Influence of Meal Schedule: Gender Differences

Sponsor

Hospital Universitari Vall d'Hebron Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT03773432

Collaborator

(none)

Enrollment

Location

Arms

3.7

Actual Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Gender differences in the effect of meal schedule will be studied in a parallel design (10 women and 10 men). In two separate days a probe meal (290 stewed beans, 35 g bread, 100 mL water; 549 Kcal) will be administered in the afternoon, i.e. conventional schedule, and in the morning, i.e. unconventional schedule. The effect of meal schedule will be measured as the differences between the responses on both study days. Participants will be instructed to eat standard dinner the day before and to consume standard breakfast at home the day of the afternoon test. Studies will be conducted in a quiet, isolated room with participants siting 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Probe meal	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Factors That Determine the Responses to Meal Ingestion: Meal Schedule and Gender Differences

Actual Study Start Date :

Aug 13, 2018

Actual Primary Completion Date :

Nov 16, 2018

Actual Study Completion Date :

Dec 4, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Men In two separate days a probe meal (290 stewed beans, 35 g bread, 100 mL water; 549 Kcal) will be served at conventional and unconventional time.	Other: Probe meal The probe meal will be administered either in the afternoon (conventional schedule) or in the morning (unconventional schedule).
Other: Women In two separate days a probe meal (290 stewed beans, 35 g bread, 100 mL water; 549 Kcal) will be served at conventional and unconventional time.	Other: Probe meal The probe meal will be administered either in the afternoon (conventional schedule) or in the morning (unconventional schedule).

Arm

Intervention/Treatment

Other: Men

In two separate days a probe meal (290 stewed beans, 35 g bread, 100 mL water; 549 Kcal) will be served at conventional and unconventional time.

Other: Probe meal

The probe meal will be administered either in the afternoon (conventional schedule) or in the morning (unconventional schedule).

Other: Women

In two separate days a probe meal (290 stewed beans, 35 g bread, 100 mL water; 549 Kcal) will be served at conventional and unconventional time.

Other: Probe meal

The probe meal will be administered either in the afternoon (conventional schedule) or in the morning (unconventional schedule).

Outcome Measures

Primary Outcome Measures

Change in digestive well-being induced by meal schedule [1 day]
Change in digestive well-being measured by a 10 cm scale graded from -5 (extremely unpleasant sensation) to +5 (extremely pleasant sensation) in response to afternoon and morning meals by repeated measures ANCOVA.

Secondary Outcome Measures

Change in fullness sensation induced by meal schedule [1 day]
Change in digestive well-being measured by a 10 cm scale graded from 0 (not at all) to 10 (very much) in response to afternoon and morning meals by repeated measures ANCOVA.
Change in mood induced by meal schedule [1 day]
Change in mood measured by a 10 cm scale graded from -5 (negative) to +5 (positive) in response to afternoon and morning meals by repeated measures ANCOVA.
Change in hunger/satiety induced by meal schedule [1 day]
Change in mood measured by a 10 cm scale graded from -5 (extremely hungry) to +5 (completely satiate) in response to afternoon and morning meals by repeated measures ANCOVA.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Vall d'Hebron	Barcelona		Spain	08035

Sponsors and Collaborators

Hospital Universitari Vall d'Hebron Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Pribic T, Azpiroz F. Biogastronomy: Factors that determine the biological response to meal ingestion. Neurogastroenterol Motil. 2018 Jul;30(7):e13309. doi: 10.1111/nmo.13309. Epub 2018 Feb 2. Review.

Responsible Party:

Hospital Universitari Vall d'Hebron Research Institute

ClinicalTrials.gov Identifier:

NCT03773432

Other Study ID Numbers:

PR(AG)338/2016G

First Posted:

Dec 12, 2018

Last Update Posted:

Dec 12, 2018

Last Verified:

Dec 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute

meal ingestion

meal schedule

postprandial responses

hedonic sensations

homeostatic sensations

Study Results

No Results Posted as of Dec 12, 2018