A Phase 1 interventional study of Modified Atkins diet in Tourette Syndrome, sponsored by Johns Hopkins University. Terminated at 1 site in United States. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-07-15.
Sponsored by Johns Hopkins University · Phase 1, Interventional, and Treatment
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.
220 studies on the registry are indexed under Tourette Syndrome; 37 are open to participants now.
This study's planned enrollment of 20 is below the median of 34 across 166 interventional studies indexed under Tourette Syndrome.
Browse Tourette Syndrome studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients are started on the modified Atkins diet at 15 grams per day.
Dietary Supplement: Modified Atkins diet
Low carbohydrate diet
Tic frequency
Number of tics per day, intensity, severity, will be compared to baseline (pre-diet)
Time frame: 2 months
Ketosis
Time frame: 2 months
This study is terminated, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.
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Johns Hopkins University