Biological Response to Meal Ingestion: Gender Differences

NCT03758482 | Completed

• 1 other identifier: PR(AG)338/2016F
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

meal ingestion; metabolomic responses; hedonic sensations; homeostatic sensations

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in hunger/satiety induced by the probe meal

  1 day

• Change in digestive well-being induced by the probe meal

  1 day

• Change in mood induced by the probe meal

  1 day

• Change in circulating metabolites induced by the probe meal

  1 day

Study Arms (2)

Men

OTHER

The probe meal consists of: 50 g fatty liver duck, 15 g toasts, 50 g cheese, 25 g potato chips, 10 g salted peanuts and 140 mL soft drink.

Other: Probe meal

Women

OTHER

The probe meal consists of: 50 g fatty liver duck, 15 g toasts, 50 g cheese, 25 g potato chips, 10 g salted peanuts and 140 mL soft drink.

Other: Probe meal

Interventions

Probe meal OTHER

The probe meal (total caloric content 750 Kcal) will be ingested at a standard rate in 10 min.

Men; Women

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

University Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

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: 29392797 RESULT

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: November 16, 2018
• First Posted: November 29, 2018
• Study Start: June 25, 2018
• Primary Completion: September 28, 2018
• Study Completion: November 16, 2018
• Last Updated: November 29, 2018

Record last verified: 2018-11

Locations

ES (1)