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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2008

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.

Interventions

  • Other: high fat diet
    • high fat diet as 10 % proteins, 30 % lipids, 60 % carbohydrates
  • Other: normal fat diet
    • high fat diet as 10 % proteins, 45 % lipids,45 % carbohydrates

Arms, Groups and Cohorts

  • Experimental: high fat diet
    • 10 % proteins, 30 % lipids, 60 % carbohydrates
  • Placebo Comparator: Normal fat diet
    • 10 % proteins, 45 % lipids, 45 % carbohydrates

Clinical Trial Outcome Measures

Primary Measures

  • resting energy expenditure
    • Time Frame: up to 3 months
    • resting energy expenditure measured by indirect calorimetry

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: 21 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Lille
  • Collaborator
    • Ministry of Health, France
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dries DOBBELAERE, MD, Principal Investigator, University Hospital, Lille

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.