Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02385565
Recruitment Status : Completed
First Posted : March 11, 2015
Last Update Posted : March 11, 2015
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Mitochondrial Cytopathies Disorders Other: high fat diet Other: normal fat diet Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect Of The System In The Enriched Fat Metabolism Of The Child Reached Mitochondrial Cytopathy
Study Start Date : February 2004
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2009

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

Primary Outcome Measures :
  1. resting energy expenditure [ Time Frame: up to 3 months ]
    resting energy expenditure measured by indirect calorimetry

Secondary Outcome Measures :
  1. diet induced thermogenesis [ Time Frame: baseline, 1 month, 2 months, 3 months ]
    diet induced thermogenesis measured by indirect calorimetry

  2. body composition [ Time Frame: baseline, 1 month, 2 months, 3 months ]
    body composition by DEXA

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   5 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02385565

Layout table for location information
Centre d'Investigation Clinique
Lille, France, 59037
Centre d'Investigation Clinique
Paris, France, 75000
Sponsors and Collaborators
University Hospital, Lille
Ministry of Health, France
Layout table for investigator information
Principal Investigator: Dries DOBBELAERE, MD University Hospital, Lille

Layout table for additonal information
Responsible Party: University Hospital, Lille Identifier: NCT02385565    
Other Study ID Numbers: 2004/0401
2004/0138 ( Other Identifier: DGS )
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Kearns-Sayre Syndrome
Ophthalmoplegia, Chronic Progressive External
Mitochondrial Myopathies
Muscular Diseases
Musculoskeletal Diseases
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Eye Diseases
Retinitis Pigmentosa
Retinal Dystrophies
Retinal Degeneration
Retinal Diseases
Heart Diseases
Cardiovascular Diseases
Mitochondrial Diseases
Metabolic Diseases
Signs and Symptoms