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OpenTrials
Completed

NCT Number: NCT01834482

Modified Atkins Diet Plus KetoCal for Adult Epilepsy

The modified Atkins diet (MAD) has been shown to be effective in treating children and adults with medically resistant seizures. A recent study in children showed that the use of KetoCal® once per day in addition to the MAD appeared to be beneficial when used during the first month. The investigators hypothesize that including a daily KetoCal® liquid tetrapak with one meal during the initial month of the MAD will produce urinary ketosis in more adult patients than the MAD alone and will lead to greater seizure reduction.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Medically Resistant Epilepsy Medically Resistant Seizures Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizure Seizures Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults ages >17 years.
  • At least weekly seizures (or 4 per month). All seizure types allowed.
  • Tried at least two anticonvulsants.

Exclusion criteria

  • Unwilling to restrict carbohydrates
  • Significantly underweight (Body Mass Index <18.5)
  • Prior use of the modified Atkins diet for ≥ 2 days
  • Prior use of KetoCal® at any time for any duration
  • Use of the ketogenic diet within the past year
  • Kidney disease
  • History of hypercholesterolemia (total cholesterol > 300 mg/dl) or hypertriglyceridemia (triglycerides > 200 mg/dl)
  • Metabolic or mitochondrial disorder
  • Pregnancy or breastfeeding
  • Lactose intolerance or milk allergy
  • Aversion to liquids or inability to eat solid food

Treatment and study plan

Modified Atkins diet

Dietary Supplement

Patients will receive the modified Atkins diet with a 20 gram per day carbohydrate limit and encouragement to consume plenty of fat and eat to satiety.

KetoCal

Dietary Supplement

Patients will receive a KetoCal 4:1 ratio (fat: carbohydrates and protein) liquid daily for the first month (if randomized to this arm of the study). They will also be started on the modified Atkins diet.

Other names: KetoCal 4:1 liquid, KetoCal tetrapak

Primary outcomes

  1. Ketosis

    Time frame: 1 month

    Time to urinary ketosis in days will be recorded and whether or not patients achieve serum ketosis at 1 month and 2 months.

Secondary outcomes

  1. Seizure reduction

    Time frame: 2 months

    The percent seizure reduction compared to baseline (1 month before beginning the diet) will be recorded at 1 month and 2 months.

  2. Tolerability and taste

    Time frame: 2 months

    Patients will be asked to rank convenience, taste, texture, and tolerability of the liquid on a 10 point scale (1 = poor, 10 = excellent).

  3. Side effects

    Time frame: 2 months

    Patients will be screened for constipation and asked if they have experienced any side effects related to use of the modified Atkins diet and KetoCal® at 1 and 2 months.

  4. Study completion rate

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Nutricia Liverpool

Registry information

Official study title

A Randomized, Open-label Evaluation of KetoCal® in Initial Combination With the Modified Atkins Diet for the Dietary Management of Intractable Adult Epilepsy.

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Apr 18, 2013
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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