Biological Response to Meal Ingestion: Gender Differences

Study Overview
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Brief Summary
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Aim: to determine the effect of gender on the sensory and metabolomic responses to a standard probe meal. Participants (12 men and 12 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 standard probe meal (750 Kcal). Perception of homeostatic sensations (hunger/satiation, fullness) and hedonic sensations (digestive well-being, mood) 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. Heart rate variability, blood pressure and body temperature were measured before and after the meal. Blood samples for metabolomic analysis were taken before and 30 min after the meal.

Official Title
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Factors That Determine the Responses to Meal Ingestion: Effect of Gender on Sensory and Metabolomic Responses

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Men<br>The probe meal consists of: 50 g fatty liver duck, 15 g toasts, 50 g cheese, 25 g potato chips, 10 g salted peanuts and 140 mL soft drink. | Other: Probe meal<br>* The probe meal (total caloric content 750 Kcal) will be ingested at a standard rate in 10 min.<br>|
| Other: Women<br>The probe meal consists of: 50 g fatty liver duck, 15 g toasts, 50 g cheese, 25 g potato chips, 10 g salted peanuts and 140 mL soft drink. | Other: Probe meal<br>* The probe meal (total caloric content 750 Kcal) will be ingested at a standard rate in 10 min.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fullness sensation induced by the probe meal | Gender differences in fullness sensation [(measured by a 10 cm scale graded from 0 (not at all) to 10 (very much)] by repeated measures ANCOVA (dependent variable: postprandial sensations scores; between and within subject's factors: gender and time, respectively; covariate: premeal scores). | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hunger/satiety induced by the probe meal | Gender differences in hunger/satiety [(measured by a 10 cm scale graded from -5 (extremely hungry) to +5 (completely satiate)] by repeated measures ANCOVA (dependent variable: postprandial sensations scores; between and within subject's factors: gender and time, respectively; covariate: premeal scores). | 1 day | 
| Change in digestive well-being induced by the probe meal | Gender differences in digestive well-being [(measured by a 10 cm scale graded from -5 (extremely unpleasant sensation) to +5 (extremely pleasant sensation)] by repeated measures ANCOVA (dependent variable: postprandial sensations scores; between and within subject's factors: gender and time, respectively; covariate: premeal scores). | 1 day | 
| Change in mood induced by the probe meal | Gender differences in mood [(measured by a 10 cm scale graded from -5 (negative) to +5 (postive)] by repeated measures ANCOVA (dependent variable: postprandial sensations scores; between and within subject's factors: gender and time, respectively; covariate: premeal scores). | 1 day | 
| Change in circulating metabolites induced by the probe meal | Change in low-molecular weight metabolites and lipoproteins analysed using nuclear magnetic resonance. | 1 day | 

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