Effect of Education on the Responses to Meal Ingestion

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT02997917
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study First Submitted: 2016-12-16
• Study First Submitted QC: 2016-12-16
• Study First Posted: 2016-12-20
• Study Completion: 2017-01
• Last Update Submitted: 2017-02-03
• Last Update Posted: 2017-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in digestive well-being measured after a test meal by the end of the intervention versus before.	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 Outcome Measures

Name	Time	Method
Change in satiety measured after a test meal by the end of the intervention versus before	1 day	Change in average satiety measured by 0-10 score scales at the end of the test meal administered before and after intervention.
Change in fullness sensation measured after a test meal by the end of the intervention versus before.	1 day	Change in average fullness measured by 0-10 score scales at the end of the test meal administered before and after intervention.
Change in discomfort/pain measured after a test meal by the end of the intervention versus before	1 day	Change in average fullness measured by 0-10 score scales at the end of the test meal administered before and after intervention.

Trial Locations

Locations (1)

Fernando Azpiroz; 🇪🇸 Barcelona, Spain