Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy

NCT01311440 | Completed

• 1 other identifier: 2010/2326 (REK)
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

In Oslo University Hospital, department of complex epilepsy, offer ketogenic diet to treat children with medically intractable epilepsy. From 2009 we added modified Atkins diet as a treatment option for children up to 18 years. We now initiate an open, prospective, randomized and controlled study with the aim to test the efficacy of treatment with modified Atkins diet in adults with focal and generalized epilepsy diagnoses, in order to evaluate whether this treatment should be offered to patients on a permanent basis.

Conditions

Epilepsy; Focal Epilepsy; Generalized Epilepsy

Keywords

RCT; modified Atkins diet; epilepsy; adults; ketogenic diet

Outcome Measures

Primary Outcomes (1)

• Change in seizure frequency

  All participants record detailed seizure records for 12 weeks prior to the control/diet period. The diet group participants are subsequently treated with modified Atkins diet for 12 weeks, while the control group continue their normal diet and record seizures for another 12 weeks. Seizure records for each participant before and during intervention are compared.

  12 weeks

Secondary Outcomes (6)

• Change in body weight

  12 weeks

• Change in standard 3-hrs EEG

  12 weeks

• Change in life quality measured by validated questionnaire

  12 weeks

• Change in various blood and serum measures

  12 weeks

• Change in executive functions measured with validated questionnaire

  12 weeks

Study Arms (2)

Modified Atkins diet treatment

EXPERIMENTAL

12 weeks of Modified Atkins diet treatment, recording seizures

Other: Modified Atkins diet treatment

No intervention

NO INTERVENTION

12 weeks seizure record

Interventions

Modified Atkins diet treatment OTHER

Eat a diet containing 16 grams of carbohydrates per day, maximize on fat. Assure sufficient intake of micronutrients.

Modified Atkins diet treatment

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Focal or generalized epilepsy diagnosis
• More than 3 recordable seizures per month
• BMI \> 18,5
• Not responded to at least three 3 AEDs
• years or older
• Motivated to complete the diet after thorough information
• Capable of recording seizures
• Capable of preparing the diet

You may not qualify if:

• Hypercholesterolemia, cardiovascular disease or kidney disease
• Been on modified Atkins diet for more than one week during the last year
• Status epilepticus last six months
• epilepsy surgery or VNS implant last year
• weeks continuous seizure freedom last 2 months
• PNES seizures
• other disease where dietary treatment is contraindicated
• usage of drugs or supplements that may interfere with diet or AED
• being pregnant or planning pregnancy

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital, The national Centre for epilepsy

Sandvika, Bærum Postterminal, 1306, Norway

Location

MeSH Terms

Conditions

Epilepsy; Epilepsies, Partial; Epilepsy, Generalized

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Karl Otto Nakken

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Nutritionist

Study Record Dates

• First Submitted: March 7, 2011
• First Posted: March 9, 2011
• Study Start: March 1, 2011
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: September 19, 2017

Record last verified: 2017-09

Locations

NO (1)