Effect of Meal Composition on the Responses to Meal Inges... | NCT03084276

Studies
Effect of Meal Composition on the Responses to Meal Ingestion

NCT03084276

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Status

Completed

Last Update Posted

Apr 25, 2017Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

High-fat meal
Low-fat meal

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 16, 2017Actual

Primary Completion Date

Mar 17, 2017Actual

Completion Date

Mar 21, 2017Actual

First Submitted Date

Mar 14, 2017

First Submission Date that Met QC Criteria

Mar 17, 2017

First Posted Date

Mar 20, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2017

Last Update Posted Date

Apr 25, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High-fat meal	Experimental		Other: High-fat meal
Low-fat meal	Active Comparator		Other: Low-fat meal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High-fat meal	Other	High-fat meal	High-fat meal
Low-fat meal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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
Change in fullness sensation measured after the test meal

Other Outcomes

Measure	Description	Time Frame
Meal palatability	Meal palatability measured by 10 score scales at the end of the test meal.	1 day

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Vall d'Hebron		Barcelona		08035	Spain