Metabolomic Response to Meal Ingestion

Factors to Determine the Responses to Meal Ingestion: Circulating Metabolites

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Normal meal

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Meal ingestion	Dietary supplement: Normal meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Metabolomic response in serum	30 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in digestive well-being measured after the test meal	Change in average well-being measured by 10 score scales at the end of the test meal.	1 day
Change in satiety measured after the test meal	Change in average satiety measured by 10 score scales at the end of the test meal	1 day
Change in fullness sensation measured after the test meal	Change in average fullness measured by 10 score scales at the end of the test meal	1 day
Change in abdominal discomfort/pain sensation measured after the test meal	Change in average abdominal discomfort/pain measured by 10 score scales at the end of the test meal	1 day
Change in mood measured after the test meal	Change in average mood measured by 10 score scales at the end of the test meal.	1 day

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2014
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): October 15, 2017

Study Registration Dates

• First Submitted: December 19, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (Actual): December 26, 2017

Study Record Updates

• Last Update Posted (Actual): January 4, 2018
• Last Update Submitted That Met QC Criteria: January 3, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: circulating metabolites; meal ingestion; postprandial sensations
• Other Study ID Numbers: PR(AG)338/2016D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No