Abstract | BACKGROUND: METHODS/DESIGN: This is a 16-week, randomized, double-blind, placebo-controlled, crossover study to assess the safety and tolerability of a nutritional formula containing exogenous ketones. It also examines the potential for exogenous ketones to improve the patient's nutritional status which can impact the physiologic, symptomatic, and health outcome liabilities of living with Angelman syndrome. DISCUSSION: This manuscript outlines the rationale for a study designed to be the first to provide data on nutritional approaches for patients with Angelman syndrome using exogenous ketones. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03644693. Registered on 23 August 2018. Last updated on 23 August 2018.
|
Authors | Donna L Herber, Edwin J Weeber, Dominic P D'Agostino, Jessica Duis |
Journal | Trials
(Trials)
Vol. 21
Issue 1
Pg. 60
(Jan 09 2020)
ISSN: 1745-6215 [Electronic] England |
PMID | 31918761
(Publication Type: Clinical Trial Protocol, Journal Article)
|
Chemical References |
- Ketones
- 3-Hydroxybutyric Acid
|
Topics |
- 3-Hydroxybutyric Acid
(administration & dosage)
- Angelman Syndrome
(diet therapy, metabolism)
- Cross-Over Studies
- Diet, Carbohydrate-Restricted
- Diet, Ketogenic
- Double-Blind Method
- Glycemic Index
- Humans
- Ketones
(administration & dosage)
- Nutritional Status
- Randomized Controlled Trials as Topic
|