Effect of Ambient Noise on the Responses to Meal Ingestion

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Behavioral: Silence; Behavioral: Noise

• Registration Number: NCT03827707
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-18
• Status Verified: 2018-11
• Study First Submitted: 2019-01-31
• Study First Submitted QC: 2019-01-31
• Study First Posted: 2019-02-01
• Primary Completion: 2019-02-08
• Study Completion: 2019-02-22
• Last Update Submitted: 2019-03-20
• Last Update Posted: 2019-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Silence	Silence	-
Noise	Noise	-

Primary Outcome Measures

Name	Time	Method
Change in digestive well-being induced by the probe meal	1 day	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).

Secondary Outcome Measures

Name	Time	Method
Change in fullness sensation induced by the probe meal	1 day	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).
Change in hunger/satiety induced by the probe meal	1 day	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).
Change in mood induced by the probe meal	1 day	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).

Trial Locations

Locations (1)

University Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain