A Novel Approach to Manage Symptoms of Narcolepsy and Idiopathic Hypersomnia

NARecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

June 23, 2025

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Idiopathic HypersomniaNarcolepsy Type 1 (NT 1)Narcolepsy Type 2 (NT2)
Interventions
BEHAVIORAL

Whole Food Ketogenic Diet

Education around immediate changes to improve diet quality and barriers to dietary behaviour change. Participants will consume a whole-food diet focused on improving diet quality based on the NOVA classifications of unprocessed or minimally processed foods/ingredients (removal of NOVA category 4 foods from diet). This group will focus on the consumption of low-energy, nutrient dense whole foods with a targeted carbohydrate intake of 30-50g per day to achieve nutritional ketosis. The WFKD will adjust carbohydrate level for the individual participant to achieve average blood/urinary ketone levels of between 0.5 and 3.0 mmol/L (tested for objective feedback using a mix of urinary ketone sticks and finger prick blood measures).

BEHAVIORAL

Whole Food Diet

Education around immediate changes to improve diet quality and barriers to dietary behaviour change. Participants will consume a whole-food diet focused on improving diet quality based on the NOVA classifications of unprocessed or minimally processed foods/ingredients (removal of NOVA category 4 foods from diet). This diet is high carbohydrate (45-65% of total energy coming from carbohydrate, 20-35% from fat and 15-25% from protein) based on the Australian dietary guidelines focusing on the consumption of low-energy, nutrient dense whole foods. The higher carbohydrate diet reflects current contemporary 'standard care' dietary recommendations as outlined by the National Health and Medical Research Council's Australian Dietary Guidelines, and therefore represents the most appropriate control diet to compare to the effects of the proposed intervention.

Trial Locations (1)

2113

RECRUITING

Woolcock Institute of Medical Research, Macquarie Park

All Listed Sponsors
collaborator

Woolcock Institute of Medical Research

OTHER

lead

University of Sydney

OTHER

NCT07006233 - A Novel Approach to Manage Symptoms of Narcolepsy and Idiopathic Hypersomnia | Biotech Hunter | Biotech Hunter