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Biological Response to Meal Ingestion: Gender Differences

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03758482
Enrollment
24
Registered
2018-11-29
Start date
2018-06-25
Completion date
2018-11-16
Last updated
2018-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

meal ingestion, metabolomic responses, hedonic sensations, homeostatic sensations

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.

Interventions

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

Sponsors

Hospital Universitari Vall d'Hebron Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Fullness sensation induced by the probe meal1 dayGender 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

MeasureTime frameDescription
Change in circulating metabolites induced by the probe meal1 dayChange in low-molecular weight metabolites and lipoproteins analysed using nuclear magnetic resonance.
Change in hunger/satiety induced by the probe meal1 dayGender 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).
Change in digestive well-being induced by the probe meal1 dayGender 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).
Change in mood induced by the probe meal1 dayGender 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).

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026