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Use of Breath Acetone aa a Marker of Energy Balance

Assessment of the Validity of Breath Acetone Concentration as a Bio-marker of Instantaneous Energy Balance in Healthy Subjects

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03390881
Acronym
ACEX
Enrollment
8
Registered
2018-01-04
Start date
2016-11-30
Completion date
2017-06-30
Last updated
2018-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fasting, Fed

Keywords

breath acetone, energy balance

Brief summary

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 \[i.e. increasing total energy expenditure to ca. 2 time resting energy expenditure (negative energy balance)\].

Interventions

Subjects will fast over the whole experimental period (480 min)

OTHERSugar condition

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.

OTHERFat condition

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.

Sponsors

Empa - Swiss Federal Laboratories for Materials Testing and Research, Zürich
CollaboratorUNKNOWN
University of Lausanne
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* BMI 19.5-29.9 kg/m2, * Healthy

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Breath acetoneEvery 60 min from 0 to 420 minChanges in breath acetone concentrations in conditions of positive vs. negative energy balance.

Secondary

MeasureTime frameDescription
Plasma parametersEvery 60 min from 0 to 420 minRelationship between breath acetone and plasma beta-hydroxybutyrate, glucose, free fatty acids and insulin concentrations

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026