Measurement of Lipogenic Flux by Deuterium Resolved Mass Spectrometry Via Non-invasive Breath Analysis

Study Overview
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Brief Summary
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This proof of concept- study is to measure de novo lipogenesis (DNL) non-invasively in exhaled breath in overnight-fasted humans by triggering feeding response by deuterium resolved mass spectrometry.

Detailed Description
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The study objective is to measure the DNL by ingestion of a single oral dose of 70% 2H2O at 2 g/kg body-water. The subjects will consume a Yoghurt consisting of 300g of 'Excellence Joghurt Nature gezuckert' which contains 410 Kcal, 28g fat, 34g carbohydrates and 9g protein. The exhaled air of the subjects will be measured several times per hour to analyse de novo lipogenesis (DNL) non-invasive by deuterium resolved mass spectrometry.

Official Title
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Measurement of Lipogenic Flux by Deuterium Resolved Mass Spectrometry Via Non-invasive Breath Analysis

Conditions
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De Novo Lipogenesis (DNL)

Intervention / Treatment
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* Other: Assessment of de novo lipogenesis non-invasively in exhaled breath


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult volunteers English speaking, or good knowledge of the English language Able to understand the study Able to give informed consent Exclusion Criteria: Current pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: One arm, Proof of Concept Study assessing metabolites in exhaled breath of healthy adults.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>Assessment of de novo lipogenesis non-invasively in exhaled breath in overnight-fasted humans by triggering feeding response by deuterium resolved mass spectrometry. | Other: Assessment of de novo lipogenesis non-invasively in exhaled breath<br>* Healthy participants have a good nights sleep whereas they don't eat during the night and until measurements. They come to the lab and make first baseline exhalation sets. An exhalation set consists of 6 exhalations in Mass Spectrometer positive mode and the same in negative mode. One exhalation set takes around 7minutes from start to finish. Participants consume a single oral dose of dose of 70% 2H2O at 2 g/kg body-water. Participants execute several exhalation sets over time. Participants consume 300g of 'Excellence Joghurt Nature gezuckert. Participants execute several exhalation sets over time. After around 4.5hours with regular exhalation sets taking place, the trial is concluded.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of signal intensity of deuterated exhaled metabolites across the approximately lasting 4.5 hours trial | Variation of signal intensity of deuterated exhaled metabolites across the approximately lasting 4.5 hours trial | approximately 4.5 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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deuterium resolved mass spectrometry, exhaled breath, deuterium enrichment, metabolome of exhaled breath, deuterated exhaled metabolites