De Novo Lipogenesis (DNL)D2OBREATHNCT05274334
Measurement of Lipogenic Flux by Deuterium Resolved Mass Spectrometry Via Non-invasive Breath Analysis
A study testing Assessment of de novo lipogenesis non-invasively in exhaled breath in people with De Novo Lipogenesis (DNL), run by University Children's Hospital Basel at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- De Novo Lipogenesis (DNL)
- What is being tested?
- Assessment of de novo lipogenesis non-invasively in exhaled breath
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 May 2022to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult volunteers
- English speaking, or good knowledge of the English language
- Able to understand the study
- Able to give informed consent
Who cannot join
- Current pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- De Novo Lipogenesis (DNL)
- Being tested
- Assessment of de novo lipogenesis non-invasively in exhaled breath
- Keywords
- deuterium resolved mass spectrometry, exhaled breath, deuterium enrichment, metabolome of exhaled breath, deuterated exhaled metabolites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of de novo lipogenesis non-invasively in exhaled breathOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Assessment of de novo lipogenesis non-invasively in exhaled breath |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: approximately 4.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start11 May 2022
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for De Novo Lipogenesis (DNL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One arm, Proof of Concept Study assessing metabolites in exhaled breath of healthy adults.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital Basel
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, Fondation Botnar
- Responsible party
- Sponsor
- Investigators
- Pablo Sinues, Prof. Dr., Principal investigator, Universitäts-Kinderspital beider Basel (UKBB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274334
- Sponsor's protocol ID
- 2022-00099; ks22Sinues
- Acronym
- D2OBREATH
- Status last verified
- Nov 2022
- First submitted
- 1 Mar 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Lipogenic Flux by Deuterium Resolved Mass Spectrometry Via Non-invasive Breath Analysis
- ClinicalTrials.gov ID
- NCT05274334
- Acronym / sponsor ID
- D2OBREATH / 2022-00099; ks22Sinues
- Conditions
- De Novo Lipogenesis (DNL)
- Keywords
- deuterium resolved mass spectrometry, exhaled breath, deuterium enrichment, metabolome of exhaled breath, deuterated exhaled metabolites
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Children's Hospital BaselUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, Fondation Botnar
- Study start
- 11 May 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One arm, Proof of Concept Study assessing metabolites in exhaled breath of healthy adults.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Assessment of de novo lipogenesis non-invasively in exhaled breathAssessment of de novo lipogenesis non-invasively in exhaled breath in overnight-fasted humans by triggering feeding response by deuterium resolved mass spectrometry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy adult volunteers
- English speaking, or good knowledge of the English language
- Able to understand the study
- Able to give informed consent
Key exclusion criteria (1 listed)
- Current pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of de novo lipogenesis non-invasively in exhaled breath1. 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. | Other | intervention group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Sinues, Prof. Dr. principal investigator
Universitäts-Kinderspital beider Basel (UKBB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of de novo lipogenesis non-invasively in exhaled breath in people with De Novo Lipogenesis (DNL), run by University Children's Hospital Basel at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of signal intensity of deuterated exhaled metabolites across the approximately lasting 4.5 hours trial (time frame: approximately 4.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.