An interventional study of high fat diet and normal fat diet in Mitochondrial Cytopathies Disorders, sponsored by University Hospital, Lille. Completed at 2 sites in France. Open to participants aged 5 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by University Hospital, Lille · Not applicable, Interventional, and Treatment
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.
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.
University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.
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5 to 21 years-old children,
Exclusion Criteria:
10 % proteins, 30 % lipids, 60 % carbohydrates
Other: high fat diet
10 % proteins, 45 % lipids, 45 % carbohydrates
Other: normal fat diet
high fat diet as 10 % proteins, 30 % lipids, 60 % carbohydrates
high fat diet as 10 % proteins, 45 % lipids,45 % carbohydrates
resting energy expenditure
resting energy expenditure measured by indirect calorimetry
Time frame: up to 3 months
diet induced thermogenesis
diet induced thermogenesis measured by indirect calorimetry
Time frame: baseline, 1 month, 2 months, 3 months
body composition
body composition by DEXA
Time frame: baseline, 1 month, 2 months, 3 months
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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University Hospital, Lille