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Effect of Ambient Noise on the Responses to Meal Ingestion

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ClinicalTrials.gov Identifier: NCT03827707
Recruitment Status : Completed
First Posted : February 1, 2019
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : October 18, 2018
Actual Primary Completion Date : February 8, 2019
Actual Study Completion Date : February 22, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Noise

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Change in digestive well-being induced by the probe meal [ Time Frame: 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 :
  1. Change in fullness sensation induced by the probe meal [ Time Frame: 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).

  2. Change in mood induced by the probe meal [ Time Frame: 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).

  3. Change in hunger/satiety induced by the probe meal [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827707


Locations
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Spain
University Hospital Vall d'Hebron
Barcelona, Spain, 08035
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
More Information
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Publications:

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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT03827707    
Other Study ID Numbers: PR(AG)338/2016H
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
meal ingestion
postprandial responses
hedonic sensations
homeostatic sensations
ambient noise