NCT02385565

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
Last Updated

April 22, 2026

Status Verified

March 1, 2015

Enrollment Period

4.8 years

First QC Date

March 2, 2015

Last Update Submit

April 17, 2026

Conditions

Mitochondrial Cytopathies Disorders

Outcome Measures

Primary Outcomes (1)

  • resting energy expenditure

    resting energy expenditure measured by indirect calorimetry

    up to 3 months

Secondary Outcomes (2)

  • diet induced thermogenesis

    baseline, 1 month, 2 months, 3 months

  • body composition

    baseline, 1 month, 2 months, 3 months

Study Arms (2)

high fat diet

EXPERIMENTAL

10 % proteins, 30 % lipids, 60 % carbohydrates

Other: high fat diet

Normal fat diet

PLACEBO COMPARATOR

10 % proteins, 45 % lipids, 45 % carbohydrates

Other: normal fat diet

Interventions

high fat dietOTHER

high fat diet as 10 % proteins, 30 % lipids, 60 % carbohydrates

high fat diet
normal fat dietOTHER

high fat diet as 10 % proteins, 45 % lipids,45 % carbohydrates

Normal fat diet

Eligibility Criteria

Age5 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre d'Investigation Clinique

Lille, 59037, France

Location

Centre d'Investigation Clinique

Paris, 75000, France

Location

Related Publications (1)

  • 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.

    PMID: 27173380RESULT

MeSH Terms

Interventions

Diet, High-Fat

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Dries DOBBELAERE, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2015

First Posted

March 11, 2015

Study Start

February 1, 2004

Primary Completion

December 1, 2008

Study Completion

December 1, 2009

Last Updated

April 22, 2026

Record last verified: 2015-03

Locations

FR(2)