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

Instituto Mexicano del Seguro Social

Status: Completed

Conditions: Epilepsy, Drug Resistant

Treatments: Drug: Pharmacotherapy without diet; Other: modified adkins diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03183076

F2016-1301-72

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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14 participants in 2 patient groups

modified adkins diet

Active Comparator group

Description:

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.

Treatment:

Other: modified adkins diet

Pharmacotherapy without diet

Active Comparator group

Description:

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.

Treatment:

Drug: Pharmacotherapy without diet