Effect of Education on the Responses to Meal Ingestion

NCT02997917 | Completed

• 1 other identifier: PR(AG)338/2016A
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Change in digestive well-being measured after a test meal by the end of the intervention versus before.

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

  1 day

Secondary Outcomes (3)

• 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 Arms (2)

Education

EXPERIMENTAL

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).

Behavioral: Education

Sham

SHAM COMPARATOR

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.

Behavioral: Sham

Interventions

Education BEHAVIORAL

Education

Sham BEHAVIORAL

Sham

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Fernando Azpiroz

Barcelona, 08035, Spain

Location

MeSH Terms

Interventions

Educational Status; salicylhydroxamic acid

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Fernando Azpiroz, MD

  University Hospital Vall d'Hebron

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: December 20, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: February 6, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)