NCT03383250

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 26, 2017

Completed
Last Updated

January 4, 2018

Status Verified

December 1, 2017

Enrollment Period

2.6 years

First QC Date

December 19, 2017

Last Update Submit

January 3, 2018

Conditions

Healthy

Keywords

meal ingestionpostprandial sensationscirculating metabolites

Outcome Measures

Primary Outcomes (1)

  • Metabolomic response in serum

    30 min

Secondary Outcomes (5)

  • Change in digestive well-being measured after the test meal

    1 day

  • Change in satiety measured after the test meal

    1 day

  • Change in fullness sensation measured after the test meal

    1 day

  • Change in abdominal discomfort/pain sensation measured after the test meal

    1 day

  • Change in mood measured after the test meal

    1 day

Study Arms (1)

Meal ingestion

EXPERIMENTAL
Dietary Supplement: Normal meal

Interventions

Normal mealDIETARY_SUPPLEMENT
Meal ingestion

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2017

First Posted

December 26, 2017

Study Start

November 15, 2014

Primary Completion

June 30, 2017

Study Completion

October 15, 2017

Last Updated

January 4, 2018

Record last verified: 2017-12