Use of Breath Acetone aa a Marker of Energy Balance (ACEX)

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.

Study Overview

• Status: Completed
• Conditions: Fasting; Fed
• Intervention / Treatment: Other: Fasting condition; Other: Sugar condition; Other: Fat condition

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1005
    • University of Lausanne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Lausanne
• Collaborators: Empa - Swiss Federal Laboratories for Materials Testing and Research, Zürich

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: December 28, 2017
• First Submitted That Met QC Criteria: January 3, 2018
• First Posted (Actual): January 4, 2018

Study Record Updates

• Last Update Posted (Actual): January 4, 2018
• Last Update Submitted That Met QC Criteria: January 3, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: energy balance; breath acetone
• Other Study ID Numbers: 2016-01740

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No