Meal Enjoyment and Tolerance: Sex Differences | NCT03408977

Studies
Meal Enjoyment and Tolerance: Sex Differences

NCT03408977

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Status

Completed

Last Update Posted

Feb 26, 2018Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

probe 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

Jan 2018

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

Sep 1, 2017Actual

Primary Completion Date

Dec 20, 2017Actual

Completion Date

Jan 8, 2018Actual

First Submitted Date

Jan 18, 2018

First Submission Date that Met QC Criteria

Jan 18, 2018

First Posted Date

Jan 24, 2018Actual

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

Feb 23, 2018

Last Update Posted Date

Feb 26, 2018Actual

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 the effect of gender on the responses to meal ingestion. Participants (10 men and 10 women) 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 4 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Participants will ingest a probe meal up to the level of maximal satiation. The probe meal will be served stepwise (150 Kcal every 5 min). Perception of homeostatic (hunger/satiation, fullness) and hedonic (digestive well-being, mood) sensations will be measured at 5 min intervals 10 min before, during and 20 min after ingestion at 10 min intervals.

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Men	Experimental		Other: probe meal
Women	Experimental		Other: probe meal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
probe meal	Other	The probe meal will be served in 150 Kcal portions (10 g foie, 10 g cheese, 5 g chips, 2 g peanuts, 3 g toast, and 27 mL soft drink) up to the level of maximal satiation.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Meal tolerance	Amount of meal (Kcal) consumed up to the level of maximal satiation (score 5 on a - 5 to + 5 score hunger/satiation scale).	100 min

Secondary Outcomes

Measure	Description	Time Frame
Change in digestive well-being induced by the probe meal	Change in well-being measured by 10 score scales during and after the probe meal.	1 day
Change in fullness sensation induced by the probe meal

Other Outcomes

Not provided

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

All

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