Pilot Study of the Modified Atkins Diet for Tourette Syndrome

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00952601
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 21.9
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated 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: Sep 1, 2008
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Tic frequency [2 months]

   Number of tics per day, intensity, severity, will be compared to baseline (pre-diet)

Secondary Outcome Measures

1. Ketosis [2 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 65 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

• Johns Hopkins University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Kossoff EH, Dorward JL. The modified Atkins diet. Epilepsia. 2008 Nov;49 Suppl 8:37-41. doi: 10.1111/j.1528-1167.2008.01831.x. Review.

• ClinicalTrials.gov Identifier: NCT00952601
• Other Study ID Numbers: AtkinsTourette
• First Posted: Aug 6, 2009
• Last Update Posted: Jul 15, 2010
• Last Verified: Jul 1, 2010

• Keywords provided by , ,: Tourette; Atkins; Ketosis; Tic
• Additional relevant MeSH terms: Tourette Syndrome; Syndrome

Study Results

No Results Posted as of Jul 15, 2010