FastingACEXNCT03390881
Use of Breath Acetone aa a Marker of Energy Balance
A study testing Fasting condition, Sugar condition and Fat condition in people with Fasting and Fed, run by University of Lausanne at 1 site in Switzerland.
Trial summary
This study aims at assessing whether breath acetone concentration is a good bio-marker of instantaneous energy balance in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- What is being tested?
- Fasting condition, Sugar condition and Fat condition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2016to Jun 2017
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 19.5-29.9 kg/m2,
- Healthy
Who cannot join
- any known disease (with the exception of allergies);
- consumption of alcohol > 40 g/day;
- any current drug treatment (with the exception of contraceptive agents, antihistaminergic drugs for allergies, or multivitamin supplementations),
- history of lactose intolerance,
- history of exercise intolerance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Validity of Breath Acetone Concentration as a Bio-marker of Instantaneous Energy Balance in Healthy Subjects
This study aims at assessing whether breath acetone concentration is a good bio-marker of instantaneous energy balance in healthy subjects.
Read the detailed description
Each participant will be studied on three occasions, separated by 1-4 weeks. Each evaluation will consist in the same set of metabolic measurements, but will be performed fasting or during administration of a 70% fat or 70% carbohydrate liquid diet, according to a randomized order.
On each occasion, subjects will consume a standardized dinner the day before the experiment. They will remain fasted since 10 pm until the test day.
On the day of the experiments, one venous cannula will be inserted into a forearm vein for the collection of blood samples. An indirect calorimetry (measurement of respiratory gas exchanges using a ventilated canopy at rest, or a face mask during exercise) will be performed throughout the 6-hour test to measure energy expenditure and net substrate oxidation rate. Blood samples will be obtained every 60 min for the measurement of plasma glucose, insulin, free fatty acids, and beta-hydroxybutyrate concentrations. Breath samples will be also collected every 60 min (in 500 ml sampling bag) for the measurement of breath acetone concentration using a novel gas analyzer based on infrared laser spectroscopy.
Measurements will be done during 3 consecutive periods:
- 0-120 min: Fast + Rest: subjects will remain lying in bed in fasting conditions (negative energy balance).
- 120-360 min: Fed + Rest: subjects will remain in bed in a fasting state (C) or will receive every hour a liquid meal containing either 70% fat, 15% carbohydrate and 15% protein (Fat), or 70% carbohydrate, 15% fat and 15% protein (Sugar), corresponding to 1.5 X hourly resting energy requirement (positive energy balance).
- 360-480 min: Fed + Exercise: subjects will be transferred to an ergometric bicycle and will be asked to bike at a power output of 25 W [i.e. increasing total energy expenditure to ca. 2 time resting energy expenditure (negative energy balance)].
- Being tested
- Fasting condition, Sugar condition, Fat condition
- Keywords
- breath acetone, energy balance
- Medical subject headings
- Fasting, Lecithin Cholesterol Acyltransferase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting conditionOther
Subjects will fast over the whole experimental period (480 min)
Sugar conditionOther
After a 2-h fasting state, subjects will ingest every hour a drink containing 70% carbohydrate, 15% fat and 15% protein and providing 1.5 X hourly resting energy requirement.
Fat conditionOther
After a 2-h fasting state, subjects will ingest every hour a drink containing 70% fat, 15% carbohydrate and 15% protein and providing 1.5 X hourly resting energy requirement.
| Study group | Role | What they receive |
|---|---|---|
| Fasting condition | Experimental | Effects of cumulated negative energy balance (fasting over 480 min) on breath acetone changes Receives: Other: Fasting condition |
| Sugar condition | Active comparator | Effects of sugar consumption on breath acetone changes Receives: Other: Sugar condition |
| Fat condition | Active comparator | Effects of fat consumption on breath acetone changes Receives: Other: Fat condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath acetone
Changes in breath acetone concentrations in conditions of positive vs. negative energy balance.
Measured: Every 60 min from 0 to 420 min
Secondary outcomes (1)
Plasma parameters
Relationship between breath acetone and plasma beta-hydroxybutyrate, glucose, free fatty acids and insulin concentrations
Measured: Every 60 min from 0 to 420 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study startNov 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FastingStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Collaborators
- Empa - Swiss Federal Laboratories for Materials Testing and Research, Zürich
- Responsible party
- Principal investigator, Luc Tappy, MD, University of Lausanne
- Investigators
- Luc Tappy, MD, Principal investigator, Department of Physiology, University of Lausanne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390881
- Sponsor's protocol ID
- 2016-01740
- Other IDs
- 2016
- Acronym
- ACEX
- Status last verified
- Dec 2017
- First submitted
- 28 Dec 2017
- Last updated
- 4 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Validity of Breath Acetone Concentration as a Bio-marker of Instantaneous Energy Balance in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03390881
- Acronym / sponsor ID
- ACEX / 2016-01740
- Keywords
- breath acetone, energy balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Collaborators
- Empa - Swiss Federal Laboratories for Materials Testing and Research, Zürich
- Study start
- Nov 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 4 Jan 2018 (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 study aims at assessing whether breath acetone concentration is a good bio-marker of instantaneous energy balance in healthy subjects.
Detailed description
Each participant will be studied on three occasions, separated by 1-4 weeks. Each evaluation will consist in the same set of metabolic measurements, but will be performed fasting or during administration of a 70% fat or 70% carbohydrate liquid diet, according to a randomized order.
On each occasion, subjects will consume a standardized dinner the day before the experiment. They will remain fasted since 10 pm until the test day.
On the day of the experiments, one venous cannula will be inserted into a forearm vein for the collection of blood samples. An indirect calorimetry (measurement of respiratory gas exchanges using a ventilated canopy at rest, or a face mask during exercise) will be performed throughout the 6-hour test to measure energy expenditure and net substrate oxidation rate. Blood samples will be obtained every 60 min for the measurement of plasma glucose, insulin, free fatty acids, and beta-hydroxybutyrate concentrations. Breath samples will be also collected every 60 min (in 500 ml sampling bag) for the measurement of breath acetone concentration using a novel gas analyzer based on infrared laser spectroscopy.
Measurements will be done during 3 consecutive periods:
- 0-120 min: Fast + Rest: subjects will remain lying in bed in fasting conditions (negative energy balance).
- 120-360 min: Fed + Rest: subjects will remain in bed in a fasting state (C) or will receive every hour a liquid meal containing either 70% fat, 15% carbohydrate and 15% protein (Fat), or 70% carbohydrate, 15% fat and 15% protein (Sugar), corresponding to 1.5 X hourly resting energy requirement (positive energy balance).
- 360-480 min: Fed + Exercise: subjects will be transferred to an ergometric bicycle and will be asked to bike at a power output of 25 W [i.e. increasing total energy expenditure to ca. 2 time resting energy expenditure (negative energy balance)].
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fasting condition | Experimental | Other: Fasting conditionEffects of cumulated negative energy balance (fasting over 480 min) on breath acetone changes |
| Sugar condition | Active comparator | Other: Sugar conditionEffects of sugar consumption on breath acetone changes |
| Fat condition | Active comparator | Other: Fat conditionEffects of fat consumption on breath acetone changes |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI 19.5-29.9 kg/m2,
- Healthy
Key exclusion criteria (5 listed)
- any known disease (with the exception of allergies);
- consumption of alcohol > 40 g/day;
- any current drug treatment (with the exception of contraceptive agents, antihistaminergic drugs for allergies, or multivitamin supplementations),
- history of lactose intolerance,
- history of exercise intolerance.
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 |
|---|---|---|
| Fasting conditionSubjects will fast over the whole experimental period (480 min) | Other | Fasting condition |
| Sugar conditionAfter a 2-h fasting state, subjects will ingest every hour a drink containing 70% carbohydrate, 15% fat and 15% protein and providing 1.5 X hourly resting energy requirement. | Other | Sugar condition |
| Fat conditionAfter a 2-h fasting state, subjects will ingest every hour a drink containing 70% fat, 15% carbohydrate and 15% protein and providing 1.5 X hourly resting energy requirement. | Other | Fat condition |
Primary outcome
Breath acetone
Time frame: Every 60 min from 0 to 420 min
Changes in breath acetone concentrations in conditions of positive vs. negative energy balance.
1 secondary outcome
Plasma parameters
Time frame: Every 60 min from 0 to 420 min
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 Jan 2018.
- Individual participant dataSharing planned: No
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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.
Luc Tappy, MD principal investigator
Department of Physiology, University of Lausanne, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting condition, Sugar condition and Fat condition in people with Fasting and Fed, run by University of Lausanne 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 2 inclusion and 5 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 Jan 2018. 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?
Breath acetone (time frame: Every 60 min from 0 to 420 min). 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 Jan 2018.