Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000785404
Ethics application status
Approved
Date submitted
4/07/2025
Date registered
25/07/2025
Date last updated
25/07/2025
Date data sharing statement initially provided
25/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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)
Secondary ID [1] 314730 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autosomal Dominant Polycisitic Kidney Disease (ADPKD) 337933 0
Condition category
Condition code
Renal and Urogenital 334255 334255 0 0
Kidney disease
Human Genetics and Inherited Disorders 334256 334256 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 331332 0
Treatment: Drugs
Intervention code [2] 331500 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341921 0
Tolerability of the ketogenic dietary intervention
Timepoint [1] 341921 0
At 3 months post-intervention
Primary outcome [2] 342020 0
Change in quality of life
Timepoint [2] 342020 0
Baseline and at 3 months post-intervention
Primary outcome [3] 342021 0
Change in kidney function
Timepoint [3] 342021 0
Baseline and at 3 months post-intervention
Secondary outcome [1] 449015 0
Change in fasting blood glucose
Timepoint [1] 449015 0
Baseline and 3 months post-intervention
Secondary outcome [2] 449335 0
Change in insulin resistance
Timepoint [2] 449335 0
Baseline and at 3 months post-intervention
Secondary outcome [3] 449336 0
Change in liver function
Timepoint [3] 449336 0
Baseline and 3 months post-intervention
Secondary outcome [4] 449337 0
Change in uric acid levels
Timepoint [4] 449337 0
Baseline and at 3 months post-intervention
Secondary outcome [5] 449338 0
Change in lipid profile
Timepoint [5] 449338 0
Baseline and at 3 months post-intervention
Secondary outcome [6] 449339 0
Change in HbA1c
Timepoint [6] 449339 0
Baseline and at 3 months post-intervention
Secondary outcome [7] 449340 0
Change in proteinuria
Timepoint [7] 449340 0
Baseline and at 3 months post-intervention
Secondary outcome [8] 449341 0
Change in glucose variability
Timepoint [8] 449341 0
During the first month of intervention and the third month of interventions (two 14-day CGM cycles)
Secondary outcome [9] 449342 0
Adverse events
Timepoint [9] 449342 0
Ongoing throughout the 3-month study period
Secondary outcome [10] 450012 0
Change in kidney function
Timepoint [10] 450012 0
Baseline and at 3 months post-intervention

Eligibility
Key inclusion criteria
Adult patients with a diagnosis of ADPKD
Adult patients providing informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inabilitly to provide informed consent
Pregnancy or breastfeeding

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Analysis of this exploratory study will be primarily descriptive. Formal hypothesis testing will only be undertaken in comparing changes in participant results before and after the intervention.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/07/2025
Actual
Date of last participant enrolment
Anticipated
30/07/2027
Actual
Date of last data collection
Anticipated
29/10/2027
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 28146 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 44352 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 319282 0
Hospital
Name [1] 319282 0
The Royal Melbourne Hospital
Country [1] 319282 0
Australia
Primary sponsor type
Hospital
Name
The Royal Melbourne Hospital
Address
Country
Australia
Secondary sponsor category [1] 321756 0
None
Name [1] 321756 0
Address [1] 321756 0
Country [1] 321756 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317859 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 317859 0
Ethics committee country [1] 317859 0
Australia
Date submitted for ethics approval [1] 317859 0
Approval date [1] 317859 0
27/02/2025
Ethics approval number [1] 317859 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142382 0
Prof Karen Dwyer
Address 142382 0
Royal Melbourne Hospital, 300 Grattan St, Parkville VIC 3050
Country 142382 0
Australia
Phone 142382 0
+61 3 93428361
Fax 142382 0
Email 142382 0
[email protected]
Contact person for public queries
Name 142383 0
Karen Dwyer
Address 142383 0
Royal Melbourne Hospital, 300 Grattan St, Parkville VIC 3050
Country 142383 0
Australia
Phone 142383 0
+61 3 93427143
Fax 142383 0
Email 142383 0
[email protected]
Contact person for scientific queries
Name 142384 0
Karen Dwyer
Address 142384 0
Royal Melbourne Hospital, 300 Grattan St, Parkville VIC 3050
Country 142384 0
Australia
Phone 142384 0
+61 3 93427143
Fax 142384 0
Email 142384 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.