NCT02644239

Brief Summary

The ketogenic diet is a non-pharmacological treatment prescribed especially for children and indicated in most specialized centers for patients with refractory epilepsy. The composition of the ketogenic diet is based on high-fat, low-carbohydrate, moderate protein content, and the production of ketone bodies is the probable mechanism involved in the control of seizures. The relationship between the treatment of the ketogenic diet and changes in oxidative characteristics, physical and lipid are not well established. Some studies show a significant increase in total cholesterol and triglycerides in children being treated with ketogenic diet, but other studies have shown that changes in lipid profile in the long term do not appear to be significant, beyond the influence of these changes on coronary heart disease are unknown. The studies performed in the last two decades have shown that besides the changes in the lipid profile, oxidative modification of lipoproteins are essential for the initiation and progression of atherosclerosis and physical properties of lipoproteins also appear to be involved in this process, suggesting that the particle size of lipoproteins, through the analysis of subfractions can provide more details of the cardiovascular risk. Thus, this projetct aims to compare the effects of the classical ketogenic diet with the ketogenic diet modified with lower content of saturated fatty acids and a higher content of monounsaturated and polyunsaturated, the oxidative changes of LDL, lipidomic profile, the concentration of antioxidants in production inflammatory cytokines and the subfractions of LDL and HDL in children and adolescents with refractory epilepsy, the clinical effect on controlling epilepsy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2012

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 31, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

December 31, 2015

Status Verified

December 1, 2015

Enrollment Period

8.1 years

First QC Date

October 13, 2015

Last Update Submit

December 28, 2015

Conditions

EpilepsyCardiovascular DiseaseNon-alcoholic Fatty Liver DiseaseQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Socioeconomic and clinical profile

    age, income, disease, parent´s education, use of drugs and supplements, type of seizures, questions about quality of life

    average of 3 months

Secondary Outcomes (4)

  • Body Mass Index

    average of 3 months

  • Fat mass

    average of 3 months

  • Fat free mass

    average of 3 months

  • Phase angle

    average of 3 months

Other Outcomes (12)

  • Assessement of food intake

    average of 3 months

  • Ketone bodies

    average of 3 months

  • Lipid profile

    average of 3 months

  • +9 more other outcomes

Study Arms (2)

Group control

ACTIVE COMPARATOR

classical ketogenic diet

Dietary Supplement: ketogenic diet

Group case

ACTIVE COMPARATOR

Group case: modified ketogenic diet to reduce at least 20% saturated fat, up\> 50% of the acid supply monounsaturated, increasing\> 50% polyunsaturated fatty acid content and a lower ratio w6 / w3 at least 50% compared to classic diet used by the control group

Dietary Supplement: ketogenic diet

Interventions

ketogenic dietDIETARY_SUPPLEMENT

Ketogenic diet with high fat (90%)

Group caseGroup control

Eligibility Criteria

Age1 Year - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may not qualify if:

  • Children and adolescents who submit diagnosis of diabetes mellitus and hypothyroidism or hyperthyroidism ;
  • Children and adolescents showing acute disorders as heart disease and kidney diseases .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nagila Raquel Teixeira Damasceno

São Paulo, São Paulo, 01246-904, Brazil

RECRUITING

Related Publications (13)

  • Avogaro P, Bon GB, Cazzolato G. Presence of a modified low density lipoprotein in humans. Arteriosclerosis. 1988 Jan-Feb;8(1):79-87.

    PMID: 3341993BACKGROUND

  • Avogaro P, Cazzolato G, Bittolo-Bon G. Some questions concerning a small, more electronegative LDL circulating in human plasma. Atherosclerosis. 1991 Nov;91(1-2):163-71. doi: 10.1016/0021-9150(91)90198-c.

    PMID: 1811552BACKGROUND

  • Faulin Tdo E, de Sena-Evangelista KC, Pacheco DB, Augusto EM, Abdalla DS. Development of immunoassays for anti-electronegative LDL autoantibodies and immune complexes. Clin Chim Acta. 2012 Jan 18;413(1-2):291-7. doi: 10.1016/j.cca.2011.10.004. Epub 2011 Oct 18.

    PMID: 22037508BACKGROUND

  • Fisher RS, Acevedo C, Arzimanoglou A, Bogacz A, Cross JH, Elger CE, Engel J Jr, Forsgren L, French JA, Glynn M, Hesdorffer DC, Lee BI, Mathern GW, Moshe SL, Perucca E, Scheffer IE, Tomson T, Watanabe M, Wiebe S. ILAE official report: a practical clinical definition of epilepsy. Epilepsia. 2014 Apr;55(4):475-82. doi: 10.1111/epi.12550. Epub 2014 Apr 14.

    PMID: 24730690BACKGROUND

  • Fisher RS, van Emde Boas W, Blume W, Elger C, Genton P, Lee P, Engel J Jr. Epileptic seizures and epilepsy: definitions proposed by the International League Against Epilepsy (ILAE) and the International Bureau for Epilepsy (IBE). Epilepsia. 2005 Apr;46(4):470-2. doi: 10.1111/j.0013-9580.2005.66104.x.

    PMID: 15816939BACKGROUND

  • Freeman JM, Kossoff EH, Hartman AL. The ketogenic diet: one decade later. Pediatrics. 2007 Mar;119(3):535-43. doi: 10.1542/peds.2006-2447.

    PMID: 17332207BACKGROUND

  • Kossoff EH, Zupec-Kania BA, Amark PE, Ballaban-Gil KR, Christina Bergqvist AG, Blackford R, Buchhalter JR, Caraballo RH, Helen Cross J, Dahlin MG, Donner EJ, Klepper J, Jehle RS, Kim HD, Christiana Liu YM, Nation J, Nordli DR Jr, Pfeifer HH, Rho JM, Stafstrom CE, Thiele EA, Turner Z, Wirrell EC, Wheless JW, Veggiotti P, Vining EP; Charlie Foundation, Practice Committee of the Child Neurology Society; Practice Committee of the Child Neurology Society; International Ketogenic Diet Study Group. Optimal clinical management of children receiving the ketogenic diet: recommendations of the International Ketogenic Diet Study Group. Epilepsia. 2009 Feb;50(2):304-17. doi: 10.1111/j.1528-1167.2008.01765.x. Epub 2008 Sep 23.

    PMID: 18823325BACKGROUND

  • Kwiterovich PO Jr, Vining EP, Pyzik P, Skolasky R Jr, Freeman JM. Effect of a high-fat ketogenic diet on plasma levels of lipids, lipoproteins, and apolipoproteins in children. JAMA. 2003 Aug 20;290(7):912-20. doi: 10.1001/jama.290.7.912.

    PMID: 12928468BACKGROUND

  • Lee PR, Kossoff EH. Dietary treatments for epilepsy: management guidelines for the general practitioner. Epilepsy Behav. 2011 Jun;21(2):115-21. doi: 10.1016/j.yebeh.2011.03.008. Epub 2011 Apr 21.

    PMID: 21514240BACKGROUND

  • Libby P, Ridker PM, Hansson GK; Leducq Transatlantic Network on Atherothrombosis. Inflammation in atherosclerosis: from pathophysiology to practice. J Am Coll Cardiol. 2009 Dec 1;54(23):2129-38. doi: 10.1016/j.jacc.2009.09.009.

    PMID: 19942084BACKGROUND

  • Liu YM, Williams S, Basualdo-Hammond C, Stephens D, Curtis R. A prospective study: growth and nutritional status of children treated with the ketogenic diet. J Am Diet Assoc. 2003 Jun;103(6):707-12. doi: 10.1053/jada.2003.50136.

    PMID: 12778041BACKGROUND

  • WHO Multicentre Growth Reference Study Group. WHO Child Growth Standards based on length/height, weight and age. Acta Paediatr Suppl. 2006 Apr;450:76-85. doi: 10.1111/j.1651-2227.2006.tb02378.x.

    PMID: 16817681BACKGROUND

  • de Onis M, Onyango AW, Borghi E, Siyam A, Nishida C, Siekmann J. Development of a WHO growth reference for school-aged children and adolescents. Bull World Health Organ. 2007 Sep;85(9):660-7. doi: 10.2471/blt.07.043497.

    PMID: 18026621BACKGROUND

MeSH Terms

Conditions

EpilepsyCardiovascular DiseasesNon-alcoholic Fatty Liver Disease

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesFatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-RestrictedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Mariana Baldini Prudencio, Master

    Universidade of Sao Paulo

    STUDY CHAIR

Central Study Contacts

Nagila Raquel Teixeira Damasceno, Ph D

CONTACT

+55(11) 3061-7865nagila@usp.br

Patricia Azevedo, Ph D Student

CONTACT

1130617865patricia.azlima@yahoo.com.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. Student

Study Record Dates

First Submitted

October 13, 2015

First Posted

December 31, 2015

Study Start

June 1, 2012

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

December 31, 2015

Record last verified: 2015-12

Locations

BR(1)