Mitochondrial Cytopathies DisordersMITOXNCT02385565
Effect Of The System In The Enriched Fat Metabolism Of The Child Reached Mitochondrial Cytopathy
A study testing high fat diet and normal fat diet in people with Mitochondrial Cytopathies Disorders, run by University Hospital, Lille at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 21 years
- Conditions the study is for
- Mitochondrial Cytopathies Disorders
- What is being tested?
- high fat diet and normal fat diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2004to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre d'Investigation Clinique
Lille, 59037
Centre d'Investigation Clinique
Paris, 75000
About this study
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.
Read the 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.
- Conditions
- Mitochondrial Cytopathies Disorders
- Being tested
- high fat diet, normal fat diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high fat dietOther
high fat diet as 10 % proteins, 30 % lipids, 60 % carbohydrates
normal fat dietOther
high fat diet as 10 % proteins, 45 % lipids,45 % carbohydrates
| Study group | Role | What they receive |
|---|---|---|
| high fat diet | Experimental | 10 % proteins, 30 % lipids, 60 % carbohydrates Receives: Other: high fat diet |
| Normal fat diet | Placebo comparator | 10 % proteins, 45 % lipids, 45 % carbohydrates Receives: Other: normal fat diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
resting energy expenditure
resting energy expenditure measured by indirect calorimetry
Measured: up to 3 months
Secondary outcomes (2)
diet induced thermogenesis
diet induced thermogenesis measured by indirect calorimetry
Measured: baseline, 1 month, 2 months, 3 months
body composition
body composition by DEXA
Measured: baseline, 1 month, 2 months, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startFeb 2004
- Primary completionDec 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mitochondrial Cytopathies DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Dries DOBBELAERE, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385565
- Sponsor's protocol ID
- 2004/0401
- Other IDs
- 2004/0138
- Acronym
- MITOX
- Status last verified
- Mar 2015
- First submitted
- 2 Mar 2015
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Beghin L, Coopman S, Schiff M, Vamecq J, Mention-Mulliez K, Hankard R, Cuisset JM, Ogier H, Gottrand F, Dobbelaere D. Doubling diet fat on sugar ratio in children with mitochondrial OXPHOS disorders: Effects of a randomized trial on resting energy expenditure, diet induced thermogenesis and body composition. Clin Nutr. 2016 Dec;35(6):1414-1422. doi: 10.1016/j.clnu.2016.03.015. Epub 2016 Apr 8.
PubMed 27173380
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of The System In The Enriched Fat Metabolism Of The Child Reached Mitochondrial Cytopathy
- ClinicalTrials.gov ID
- NCT02385565
- Acronym / sponsor ID
- MITOX / 2004/0401
- Conditions
- Mitochondrial Cytopathies Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Feb 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 11 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high fat diet | Experimental | Other: high fat diet10 % proteins, 30 % lipids, 60 % carbohydrates |
| Normal fat diet | Placebo comparator | Other: normal fat diet10 % proteins, 45 % lipids, 45 % carbohydrates |
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 5 to 21 years-old children,
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high fat diethigh fat diet as 10 % proteins, 30 % lipids, 60 % carbohydrates | Other | high fat diet |
| normal fat diethigh fat diet as 10 % proteins, 45 % lipids,45 % carbohydrates | Other | Normal fat diet |
Primary outcome
resting energy expenditure
Time frame: up to 3 months
resting energy expenditure measured by indirect calorimetry
2 secondary outcomes
diet induced thermogenesis
Time frame: baseline, 1 month, 2 months, 3 months
body composition
Time frame: baseline, 1 month, 2 months, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Results publication: PubMed 27173380Beghin L, Coopman S, Schiff M, Vamecq J, Mention-Mulliez K, Hankard R, Cuisset JM, Ogier H, Gottrand F, Dobbelaere D. Doubling diet fat on sugar ratio in children with mitochondrial OXPHOS disorders: Effects of a randomized trial on resting energy expenditure, diet induced thermogenesis and body composition. Clin Nutr. 2016 Dec;35(6):1414-1422. doi: 10.1016/j.clnu.2016.03.015. Epub 2016 Apr 8.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dries DOBBELAERE, MD principal investigator
University Hospital, Lille
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high fat diet and normal fat diet in people with Mitochondrial Cytopathies Disorders, run by University Hospital, Lille at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
resting energy expenditure (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02385565, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.