Pilot Study of the Modified Atkins Diet for Tourette Syndrome

Johns Hopkins University

Status and phase: Terminated; Phase 1

Conditions: Tourette Syndrome

Treatments: Dietary Supplement: Modified Atkins diet

Study type: Interventional

Funder types: Other

Identifiers

NCT00952601

AtkinsTourette

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Modified Atkins Diet

Experimental group

Description:

Patients are started on the modified Atkins diet at 15 grams per day.

Treatment:

Dietary Supplement: Modified Atkins diet