Pilot Study of the Modified Atkins Diet for Tourette Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00952601
Recruitment Status : Terminated (Insufficient interest and recruitment - study ended prematurely by investigators)
First Posted : August 6, 2009
Last Update Posted : July 15, 2010
Information provided by:
Johns Hopkins University

Brief Summary:
Pharmacotherapy has long been considered the primary approach for tic suppression in Tourette syndrome (TS). Unfortunately, medications are often ineffective and frequently have significant side-effects. This is a pilot therapeutic study using a dietary approach, the modified Atkins diet (MAD). The goal of this study is to establish the safety, tolerability, and efficacy of dietary therapy in patients with TS ("proof of concept") and to determine whether this intervention is worthy of evaluation in large-scale clinical trials. The modified Atkins diet mimics the well established ketogenic diet, but in a less-restrictive dietary manner. Dietary approaches using the MAD/ketogenic diet are currently under investigation for neurological conditions other than epilepsy, including Alzheimer disease, headaches, autism, narcolepsy, brain tumors, traumatic brain injury, Parkinson's disease, and depression.

Condition or disease Intervention/treatment Phase
Tourette Syndrome Dietary Supplement: Modified Atkins diet Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of the Modified Atkins Diet for Tourette Syndrome
Study Start Date : September 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Modified Atkins Diet
Patients are started on the modified Atkins diet at 15 grams per day.
Dietary Supplement: Modified Atkins diet
Low carbohydrate diet

Primary Outcome Measures :
  1. Tic frequency [ Time Frame: 2 months ]
    Number of tics per day, intensity, severity, will be compared to baseline (pre-diet)

Secondary Outcome Measures :
  1. Ketosis [ Time Frame: 2 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ages 12-65 years
  • Tourette syndrome (vocal and motor tics for over a year)
  • > 20 score on the Yale Global Tic Severity Scale
  • Ability to follow instructions and comply with the dietary changes

Exclusion Criteria:

  • Secondary tics
  • Underweight (BMI < 5%)
  • Prior use of the Atkins diet for over 2 days
  • High cholesterol or triglycerides
  • Major depression or anxiety disorder
  • Pregnancy
  • Substance abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00952601

United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University

Responsible Party: Eric Kossoff MD, Johns Hopkins University Identifier: NCT00952601     History of Changes
Other Study ID Numbers: AtkinsTourette
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: July 15, 2010
Last Verified: July 2010

Keywords provided by Johns Hopkins University:

Additional relevant MeSH terms:
Tourette Syndrome
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tic Disorders
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders