Effect of Ambient Noise on the Responses to Meal Ingestion

Study Overview
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Brief Summary
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Meal ingestion induces sensations that are influenced by a series of conditioning factors. Aim: to determine the effect of ambient noise on the sensory responses to a standard probe meal. Randomized, cross-over study in healthy subjects comparing the effect of ambient noise versus silence on the sensations induced by a probe meal. Participants (12 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 5 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. One study day, a noise will applied via headphones for 60 min after meal ingestion and the other day headphones without sound will applied. 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.

Official Title
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Factors That Determine the Responses to Meal Ingestion: Effect of Ambient Noise

Conditions
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Healthy

Intervention / Treatment
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* Behavioral: Noise
* Behavioral: Silence


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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Noise<br> | Behavioral: Noise<br>* Noise applied via headphones during 60 min after meal ingestion<br>|
| Sham Comparator: Silence<br> | Behavioral: Silence<br>* Headphones without sound applied during 60 min after meal ingestion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in digestive well-being induced by the probe meal | Effect of noise on 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; within subject's factors: noise and time; covariate: premeal scores). | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fullness sensation induced by the probe meal | Effect of noise on fullness [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; within subject's factors: noise and time; covariate: premeal scores). | 1 day | 
| Change in mood induced by the probe meal | Effect of noise on mood [measured by a 10 cm scale graded from -5 (negative) to +5 (positive)] by repeated measures ANCOVA (dependent variable: postprandial sensations scores; within subject's factors: noise and time; covariate: premeal scores). | 1 day | 
| Change in hunger/satiety induced by the probe meal | Effect of noise on 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; within subject's factors: noise and time; covariate: premeal scores). | 1 day | 

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