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Clinical Trials/NCT03827707
NCT03827707
Completed
Not Applicable

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

Hospital Universitari Vall d'Hebron Research Institute1 site in 1 country12 target enrollmentOctober 18, 2018
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Enrollment
12
Locations
1
Primary Endpoint
Change in digestive well-being induced by the probe meal
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 18, 2018
End Date
February 22, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • Change in fullness sensation induced by the probe meal(1 day)
  • Change in hunger/satiety induced by the probe meal(1 day)
  • Change in mood induced by the probe meal(1 day)

Study Sites (1)

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