Effects of Exogenous Ketosis on Proteinuria and Renal Function
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ketone Diol, R-1,3-butanediol (Ketone-IQ), Placebo drink.
- Who it may be relevant to
- Registry conditions: Renal Insufficiency, Chronic, Polycystic Kidney Diseases, Proteinuria, Ketosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Exogenous Ketosis on Proteinuria and Renal Function in Patients with Chronic Kidney Disease and Patients with Polycystic Kidney Disease
Overview
A randomized, placebo-controlled, double-blinded crossover study will be conducted. Fourteen patients with polycystic kidney disease (PKD) and 29 patients with proteinuric kidney disease will receive ketone bodies (Ketone-IQ) and placebo in a randomized order. Each treatment period is four weeks. There will be a wash-out period of two weeks in between treatment periods. Effect variables will be measured in the last day of each treatment period.
Detailed description
Background: Until recently, the only treatment shown to slow progression of chronic kidney disease (CKD) has been angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs).
The use of sodium glucose transporter 2 (SGLT2)-inhibitors, which work by blocking the activity of sodium-glucose-cotransporter 2 channels in the proximal kidney tubule, has completely transformed the treatment of proteinuric kidney disease, with a 28% decrease in the risk for cardiorenal outcomes. Despite these new treatment options, a significant proportion of patients still succumb to kidney failure, require hospitalization for heart failure and die prematurely. Thus, additional preventive measures are essential.
Renewed interest in the physiological role of ketone bodies (KB) has emerged. It has become increasingly clear that ketosis has several beneficial effects including anti-epileptic effects, improved exercise capacity, lipid profile, cardiac function and cognition.
However, only few clinical studies have studied renal effects of exogenous ketosis, and to our knowledge there are no clinical studies examining the effects long term effects of renal ketosis in patients with CKD.
Hypothesis: Ketosis decreases urine albumin to creatinine ratio (ACR) and glomerular filtration rate (GFR) in patients with CKD/PKD.
Methods: A randomized, placebo-controlled, double-blinded crossover study will be conducted. Twenty-nine patients with proteinuric kidney disease (study a) and 14 patients with PKD (study b) will receive ketone bodies (Ketone-IQ) and placebo in a randomized order. Each treatment period is four weeks. There will be a wash-out period of two weeks in between treatment periods. Effect variables will be measured in the last day of each treatment period.
Perspectives: The study has the potential to provide information regarding the therapeutic potential of ketone bodies in patients with CKD/PKD.
Interventions
- Dietary supplement Ketone Diol, R-1,3-butanediol (Ketone-IQ)
Effect variables will be measured on the last day of treatment with Ketone-IQ - Other Placebo drink
Effect variables will be measured on the last day of treatment with Placebo
Primary outcome measures
- Proteinuria [Time frame: Measured on 24 hour urine collection on the last day in each treatment period (each treatment period is 4 weeks)]
- GFR [Time frame: Measured on the last day in each treatment period (each treatment period is 4 weeks)]
Secondary outcome measures (9)
- Aldosterone [Time frame: Measured on the last day in each treatment period (each treatment period is 4 weeks)]
- P-Beta-hydroxybutyrate [Time frame: Measured on the last day in each treatment period (each treatment period is 4 weeks)]
- Excretion rate of renal tubular transport proteins [Time frame: Measured on the last day in each treatment period (each treatment period is 4 weeks)]
- 24-hour Ambulatory Blood Pressure [Time frame: Measured using a Mobil-o-graph on the last day in each treatment period (each treatment period is 4 weeks)]
- Sodium and potassium excretion [Time frame: Measured on 24 hour urine collection on the last day in each treatment period (each treatment period is 4 weeks)]
- Peripherial Vascular Resistance [Time frame: Measured using a Mobil-o-graph on the last day in each treatment period (each treatment period is 4 weeks)]
- Heart rate [Time frame: Measured using a Mobil-o-graph on the last day in each treatment period (each treatment period is 4 weeks)]
- Pulse Wave Velocity [Time frame: Measured using a Mobil-o-graph on the last day in each treatment period (each treatment period is 4 weeks)]
- Renin [Time frame: Measured on the last day in each treatment period (each treatment period is 4 weeks)]
Eligibility criteria
Inclusion criteria
Study A (patients with CKD):
- ACR > 200 mg/g <3000 mg/g
- eGFR >30 ml/min/1,73m2
- Treatment with Renin-Angiotension System (RAS) blockers and SGLT-2 inhibitors for a minimum of 4 weeks prior to inclusion
- Safe contraception if women in childbearing age
Study B (patients with PKD):
- Prior diagnose with PKD
- eGFR >30 ml/min/1,73m2
- Treatment with Renin-Angiotension System (RAS) blockers for a minimum of 4 weeks prior to inclusion
- Safe contraception if women in childbearing age
Exclusion Criteria (Study A+B)
- Diabetes Mellitus type 1
- Heart Failure
- Liver Disease
- Kidney transplant
- Malignant diseases (except skin cancer)
- Recent acute myocardial infarction (AMI), apoplexia/transient ischemic attack (TIA) (within 3 months of inclusion)
- Pregnancy or breast feeding
- Alcohol or drug abuse
- Periodic fasting within four weeks of inclusion
- Routinely intake of ketogenic diet within four weeks of inclusion
- Treatment with nitrate
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Denmark · 1 center
- University Clinic in Nephrology and Hypertension, Gødstrup Region Hospital — Herning
Identifiers
NCT: NCT06867471 · TZL-2-2024