Use of Breath Acetone aa a Marker of Energy Balance

Study Overview
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Brief Summary
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This study aims at assessing whether breath acetone concentration is a good bio-marker of instantaneous energy balance in healthy subjects.

Detailed Description
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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)].

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

Conditions
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Fasting, Fed

Intervention / Treatment
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* Other: Fasting condition
* Other: Sugar condition
* Other: Fat condition


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fasting condition<br>Effects of cumulated negative energy balance (fasting over 480 min) on breath acetone changes | Other: Fasting condition<br>* Subjects will fast over the whole experimental period (480 min)<br>|
| Active Comparator: Sugar condition<br>Effects of sugar consumption on breath acetone changes | Other: Sugar condition<br>* 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.<br>|
| Active Comparator: Fat condition<br>Effects of fat consumption on breath acetone changes | Other: Fat condition<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breath acetone | Changes in breath acetone concentrations in conditions of positive vs. negative energy balance. | Every 60 min from 0 to 420 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma parameters | Relationship between breath acetone and plasma beta-hydroxybutyrate, glucose, free fatty acids and insulin concentrations | Every 60 min from 0 to 420 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breath acetone, energy balance