Biological Response to Meal Ingestion: Gender Differences

Healthy Clinical Trial

Official title:

Factors That Determine the Responses to Meal Ingestion: Effect of Gender on Sensory and Metabolomic Responses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03758482
• Other study ID #: PR(AG)338/2016F
• Status: Completed
• Phase: N/A
• Start date: June 25, 2018
• Est. completion date: November 16, 2018

Study information

• Verified date: November 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 sensory and metabolomic responses to a standard probe meal. Participants (12 men and 12 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 standard probe meal (750 Kcal). Perception of homeostatic sensations (hunger/satiation, fullness) and hedonic sensations (digestive well-being, mood) 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. Heart rate variability, blood pressure and body temperature were measured before and after the meal. Blood samples for metabolomic analysis were taken before and 30 min after the meal.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 16, 2018
• Est. primary completion date: September 28, 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 (total caloric content 750 Kcal) will be ingested at a standard rate in 10 min.

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	Fullness sensation induced by the probe meal	Gender differences in fullness sensation [(measured by a 10 cm scale graded from 0 (not at all) to 10 (very much)] by repeated measures ANCOVA (dependent variable: postprandial sensations scores; between and within subject's factors: gender and time, respectively; covariate: premeal scores).	1 day
Secondary	Change in hunger/satiety induced by the probe meal	Gender differences in hunger/satiety [(measured by a 10 cm scale graded from -5 (extremely hungry) to +5 (completely satiate)] by repeated measures ANCOVA (dependent variable: postprandial sensations scores; between and within subject's factors: gender and time, respectively; covariate: premeal scores).	1 day
Secondary	Change in digestive well-being induced by the probe meal	Gender differences in digestive well-being [(measured by a 10 cm scale graded from -5 (extremely unpleasant sensation) to +5 (extremely pleasant sensation)] by repeated measures ANCOVA (dependent variable: postprandial sensations scores; between and within subject's factors: gender and time, respectively; covariate: premeal scores).	1 day
Secondary	Change in mood induced by the probe meal	Gender differences in mood [(measured by a 10 cm scale graded from -5 (negative) to +5 (postive)] by repeated measures ANCOVA (dependent variable: postprandial sensations scores; between and within subject's factors: gender and time, respectively; covariate: premeal scores).	1 day
Secondary	Change in circulating metabolites induced by the probe meal	Change in low-molecular weight metabolites and lipoproteins analysed using nuclear magnetic resonance.	1 day