Influence of Meal Schedule: Gender Differences

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Probe meal

• Registration Number: NCT03773432
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-13
• Primary Completion: 2018-11-16
• Status Verified: 2018-12
• Study Completion: 2018-12-04
• Study First Submitted: 2018-12-05
• Study First Submitted QC: 2018-12-11
• Last Update Submitted: 2018-12-11
• Study First Posted: 2018-12-12
• Last Update Posted: 2018-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Men	Probe meal	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.
Women	Probe meal	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

University Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain