Measurement of Lipogenic Flux by Deuterium Resolved Mass Spectrometry Via Non-invasive Breath Analysis (D2OBREATH)

November 3, 2022 updated by: University Children's Hospital Basel
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4056
        • University Children's Hospital Basel (UKBB)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.

What is the study measuring?

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
Time Frame: approximately 4.5 hours
Variation of signal intensity of deuterated exhaled metabolites across the approximately lasting 4.5 hours trial
approximately 4.5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Children's Hospital Basel

Collaborators

Swiss National Science Foundation
Fondation Botnar

Investigators

  • Principal Investigator: Pablo Sinues, Prof. Dr., Universitäts-Kinderspital beider Basel (UKBB)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2022

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

March 1, 2022

First Submitted That Met QC Criteria

March 1, 2022

First Posted (Actual)

March 10, 2022

Study Record Updates

Last Update Posted (Actual)

November 4, 2022

Last Update Submitted That Met QC Criteria

November 3, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022-00099; ks22Sinues

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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