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

NCT05274334 | Completed

• 1 other identifier: 2022-00099; ks22Sinues
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

De Novo Lipogenesis (DNL)

Keywords

deuterium resolved mass spectrometry; exhaled breath; deuterium enrichment; metabolome of exhaled breath; deuterated exhaled metabolites

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

intervention group

EXPERIMENTAL

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

Interventions

Assessment of de novo lipogenesis non-invasively in exhaled breath 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.

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult volunteers
• English speaking, or good knowledge of the English language
• Able to understand the study
• Able to give informed consent

You may not qualify if:

• Current pregnancy

Sponsors & Collaborators

• University Children's Hospital Basel: lead
• Swiss National Science Foundation: collaborator
• Fondation Botnar: collaborator

Study Sites (1)

University Children's Hospital Basel (UKBB)

Basel, 4056, Switzerland

Location

Study Officials

• Pablo Sinues, Prof. Dr.

  Universitäts-Kinderspital beider Basel (UKBB)

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: One arm, Proof of Concept Study assessing metabolites in exhaled breath of healthy adults.

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 10, 2022
• Study Start: May 11, 2022
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-11

Locations

CH (1)