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Completed

NCT Number: NCT02997917

Effect of Education on the Responses to Meal Ingestion

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.

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Key information

Conditions

Healthy

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Fernando Azpiroz

Barcelona, 08035, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education

Behavioral

Sham

Behavioral

Primary outcomes

  1. 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

  1. Change in satiety measured after a test meal by the end of the intervention versus before

    Time frame: 1 day

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

  2. Change in fullness sensation measured after a test meal by the end of the intervention versus before.

    Time frame: 1 day

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

  3. Change in discomfort/pain measured after a test meal by the end of the intervention versus before

    Time frame: 1 day

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

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

Factors That Determine the Response to Meal Ingested: Education

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Dec 20, 2016
Registry last updated
Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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