Effect of Education on the Responses to Meal Ingestion

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Behavioral: Education; Behavioral: Sham

• 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

Arm && Interventions

Group	Intervention	Description
Education	Education	Solutions of the five basic tastes (sweet, salty, sour, bitter and umami) and the 3 main components of the probe soup (onion, leek and carrot) will be given every 10 min with a mouthwash after each test. In the real education group, solutions at suprathreshold concentration for detection will be given with a subsequent comment on the flavor and an explanation of the components and preparation of the soup (low temperature cooking to preserve flavors).
Sham	Sham	Solutions of the five basic tastes (sweet, salty, sour, bitter and umami) and the 3 main components of the probe soup (onion, leek and carrot) will be given every 10 min with a mouthwash after each test. In the sham education group solutions at subthreshold concentration for detection with no explanation will be provided.

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