Effectiveness of ketogenic diet on excessive daytime sleepiness in adults with narcolepsy type 1: a proof of concept study

Effectiveness of ketogenic diet on excessive daytime sleepiness in adults with narcolepsy type 1: a proof of concept study - Effectiveness of ketogenic diet in narcolepsy type 1

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51890

Enrollment

Registered

2021-08-12

Start date

2022-02-14

Completion date

Unknown

Last updated

2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

low-carbohydrate high-fat

Interventions

All participants follow a ketogenic diet as instructed and monitored by a certified dietician for 12 weeks. Then participants are asked to continue the diet without guidance by a dietician. Outcomes

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Diagnosis of narcolepsy type 1 as classified by the International Classification of Sleep Disorders-3 (ICSD-3) 18 years or older Motivated to commit to the diet

Exclusion criteria

Exclusion criteria: Underweight (BMI

Design outcomes

Primary

Measure	Time frame
Primary endpoint of the study is sleep latency on the Maintenance of Wakefulness Test (MWT).	—

Secondary

Measure	Time frame
Secondary parameters are sustained attention using the Sustained Attention to Response Task (SART), the self-reported EDS. mental wellbeing, sleep quality, ADHD symptoms, cataplexy, and feasibility of the ketogenic diet.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)