5 g chips, 2 g peanuts, 3 g toast, and 27 mL soft drink) up to the level of maximal satiation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meal tolerance | Amount of meal (Kcal) consumed up to the level of maximal satiation (score 5 on a - 5 to + 5 score hunger/satiation scale). | 100 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in digestive well-being induced by the probe meal | Change in well-being measured by 10 score scales during and after the probe meal. | 1 day | 
| Change in fullness sensation induced by the probe meal | Change in fullness sensation measured by 10 score scales during and after the probe meal. | 1 day | 
| Change in mood induced by the probe meal | Change in mood measured by 10 score scales during and after the probe meal. | 1 day | 
| Change in abdominal discomfort induced by the probe meal | Change in abdominal discomfort measured by 10 score scales during and after the probe meal. | 1 day | 
| Change in hunger/satiety induced by the probe meal | Change in hunger/satiety measured by 10 score scales during and after the probe 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 tolerance, postprandial responses, hedonic sensations, homeostatic sensations