Effect of Ambient Noise on the Responses to Meal Ingestion
Factors That Determine the Responses to Meal Ingestion: Effect of Ambient Noise
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Oct 2018
Shorter than P25 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 18, 2018
CompletedFirst Submitted
Initial submission to the registry
January 31, 2019
CompletedFirst Posted
Study publicly available on registry
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 22, 2019
CompletedMarch 22, 2019
November 1, 2018
4 months
January 31, 2019
March 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Change in fullness sensation induced by the probe meal
1 day
Change in mood induced by the probe meal
1 day
Change in hunger/satiety induced by the probe meal
1 day
Study Arms (2)
Noise
EXPERIMENTALSilence
SHAM COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- non-obese
You may not qualify if:
- history of gastrointestinal symptoms
- prior obesity
- use of medications
- history of anosmia and ageusia
- current dieting
- alcohol abuse
- psychological disorders
- eating disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Vall d'Hebron
Barcelona, 08035, Spain
Related Publications (1)
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.
PMID: 29392797BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2019
First Posted
February 1, 2019
Study Start
October 18, 2018
Primary Completion
February 8, 2019
Study Completion
February 22, 2019
Last Updated
March 22, 2019
Record last verified: 2018-11