Effect of Meal Composition on the Responses to Meal Ingestion

Healthy Clinical Trial

Official title:

Factors That Determine the Responses to Meal Ingestion: Meal Composition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03084276
• Other study ID #: PR(AG)338/2016B
• Status: Completed
• Phase: N/A
• First received: March 14, 2017
• Last updated: April 24, 2017
• Start date: January 16, 2017
• Est. completion date: March 21, 2017

Study information

• Verified date: March 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 to what extent meal composition influences postprandial sensations independently of palatability. The postprandial responses to a low-fat (240 Kcal) versus a high-fat (275 Kcal) test meal (150 g humus) with the same physical and organoleptic characteristics (taste, smell, colour, texture, consistency, temperature) will be studied on a cross-over design. The responses to the meals will be tested on 2 different days. Participants (12 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 21, 2017
• Est. primary completion date: March 17, 2017
• 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:
• High-fat meal
High-fat meal
• Low-fat meal
Low-fat meal with the same physical and organoleptic characteristics as the high-calorie 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
Other	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