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A study in Adults with Autosomal Dominant Polysystic Kidney Disease (ADPKD): Interventional study into the effect of a ketogenic dietary intervention and its effect on glucose metabolism

An interventional assessment of the metabolic effects of a low-carbohydrate/ketogenic diet combined with ketone supplementation in adults with Autosomal Dominant Polysystic Kidney Disease (ADPKD)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000785404
Enrollment
20
Registered
2025-07-25
Start date
2025-07-28
Completion date
2027-07-30
Last updated
2025-09-08

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

Conditions

None listed

Brief summary

This study aims to explore whether a low-carbohydrate/ketogenic diet combined with ketone supplementation can improve kidney and metabolic health in adults with Autosomal Dominant Polycystic Kidney Disease (ADPKD). The study will assess safety, feasibility, and changes in quality of life, kidney function, and metabolic markers. Participants will receive dietary support via a smartphone app, take a ketone supplement, and use continuous glucose monitoring. The hypothesis is that reducing glucose availability and supporting nutritional ketosis may slow disease progression and improve overall wellbeing in people with ADPKD.

Interventions

Participants will follow a low-carbohydrate/ketogenic dietary program designed to reduce glucose availability and promote nutritional ketosis. This dietary intervention will be supported by the Defeat Diabetes App, which provides structured meal plans, educational content, and behavioural support to facilitate adherence. Prior to commencing the dietary intervention and exogenous ketone supplementation, participants will attend an initial consultation session with a member of the research team.

Participants will follow a low-carbohydrate/ketogenic dietary program designed to reduce glucose availability and promote nutritional ketosis. This dietary intervention will be supported by the Defeat Diabetes App, which provides structured meal plans, educational content, and behavioural support to facilitate adherence. Prior to commencing the dietary intervention and exogenous ketone supplementation, participants will attend an initial consultation session with a member of the research team. This session will last approximately 30 minutes and will include an introduction to the dietary program, guidance on using the Defeat Diabetes App, and an opportunity for participants to ask questions and clarify any concerns. During this session, participants will also be introduced to continuous glucose monitoring (CGM) devices to track real-time glucose levels throughout the intervention. The CGM system includes an associated mobile app that allows participants to view their glucose data, identify trends, and receive alerts. This data will support dietary behaviour change by helping participants understand the impact of food choices on glucose levels. In addition to dietary changes, participants will receive exogenous ketone supplementation using KetoCitra®, a medical food formulation designed for individuals with polycystic kidney disease. The supplement will be administered orally, at a dose of one scoop (approximately 10g) twice daily, mixed with water, for the duration of the 12-week intervention period. Participants will also use continuous glucose monitoring (CGM) devices to track real-time glucose levels and support dietary behaviour change. CGM data will be reviewed by the research team and used to provide personalised feedback via the app.

Sponsors

The Royal Melbourne Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adult patients with a diagnosis of ADPKD Adult patients providing informed consent

Exclusion criteria

Inabilitly to provide informed consent Pregnancy or breastfeeding

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026