Effect of Ambient Noise on the Responses to Meal Ingestion

NCT ID: NCT03827707

Last Updated: 2019-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-18

Study Completion Date

2019-02-22

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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Noise

Group Type EXPERIMENTAL

Noise

Intervention Type BEHAVIORAL

Noise applied via headphones during 60 min after meal ingestion

Silence

Group Type SHAM_COMPARATOR

Silence

Intervention Type BEHAVIORAL

Headphones without sound applied during 60 min after meal ingestion

Interventions

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Noise

Noise applied via headphones during 60 min after meal ingestion

Intervention Type BEHAVIORAL

Silence

Headphones without sound applied during 60 min after meal ingestion

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital Vall d'Hebron

Barcelona, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 29392797 (View on PubMed)

Other Identifiers

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PR(AG)338/2016H

Identifier Type: -

Identifier Source: org_study_id

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