Skip to main content
OpenTrials
Completed

NCT Number: NCT03758482

Biological Response to Meal Ingestion: Gender Differences

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Vall d'Hebron

Barcelona, 08035, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probe meal

Other

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

Primary outcomes

  1. Fullness sensation induced by the probe meal

    Time frame: 1 day

    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).

Secondary outcomes

  1. Change in hunger/satiety induced by the probe meal

    Time frame: 1 day

    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).

  2. Change in digestive well-being induced by the probe meal

    Time frame: 1 day

    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).

  3. Change in mood induced by the probe meal

    Time frame: 1 day

    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).

  4. Change in circulating metabolites induced by the probe meal

    Time frame: 1 day

    Change in low-molecular weight metabolites and lipoproteins analysed using nuclear magnetic resonance.

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 29, 2018
Registry last updated
Nov 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.