Effect Of The System In The Enriched Fat Metabolism Of The Child Reached Mitochondrial Cytopathy (MITOX)

April 17, 2026 updated by: University Hospital, Lille

The aim of the present study is to compare Resting Energy Expenditure (REE) between normal fat diet (NFD) as a control vs high fat diet (HFD) as a treatment in Mitochondrial cytopathies disorders ( MID's ) patients. Secondary objectives is to compare diet induced thermogenesis (DIT) and body composition between NFD vs HFD.

This study is a randomized cross-over study. Normal fat diet (ie 10 % proteins, 45 % lipids, 45 % carbohydrates) is the imposed diet at baseline, high fat diet (ie 10 % proteins, 30 % lipids, 60 % carbohydrates is used according to the cross-over design trial. Main evaluation criteria is REE and second evaluation criteria is DIT both measured by indirect calorimetry ). 36 included MID subjects will be included in this study. Main evaluation criteria and second evaluation criteria will be measured at baseline, 1 month, 2 month and 3 month.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

REE and DIT are measured by indirect calorimetry . The device used is a using an open-circuit ventilated hood system (QUARK RMR®, Cosmed, Pavona; Italy). The respiration quo- tient (RQ) and flow settings are calibrated by reference to alcohol combustion every six months. Before each test, the calorimeter is calibrated with a reference gas mixture (5% CO2, 95% O2 v/v). Expired carbon di- oxide (VCO2) and inspired oxygen (VO2) ¯flows are recorded, as well as the RQ. EE is calculated every minute from oxygen consumption (VO2 in ml/min) and carbon dioxide production (VCO2 in ml/min) using the Weir formula without protein correction. DIT is measured during 6 hours after a calibrated breakfast (normal fat diet or high fat diet according to the cross-over design) as 30% of theoric energy intake.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59037
        • Centre d'investigation Clinique
      • Paris, France, 75000
        • Centre d'investigation Clinique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 5 to 21 years-old children,

    • Children with a proven mitochondrial cytopathy documented on biopsies by histology, histoenzymology, ultrastructure and enzyme assay and/or on body fluids by laboratory markers including lactacidemia, metabolic acidosis, increased CSF lactate, lactate/pyruvate and beta-hydroxybutyrate/acetoacetate ratios, paradoxical postprandial ketonemia, alaninemia, citrullinemia, plasma acylcarnitines.
    • Children on the usual diet (30% lipids, 60% glucides and 10% proteins) for at least 1 month.
    • Informed consent of the 2 parents and from the child when in age to express a consent.
    • Child with a social security cover.

Exclusion Criteria:

  • Acute infection (fever > 38.5°C for more than 6h) within 7 days prior to the study.
  • Disability for understanding and following the protocol
  • Rejection of the study by the patient or failure to comply to the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: high fat diet
10 % proteins, 30 % lipids, 60 % carbohydrates
Other: high fat diet
high fat diet as 10 % proteins, 30 % lipids, 60 % carbohydrates
Placebo Comparator: Normal fat diet
10 % proteins, 45 % lipids, 45 % carbohydrates
Other: normal fat diet
high fat diet as 10 % proteins, 45 % lipids,45 % carbohydrates

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
resting energy expenditure
Time Frame: up to 3 months
resting energy expenditure measured by indirect calorimetry
up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diet induced thermogenesis
Time Frame: baseline, 1 month, 2 months, 3 months
diet induced thermogenesis measured by indirect calorimetry
baseline, 1 month, 2 months, 3 months
body composition
Time Frame: baseline, 1 month, 2 months, 3 months
body composition by DEXA
baseline, 1 month, 2 months, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Ministry of Health, France

Investigators

  • Principal Investigator: Dries DOBBELAERE, MD, University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

March 2, 2015

First Submitted That Met QC Criteria

March 10, 2015

First Posted (Estimated)

March 11, 2015

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004/0401
  • 2004/0138 (Other Identifier: DGS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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