Use of Breath Acetone aa a Marker of Energy Balance

NCT03390881 | Completed

• 1 other identifier: 2016-01740
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fasting; Fed

Keywords

breath acetone; energy balance

Outcome Measures

Primary Outcomes (1)

• Breath acetone

  Changes in breath acetone concentrations in conditions of positive vs. negative energy balance.

  Every 60 min from 0 to 420 min

Secondary Outcomes (1)

• Plasma parameters

  Every 60 min from 0 to 420 min

Study Arms (3)

Fasting condition

EXPERIMENTAL

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

Other: Fasting condition

Sugar condition

ACTIVE COMPARATOR

Effects of sugar consumption on breath acetone changes

Other: Sugar condition

Fat condition

ACTIVE COMPARATOR

Effects of fat consumption on breath acetone changes

Other: Fat condition

Interventions

Fasting condition OTHER

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

Fasting condition

Sugar condition 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.

Sugar condition

Fat condition 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.

Fat condition

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI 19.5-29.9 kg/m2,
• Healthy

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

University of Lausanne

Lausanne, 1005, Switzerland

Location

MeSH Terms

Conditions

Fasting; Lecithin Cholesterol Acyltransferase Deficiency

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Hypoalphalipoproteinemias; Hypolipoproteinemias; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Luc Tappy, MD

  Department of Physiology, University of Lausanne, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 4, 2018
• Study Start: November 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: January 4, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)