Metabolomic Response to Meal Ingestion

NCT ID: NCT03383250

Last Updated: 2018-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-15

Study Completion Date

2017-10-15

Brief Summary

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The investigators have recently shown that postprandial sensations correlate with changes in circulating metabolites after a meal ingestion; however this phenomenon was demonstrated with a meal load up to the level of tolerance which involved an unpleasant fullness sensation. The aim of the present study is to determine changes in circulating metabolites of a satiating pleasurable meal. Healthy men (n = 32) will be evaluated after a 5 h fast. Perception measurements and blood samples will be taken before and 20 minutes after ingestion of a palatable probe meal (juice and warm ham and cheese sandwich, total 300 ml, 440 kcal). NMR spectroscopy will be performed to determine plasmatic Low Molecular Weight Metabolites (LMWM) and to characterize lipoprotein profiles (number of particles, lipid content and size of the main three lipoprotein classes (VLDL, LDL and HDL). Homeostatic (satiety, fullness) and hedonic sensations (digestive well-being, mood) will be measured by 10 cm analogical scales.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Meal ingestion

Group Type EXPERIMENTAL

Normal meal

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Normal meal

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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PR(AG)338/2016D

Identifier Type: -

Identifier Source: org_study_id

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