CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 10 enrolled
Drug / intervention
Modified Atkins dietdietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04722315
NCT04722315Early Ph 1Completed

Pilot Clinical Trial of Modified Atkins Diet for Kabuki Syndrome

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.·interventional·Posted Jan 25, 2021·Updated May 13, 2025

In Brief

A Early Phase 1 clinical trial evaluating Modified Atkins diet for Kabuki Syndrome. Completed, enrolled 10 participants across 1 site.

Detailed Summary

Animal models of Kabuki syndrome have showed a reversal of the cognitive phenotype with ketogenic diet. Modified Atkins diet is safer and easier tolerated than full ketogenic diet and still has the histone deacetylase inhibition believed to be responsible for the cognitive improvement. This study aims to examine a small number of adults with Kabuki syndrome before and after 12 weeks on a modified Atkins diet to determine if there is any cognitive improvement and if the diet can be tolerated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKabuki Syndrome
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
202120222023202420252026
First PostedJan 25, 2021
Enrollment StartApr 1, 2021
Primary CompletionJan 26, 2024
Study CompletionMar 12, 2025
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 5.4 years ago

Interventions

Modified Atkins dietdietary

12 weeks of modified Atkins diet