Efficacy, Tolerability and Adherence of the Modified Atkins Diet on Drug-resistant Epilepsy

June 8, 2017 updated by: María Ingrid Alanis Guevara, Instituto Mexicano del Seguro Social

Efficacy, Tolerability and Adherence of the Modified Atkins Diet on Drug-resistant Epilepsy in Adults Patients

The Atkins Diet Modified (ADM) is the best alternative treatment for drug-resistant epilepsy, There is a high prevalence worldwide , especially in Latin American countries, including Mexico.

Low income earners, many of which do not have a social security, must meet the high costs by Antiepileptic Drugs (AEDS), which in addition should be used in conjunction or combination therapy, because monotherapy is insufficient .

The diet adkins makes some changes in the traditional food habits by others that are accessible and not necessarily expensive, whose mechanism allows for better control of the seizures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective: To assess the efficacy, tolerability and adherence of the modified adkins diet in adult patients with drug-resistent epilepsy Materials and Methods: Clinical trial, made up of patients with drug-resistent epilepsy, selected by convenience, who will be handled pharmacologically with the standard treatment of this condition for a period of not less than 6 months, after which they will be treated with adkins diet modified, prior informed consent, to establish its effect and a comparative analysis later.

The objective of this work is to analyze the efficacy, tolerability and adherence of the modified atkins diet in adult patients with drug-resistant epilepsy.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • Western Medical Center, Mexican Institute of Social Security

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Minimum age of 18 years
  • Patients that meet the criteria of drug-resistant epilepsy
  • Patients treated with Rational polytherapy, a minimum of 6 months, with no changes in their drug refractory condition.
  • Patients with drug- resistant epilepsy with informed consent signed by themselves and their proxy.
  • Patients with drug-resistant epilepsy of any etiology, except tumor, metabolic, degenerative or progressive.

Exclusion Criteria:

  • Patients with drug-resistant epilepsy simultaneous alternate treatment to the Atkins Diet modified.
  • Patients with a neurological entity progressive and fatal
  • Patients with congenital diseases and difficulty to metabolize fats or that require high amounts of carbohydrates in the diet.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: modified adkins diet
modified adkins diet. It consists in the free intake of proteins and fats, and the restriction of carbohydrates that are gradually being installed. Its mechanism of action that induces a state of ketosis.
Other: modified adkins diet
Patients were assigned to two groups, one of them received modified adkins diet for treatment of drug-resistant epilepsy. It consists in the free intake of proteins and fats, and the restriction of carbohydrates that are gradually being installed. Its mechanism of action that induces a state of ketosis
Other Names:
  • adkins diet in drug-resistant epilepsy
ACTIVE_COMPARATOR: Pharmacotherapy without diet
It consists in administer only pharmacological treatment withot a special diet, Drug-resistant epilepsy is characterized by the use of antiepileptic drugs and in optimal doses, depending on the type of epilepsy, at least on two consecutive occasions without response to management.
Drug: Pharmacotherapy without diet
Patients were assigned to two groups, one of them received conventional treatment with antiepileptic drugs without a special diet
Other Names:
  • treatment with antiepileptic drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of epileptic seizures
Time Frame: 3 months
Frequency of epileptic seizures measured according to the clinical criteria of therapeutic evaluation of Huttenlocher
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Therapeutic response observed in electroencephalogram
Time Frame: 3 months
Panic electroencephalographic criteria on the therapeutic response. Having regard to the standardization, improvement or worsening of the crisis in the electroencephalogram
3 months
Measurement of quality of life and decrease in seizures
Time Frame: 3 months
Interrogate the patient with a questionnaire of refractory epilepsy drugs. And ask to the patient with this questionnaire if improved their quality of life and have decreased seizures after using the atkins diet modified.
3 months
Blood tests (Hematic biometry)
Time Frame: 3 months
Take this blood test to assess the general conditions of the patient and see their levels of hemoglobin, hematocrit, leukocyte and platelet count.
3 months
Blood chemistry (serum electrolytes)
Time Frame: 3 months
It will evaluate the general condition of the patient and with this test rule out the presence of electrolyte imbalance
3 months
liver function tests
Time Frame: 3 months
Will be evaluated with this test levels of transaminases as can be raised by treatment anticonvulsant and see if there are any changes with the changes in the diet of patients
3 months
ketonuria
Time Frame: 3 months
It will assess the levels of ketones in urine due to the change in the diet of patients with the Atkins diet
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Mexicano del Seguro Social

Investigators

  • Principal Investigator: María I Alanis, Instituto Mexicano del Seguro Social

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2015

Primary Completion (ACTUAL)

April 30, 2016

Study Completion (ACTUAL)

December 30, 2016

Study Registration Dates

First Submitted

May 31, 2017

First Submitted That Met QC Criteria

June 8, 2017

First Posted (ACTUAL)

June 9, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 9, 2017

Last Update Submitted That Met QC Criteria

June 8, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F2016-1301-72

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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