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OpenTrials
Completed

NCT Number: NCT03383250

Metabolomic Response to Meal Ingestion

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.

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Key information

Conditions

Healthy

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

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

Normal meal

Dietary Supplement

Primary outcomes

  1. Metabolomic response in serum

    Time frame: 30 min

Secondary outcomes

  1. Change in digestive well-being measured after the test meal

    Time frame: 1 day

    Change in average well-being measured by 10 score scales at the end of the test meal.

  2. Change in satiety measured after the test meal

    Time frame: 1 day

    Change in average satiety measured by 10 score scales at the end of the test meal

  3. Change in fullness sensation measured after the test meal

    Time frame: 1 day

    Change in average fullness measured by 10 score scales at the end of the test meal

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

    Time frame: 1 day

    Change in average abdominal discomfort/pain measured by 10 score scales at the end of the test meal

  5. Change in mood measured after the test meal

    Time frame: 1 day

    Change in average mood measured by 10 score scales at the end of the test meal.

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

Factors to Determine the Responses to Meal Ingestion: Circulating Metabolites

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 26, 2017
Registry last updated
Jan 4, 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.

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