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

NCT ID: NCT05274334

Last Updated: 2022-11-04

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

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-11

Study Completion Date

2022-09-30

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.

Conditions

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De Novo Lipogenesis (DNL)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

One arm, Proof of Concept Study assessing metabolites in exhaled breath of healthy adults.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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intervention group

Assessment of de novo lipogenesis non-invasively in exhaled breath in overnight-fasted humans by triggering feeding response by deuterium resolved mass spectrometry.

Group Type EXPERIMENTAL

Assessment of de novo lipogenesis non-invasively in exhaled breath

Intervention Type OTHER

1. Healthy participants have a good nights sleep whereas they don't eat during the night and until measurements.
2. 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.
3. Participants consume a single oral dose of dose of 70% 2H2O at 2 g/kg body-water.
4. Participants execute several exhalation sets over time.
5. Participants consume 300g of 'Excellence Joghurt Nature gezuckert.
6. Participants execute several exhalation sets over time.
7. After around 4.5hours with regular exhalation sets taking place, the trial is concluded.

Interventions

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Assessment of de novo lipogenesis non-invasively in exhaled breath

1. Healthy participants have a good nights sleep whereas they don't eat during the night and until measurements.
2. 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.
3. Participants consume a single oral dose of dose of 70% 2H2O at 2 g/kg body-water.
4. Participants execute several exhalation sets over time.
5. Participants consume 300g of 'Excellence Joghurt Nature gezuckert.
6. Participants execute several exhalation sets over time.
7. After around 4.5hours with regular exhalation sets taking place, the trial is concluded.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Swiss National Science Foundation

OTHER

Sponsor Role collaborator

Fondation Botnar

UNKNOWN

Sponsor Role collaborator

University Children's Hospital Basel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pablo Sinues, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitäts-Kinderspital beider Basel (UKBB)

Locations

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University Children's Hospital Basel (UKBB)

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2022-00099; ks22Sinues

Identifier Type: -

Identifier Source: org_study_id

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