MedDataX Logo

Influence of Meal Schedule: Gender Differences

NCT ID: NCT03773432

Last Updated: 2018-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-13

Study Completion Date

2018-12-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

meal ingestion meal schedule postprandial responses hedonic sensations homeostatic sensations

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

Probe meal

Intervention Type OTHER

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

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.

Group Type OTHER

Probe meal

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Probe meal

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Vall d'Hebron

Barcelona, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 29392797 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PR(AG)338/2016G

Identifier Type: -

Identifier Source: org_study_id