Pilot Study of the Modified Atkins Diet for Tourette Syndrome

Phase 1

Terminated

• Conditions: Tourette Syndrome
• Interventions: Dietary Supplement: Modified Atkins diet

• Registration Number: NCT00952601
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-08-03
• Study First Submitted QC: 2009-08-04
• Study First Posted: 2009-08-06
• Status Verified: 2010-07
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Last Update Submitted: 2010-07-14
• Last Update Posted: 2010-07-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Modified Atkins Diet	Modified Atkins diet	Patients are started on the modified Atkins diet at 15 grams per day.

Primary Outcome Measures

Name	Time	Method
Tic frequency	2 months	Number of tics per day, intensity, severity, will be compared to baseline (pre-diet)

Secondary Outcome Measures

Name	Time	Method
Ketosis	2 months

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States