Effect of Ambient Noise on the Responses to Meal Ingestion

Sponsor

Hospital Universitari Vall d'Hebron Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT03827707

Collaborator

(none)

Enrollment

Location

Arms

4.2

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Behavioral: Noise Behavioral: Silence	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Oct 18, 2018

Actual Primary Completion Date :

Feb 8, 2019

Actual Study Completion Date :

Feb 22, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Noise	Behavioral: Noise Noise applied via headphones during 60 min after meal ingestion
Sham Comparator: Silence	Behavioral: Silence Headphones without sound applied during 60 min after meal ingestion

Arm

Intervention/Treatment

Experimental: Noise

Behavioral: Noise

Noise applied via headphones during 60 min after meal ingestion

Sham Comparator: Silence

Behavioral: Silence

Headphones without sound applied during 60 min after meal ingestion

Outcome Measures

Primary Outcome Measures

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

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 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).
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Vall d'Hebron	Barcelona		Spain	08035

Sponsors and Collaborators

Hospital Universitari Vall d'Hebron Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Pribic T, Azpiroz F. Biogastronomy: Factors that determine the biological response to meal ingestion. Neurogastroenterol Motil. 2018 Jul;30(7):e13309. doi: 10.1111/nmo.13309. Epub 2018 Feb 2. Review.

Responsible Party:

Hospital Universitari Vall d'Hebron Research Institute

ClinicalTrials.gov Identifier:

NCT03827707

Other Study ID Numbers:

PR(AG)338/2016H

First Posted:

Feb 1, 2019

Last Update Posted:

Mar 22, 2019

Last Verified:

Nov 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute

meal ingestion

postprandial responses

hedonic sensations

homeostatic sensations

ambient noise

Study Results

No Results Posted as of Mar 22, 2019