Influence of Meal Schedule: Gender Differences

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03773432
• Other study ID #: PR(AG)338/2016G
• Status: Completed
• Phase: N/A
• Start date: August 13, 2018
• Est. completion date: December 4, 2018

Study information

• Verified date: December 2018
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 4, 2018
• Est. primary completion date: November 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Spain	University Hospital Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in fullness sensation induced by meal schedule	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.	1 day
Secondary	Change in mood induced by meal schedule	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.	1 day
Secondary	Change in hunger/satiety induced by meal schedule	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.	1 day