20 Participants Needed

Ketogenic Diet for Kidney Disease

ML
JV
Overseen ByJeff Volek, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ohio State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not have changed medications in the last three months to be eligible.

What data supports the effectiveness of the treatment Ketogenic Diet, High Fat, Low Carb Diet for kidney disease?

The study on the ketogenic diet for CKD patients aims to explore its impact on weight loss and metabolic changes, which could indirectly benefit kidney health by reducing obesity-related stress on the kidneys. While direct evidence for kidney disease is limited, the ketogenic diet has shown effectiveness in weight loss and metabolic improvements in other conditions, which may suggest potential benefits for CKD patients.12345

Is the ketogenic diet safe for people with kidney disease?

Research suggests that a very low-calorie ketogenic diet can be safe for weight loss in people with obesity and mild kidney failure when supervised by healthcare professionals, showing no significant harm to kidney function. However, there are reports of potential complications like hypercalcemia (high calcium levels in the blood) in children using the ketogenic diet, indicating the need for careful monitoring.13678

How is the ketogenic diet treatment different from other treatments for kidney disease?

The ketogenic diet is unique for kidney disease as it focuses on high fat and low carbohydrate intake, which is different from the typical low-protein diets often recommended for kidney health. This diet is being studied for its potential benefits in weight loss and metabolic changes in patients with mild-to-moderate chronic kidney disease and obesity, which is not a common focus of traditional kidney disease treatments.19101112

What is the purpose of this trial?

This is a prospective study to determine ketogenic diet effect on htTKV, GFR, microalbuminuria. This is a single-center study of 20 patients with ADPKD and deemed high risk for progression to ESRD. This determined by combination of features of ADPKD and htTKV as assessed by prior computed tomography (CT) or MRI. Patients will be recruited from the Polycystic Kidney Disease (PKD) Clinic at Ohio State University Wexner Medical Center. Enrolled patients will have MRI for htTKV, urinary studies, blood tests at baseline, 6 months, and 52 weeks. Blood for GFR will be assessed three times over the course of the study including baseline, 6 months, and 1 year. Participants will follow ketogenic diet for 52 weeks. Investigatory diet team will manage the ketogenic diet.

Eligibility Criteria

This trial is for adults aged 18-65 with Polycystic Kidney Disease at high risk of kidney failure, specifically those classified as Mayo Class 1C-1E. Participants should be able to follow a ketogenic diet and have stable medication use for the last three months. They must also have a GFR (a measure of kidney function) of at least 25 mg/dl.

Inclusion Criteria

I haven't changed my medications in the last 3 months.
I can follow the required diet plan.
I have been diagnosed with ADPKD through imaging or genetic tests.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a ketogenic diet for 52 weeks with monitoring of htTKV, GFR, and microalbuminuria

52 weeks
3 visits (in-person) at baseline, 6 months, and 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Ketogenic Diet
Trial Overview The study tests how a well-formulated ketogenic diet affects kidney size, function, and protein leakage in urine over one year. It involves regular blood draws, monitoring ketone/glucose levels using CGM/CKM devices, MRI scans to assess changes in kidney volume and filtration rate, and body composition analysis.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Ketogenic DietExperimental Treatment6 Interventions
The KD will follow general principles the investigators have described with the aim to achieve blood ketones \>0.5 mM, which will require most participants to consume \<50 g/day carbohydrate and \~1.5 g/kg reference weight protein. Fat will comprise the remaining calories with an emphasis on monounsaturated and saturated sources from whole foods.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials
891
Recruited
2,659,000+

Findings from Research

This multicentre randomized controlled trial aims to evaluate the effects of a ketogenic diet on weight loss and metabolic changes in adult patients with mild-to-moderate chronic kidney disease (CKD) and obesity, enrolling participants with specific health criteria over a 6-month period.
The study will assess various outcomes, including weight loss, adherence to the diet, and changes in metabolic and renal function, to better understand the potential benefits and risks of the ketogenic diet for CKD patients.
The effect of a ketogenic diet on weight loss in CKD: a randomized controlled trial in obese stage G1-3a CKD patients.Zoccali, C., Bellizzi, V., Minutolo, R., et al.[2023]
In a study of 223 patients with chronic kidney disease (CKD) over a median of 74.2 months, a very low-protein diet supplemented with ketoanalogues (sVLPD) did not show a significant advantage over a standard low-protein diet (LPD) in terms of renal death or overall survival.
Both diets were safe, but adherence to protein restriction was low, and neither diet led to changes in nutritional status, indicating that while sVLPD is safe, it does not improve kidney outcomes compared to LPD.
No additional benefit of prescribing a very low-protein diet in patients with advanced chronic kidney disease under regular nephrology care: a pragmatic, randomized, controlled trial.Bellizzi, V., Signoriello, S., Minutolo, R., et al.[2023]
A meta-analysis of 17 randomized controlled trials involving 1,459 participants found that a restricted protein diet supplemented with ketoanalogues (KAs) significantly preserved kidney function (eGFR) and reduced proteinuria, blood pressure, and markers of CKD-mineral bone disorder.
The very low protein diet (VLPD) with KAs was more effective than a low protein diet (LPD) with KAs in slowing the decline of eGFR and improving blood pressure and parathyroid hormone levels, while both diets effectively decreased serum phosphate without causing malnutrition.
The Effects of Restricted Protein Diet Supplemented With Ketoanalogue on Renal Function, Blood Pressure, Nutritional Status, and Chronic Kidney Disease-Mineral and Bone Disorder in Chronic Kidney Disease Patients: A Systematic Review and Meta-Analysis.Chewcharat, A., Takkavatakarn, K., Wongrattanagorn, S., et al.[2022]

References

The effect of a ketogenic diet on weight loss in CKD: a randomized controlled trial in obese stage G1-3a CKD patients. [2023]
No additional benefit of prescribing a very low-protein diet in patients with advanced chronic kidney disease under regular nephrology care: a pragmatic, randomized, controlled trial. [2023]
The Effects of Restricted Protein Diet Supplemented With Ketoanalogue on Renal Function, Blood Pressure, Nutritional Status, and Chronic Kidney Disease-Mineral and Bone Disorder in Chronic Kidney Disease Patients: A Systematic Review and Meta-Analysis. [2022]
Ketoanalogue Supplementation in Patients with Non-Dialysis Diabetic Kidney Disease: A Systematic Review and Meta-Analysis. [2022]
Long-Term Effects of Ketoanalogues on Mortality and Renal Outcomes in Advanced Chronic Kidney Disease Patients Receiving a Low-Protein Diet. [2021]
Very Low-Calorie Ketogenic Diet: A Safe and Effective Tool for Weight Loss in Patients With Obesity and Mild Kidney Failure. [2020]
Hypercalcemia in Children Using the Ketogenic Diet: A Multicenter Study. [2021]
Effects of a supplemented hypoproteic diet in chronic kidney disease. [2022]
9.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Effects of keto/amino acids and a low-protein diet on the nutritional status of patients with Stages 3B-4 chronic kidney disease]. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Empiric use of potassium citrate reduces kidney-stone incidence with the ketogenic diet. [2021]
Better preservation of residual renal function in peritoneal dialysis patients treated with a low-protein diet supplemented with keto acids: a prospective, randomized trial. [2013]
12.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Soy protein as part of a low-protein diet is a new direction in cardio- and nephroprotection in patients with 3B-4 stages of chronic kidney disease: prospective, randomized, controlled clinical study]. [2022]
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