Palatability and Postprandial Sensations

Healthy Clinical Trial

Official title:

Factors to Determine the Responses to Meal Ingestion: Palatability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03134365
• Other study ID #: PR(AG)338/2016C
• Status: Completed
• Phase: N/A
• First received: April 25, 2017
• Last updated: April 25, 2017
• Start date: August 4, 2016
• Est. completion date: December 2, 2016

Study information

• Verified date: April 2017
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim: to determine the effect of palatability on the cognitive (satiation/fullness) and emotive (digestive well-being/mood) responses to meal ingestion. The postprandial responses to conventional (potato and cheese cream followed by vanilla cream) versus unconventional test meals (mixture of both creams) with identical composition (350 Kcal) and physical characteristics (colour, texture, consistency, temperature) but distinctively different palatability will be studied on a cross over-design. The responses to the meals will be tested on 2 different days.

Participants (22 non-obese healthy men) 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 test meal will be administered 5 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2, 2016
• Est. primary completion date: November 23, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Mixed meal
Mixed meal with identical composition and physical characteristics (colour, texture, consistency, temperature) but distinctively different palatability.
• Combined meal
Combined meal.

Locations

Country	Name	City	State
Spain	University Hospital Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Meal palatability	Meal palatability measured by 10 score scales at the end of the test meal	1 day
Primary	Change in digestive well-being measured after the test meal	Change in average well-being measured by 10 score scales at the end of the test meal.	1 day
Secondary	Change in satiety measured after the test meal	Change in average satiety measured by 10 score scales at the end of the test meal	1 day
Secondary	Change in fullness sensation measured after the test meal	Change in average fullness measured by 10 score scales at the end of the test meal	1 day
Secondary	Change in abdominal discomfort/pain sensation measured after the test meal	Change in average abdominal discomfort/pain measured by 10 score scales at the end of the test meal	1 day
Secondary	Change in mood measured after the test meal	Change in average mood measured by 10 score scales at the end of the test meal.	1 day