Use of Breath Acetone aa a Marker of Energy Balance

NCT ID: NCT03390881

Last Updated: 2018-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-06-30

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)].

Conditions

Fasting; Fed

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Fasting condition

Effects of cumulated negative energy balance (fasting over 480 min) on breath acetone changes

Group Type: EXPERIMENTAL

Fasting condition

Intervention Type: OTHER

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

Sugar condition

Effects of sugar consumption on breath acetone changes

Group Type: ACTIVE_COMPARATOR

Sugar condition

Intervention Type: OTHER

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 condition

Effects of fat consumption on breath acetone changes

Group Type: ACTIVE_COMPARATOR

Fat condition

Intervention Type: OTHER

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.

Interventions

Fasting condition

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Empa - Swiss Federal Laboratories for Materials Testing and Research, Zürich

UNKNOWN

Sponsor Role: collaborator

University of Lausanne

OTHER

Sponsor Role: lead

Responsible Party

Luc Tappy, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luc Tappy, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Physiology, University of Lausanne, Switzerland

Locations

University of Lausanne

Lausanne, , Switzerland

Countries

Switzerland

Other Identifiers

2016-01740

Identifier Type: -

Identifier Source: org_study_id