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Ketogenic Dietary Interventions in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

NCT04680780 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2022-08-24

No results posted yet for this study

Summary

A mild reduction in food intake significantly inhibits renal cyst growth in mouse models of ADPKD. The underlying mechanism was unknown at the time. Recently published data show that the beneficial effect is not due to caloric restriction per se but due to the induction of the state of ketosis. Dietary interventions leading to ketosis profoundly inhibited renal cyst growth in rodent models of PKD. In addition, acute fasting led to rapid regression of renal cystic burden in mouse, rat and feline models of PKD. Due to these compelling effects in a multitude of PKD animal models, and due to the fact that well-established dietary interventions have a tremendous translational potential, KETO-ADPKD will test such interventions regimens in ADPKD patients.

Two well-established ketogenic dietary regimens will be tested in comparison to a control group to address the following four questions:

1. Feasibility: Are ketogenic dietary interventions acceptable to ADPKD patients in everyday life?
2. Safety: Are there adverse events of ketogenic dietary interventions in ADPKD patients?
3. Efficacy: Do the dietary interventions reach the metabolic endpoints? Do they have a short-term impact on kidney volume?
4. Which of the two diets is the optimal approach?

These questions will be addressed in an exploratory, randomized, open, single center, three-arm dietary intervention study using the following interventions in 21 ADPKD patients per treatment arm:

A) Ketogenic diet B) 3-day water fasting C) Control: ad libitum food intake (no diet)

Conditions

  • ADPKD

Interventions

OTHER

Ketogenic diet

Patients will follow a classical ketogenic diet for 3 months

OTHER

3-days water-fasting

Patients will perform water fasting on 3 consecutive days within the first 14 days of each of the 3 months. In one of the 3 months they are - if required - allowed to split the 3 days into periods of 1 and 2 days. On all other days of the intervention period they are allowed to eat ad libitum.

OTHER

Control

Patients are allowed to eat ad libitum, but will be advised that low salt intake (\< 5-7 g/day) and sufficient fluid intake (\>3 l/day) which is considered beneficial in ADPKD.

Sponsors & Collaborators

  • University of Cologne

    lead OTHER

Principal Investigators

  • Roman-Ulrich Müller, Prof. · Department II of Internal Medicine, University of Cologne

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-10
Primary Completion
2022-08-12
Completion
2022-08-12

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04680780 on ClinicalTrials.gov