Influence of Meal Schedule: Gender Differences
Factors That Determine the Responses to Meal Ingestion: Meal Schedule and Gender Differences
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Aug 2018
Shorter than P25 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 16, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 4, 2018
CompletedFirst Submitted
Initial submission to the registry
December 5, 2018
CompletedFirst Posted
Study publicly available on registry
December 12, 2018
CompletedDecember 12, 2018
December 1, 2018
3 months
December 5, 2018
December 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in digestive well-being induced by meal schedule
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.
1 day
Secondary Outcomes (3)
Change in fullness sensation induced by meal schedule
1 day
Change in mood induced by meal schedule
1 day
Change in hunger/satiety induced by meal schedule
1 day
Study Arms (2)
Men
OTHERIn 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
OTHERIn 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.
Interventions
The probe meal will be administered either in the afternoon (conventional schedule) or in the morning (unconventional schedule).
Eligibility Criteria
You may qualify if:
- non-obese
You may not qualify if:
- history of gastrointestinal symptoms
- prior obesity
- use of medications
- history of anosmia and ageusia
- current dieting
- alcohol abuse
- psychological disorders
- eating disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Vall d'Hebron
Barcelona, 08035, Spain
Related Publications (1)
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.
PMID: 29392797BACKGROUND
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2018
First Posted
December 12, 2018
Study Start
August 13, 2018
Primary Completion
November 16, 2018
Study Completion
December 4, 2018
Last Updated
December 12, 2018
Record last verified: 2018-12