A Novel Approach to Manage Symptoms of Narcolepsy and Idiopathic Hypersomnia

Summary

The aim of this project is to learn about how a change in diet will affect sleepiness, quality of life and metabolic health in people living with narcolepsy and idiopathic hypersomnia. The dietary changes we will be testing are well researched and safe in a wide range of patient groups (such as in obesity, type one and two diabetes, cancer and dysfunction related to the nervous system) but has not been researched in conditions of hypersomnolence such as narcolepsy and idiopathic hypersomnia. It is important to test adjunct therapies and lifestyle changes such as dietary interventions to ensure that people living with hypersomnolence have a range of options in addition to medications, to improve their health.

If effective, this project will be tested in more people and may become a part of routine patient care. These dietary approaches have been shown to improve health and quality of life in people living with chronic pain, neurological conditions such as epilepsy and have been shown to be safe in these populations as well as people living with type one diabetes. This is a new area of research for people living with hypersomnolence.

Conditions

• Idiopathic Hypersomnia
• Narcolepsy 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.

Sponsors & Collaborators

• Woolcock Institute of Medical Research

  collaborator OTHER

• University of Sydney

  lead OTHER

Principal Investigators

• Elizabeth A Machan, PhD · University of Sydney

• Sheila Sivam, PhD; MD; FracP; BSc (Med) · Royal Prince Alfred Hospital and University of Sydney

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-23

Primary Completion

2026-06-30

Completion

2026-06-30

Countries

• Australia

Study Locations