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Clinical Trials/NCT02997917
NCT02997917
Completed
Not Applicable

Factors That Determine the Response to Meal Ingested: Education

Hospital Universitari Vall d'Hebron Research Institute1 site in 1 country28 target enrollmentNovember 2016
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Enrollment
28
Locations
1
Primary Endpoint
Change in digestive well-being measured after a test meal by the end of the intervention versus before.
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The effect of education on the responses to a probe meal (250 mL vegetable soup cooked at low temperature and 25 g bread) will be studied in a parallel design. The effects of education will be tested in two different groups in random order: real versus sham education. In each group the responses to a probe meal will be tested on 2 different days before and after the intervention. Participants 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 probe meal will be administered 3 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Perception 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
November 2016
End Date
January 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
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 measured after a test meal by the end of the intervention versus before.

Time Frame: 1 day

Change in average well-being measured by 0-10 score scales at the end of the test meal administered before and after intervention.

Secondary Outcomes

  • Change in satiety measured after a test meal by the end of the intervention versus before(1 day)
  • Change in fullness sensation measured after a test meal by the end of the intervention versus before.(1 day)
  • Change in discomfort/pain measured after a test meal by the end of the intervention versus before(1 day)

Study Sites (1)

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