Meal Enjoyment and Tolerance: Sex Differences

Healthy Clinical Trial

Official title:

Factors That Determine the Responses to Meal Ingestion: Sex Differences

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03408977
• Other study ID #: PR(AG)338/2016E
• Status: Completed
• Phase: N/A
• First received: January 18, 2018
• Last updated: February 23, 2018
• Start date: September 1, 2017
• Est. completion date: January 8, 2018

Study information

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

Clinical Trial Summary

Aim: to determine the effect of gender on the responses to meal ingestion. Participants (10 men and 10 women) will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the test meal will be administered 4 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Participants will ingest a probe meal up to the level of maximal satiation. The probe meal will be served stepwise (150 Kcal every 5 min). Perception of homeostatic (hunger/satiation, fullness) and hedonic (digestive well-being, mood) sensations will be measured at 5 min intervals 10 min before, during and 20 min after ingestion at 10 min intervals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 8, 2018
• Est. primary completion date: December 20, 2017
• 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 served in 150 Kcal portions (10 g foie, 10 g cheese, 5 g chips, 2 g peanuts, 3 g toast, and 27 mL soft drink) up to the level of maximal satiation.

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Meal tolerance	Amount of meal (Kcal) consumed up to the level of maximal satiation (score 5 on a - 5 to + 5 score hunger/satiation scale).	100 min
Secondary	Change in digestive well-being induced by the probe meal	Change in well-being measured by 10 score scales during and after the probe meal.	1 day
Secondary	Change in fullness sensation induced by the probe meal	Change in fullness sensation measured by 10 score scales during and after the probe meal.	1 day
Secondary	Change in mood induced by the probe meal	Change in mood measured by 10 score scales during and after the probe meal.	1 day
Secondary	Change in abdominal discomfort induced by the probe meal	Change in abdominal discomfort measured by 10 score scales during and after the probe meal.	1 day
Secondary	Change in hunger/satiety induced by the probe meal	Change in hunger/satiety measured by 10 score scales during and after the probe meal.	1 day