Dietary Intervention for Polycystic Kidney Disease

(ADPKD Trial)

Overseen By Sayna Norouzi, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Loma Linda University

Must not be taking: Tolvaptan

Disqualifiers: Diabetes, Heart failure, Advanced CKD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 12 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this interventional study is to evaluate the impact of a specific diet (low salt, limited caffeine, high potassium, low phosphate, limited protein, limited carbohydrate intake, adequate water intake) on changes in serum and urinary biomarkers, total kidney volume (TKV), and cyst progression in subjects with autosomal dominant polycystic kidney disease (ADPKD). Researchers will compare the results of subjects in the study diet (interventional) arm to the results of subjects in the regular diet (control) arm.

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 cannot participate if you are taking Tolvaptan.

Is the dietary intervention for polycystic kidney disease safe for humans?

Current research suggests that dietary interventions, like caloric restriction and ketogenic diets, are generally safe and may offer metabolic benefits, but more human trials are needed to confirm their safety and effectiveness specifically for polycystic kidney disease. ^{1 2 3 4 5}

How does the dietary intervention treatment for polycystic kidney disease differ from other treatments?

The dietary intervention for polycystic kidney disease is unique because it focuses on controlling dietary factors like sodium, protein, and acid intake, which may influence cyst growth, rather than relying on medications. This approach aims to slow disease progression by modifying nutrient signaling and metabolism, offering a potentially safer and cost-effective alternative to drug treatments. ^{2 4 6 7 8}

What data supports the effectiveness of the dietary intervention treatment for Polycystic Kidney Disease?

Research suggests that dietary interventions like caloric restriction, intermittent fasting, and ketogenic diets may help slow the progression of polycystic kidney disease by affecting nutrient signaling and metabolism. Additionally, studies in mice have shown that food restriction can reduce cyst growth and kidney damage, indicating potential benefits for humans. ^{1 2 4 5 9}

Who Is on the Research Team?

Amir Abdipour, MD

Principal Investigator

Loma Linda University Health

Are You a Good Fit for This Trial?

This trial is for people with autosomal dominant polycystic kidney disease (ADPKD). Participants should be willing to follow a specific diet plan. The exact eligibility criteria are not provided, but typically include factors like age range, stage of the disease, and overall health status.

Inclusion Criteria

I have been diagnosed with ADPKD.

Willingness to adhere to a preconditioning diet for 1 week and ability to complete the study

My kidney function is above the minimum level required.

Exclusion Criteria

I do not have severe diabetes, heart failure, or advanced kidney disease.

History of dietary non-adherence

I am currently taking Tolvaptan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preconditioning

All subjects follow the study diet for one week, after which serum and urinary biomarkers are measured

1 week

1 visit (in-person)

Treatment

Subjects follow either the interventional or regular diet for 12 months with follow-up visits to assess adherence and measure biomarkers

12 months

6 visits (in-person) at months 1, 2, 3, 6, 9, and 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Interventional Diet

Trial Overview The study tests how a special diet affects ADPKD. This diet includes low salt, limited caffeine and protein, high potassium, low phosphate, controlled carbs, and proper water intake. Researchers will compare changes in biomarkers and kidney size between those on this diet versus a regular diet.

How Is the Trial Designed?

Group I: Interventional Diet Experimental Treatment 1 Intervention

Subjects will follow a specified diet (low salt, limited caffeine, high potassium, low phosphate, and limited protein and carbohydrate intake along with adequate water intake) after 1 week of preconditioning for 12 months.

Group II: Regular Diet Active Control 1 Intervention

Subjects will follow the diet they normally adhere to after 1 week of preconditioning.

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

Published Research Related to This Trial

Recent research highlights the potential of dietary modifications as a strategy to prevent or slow the progression of polycystic kidney disease (PKD), alongside emerging drug treatments like vasopressin-receptor agonists.

The review summarizes current evidence on how specific nutrients and dietary patterns may influence cyst growth and disease progression in PKD, suggesting that evidence-based dietary interventions could play a significant role in managing the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and Polycystic Kidney Disease: Nutrients, Foods, Dietary Patterns, and Implications for Practice. Lambert, K., Gardos, R., Coolican, H., et al.[2023]

Recent evidence suggests that specific dietary regimens, such as caloric restriction, intermittent fasting, and ketogenic diets, may help slow the progression of autosomal dominant polycystic kidney disease (ADPKD) by influencing nutrient signaling in the kidneys.

The review highlights the potential for these dietary interventions to not only impact kidney health but also provide systemic metabolic benefits, with ongoing human clinical trials expected to provide further insights.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Interventions in Autosomal Dominant Polycystic Kidney Disease. Pickel, L., Iliuta, IA., Scholey, J., et al.[2023]

In a study using a murine model of polycystic kidney disease (PKD), early dietary protein restriction significantly reduced cyst growth, with low protein diets leading to an 11% lower percentage of cyst area and a 46% lower total cyst area compared to normal protein diets.

The type of dietary oil (sunflower seed oil vs. fish oil) did not affect disease progression, suggesting that the amount of protein in the diet is more critical for managing PKD than the type of fat consumed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of dietary protein restriction and oil type on the early progression of murine polycystic kidney disease. Aukema, HM., Ogborn, MR., Tomobe, K., et al.[2019]

Food restriction (FR) in mouse models of autosomal dominant polycystic kidney disease (ADPKD) significantly slows disease progression by reducing cyst area, renal fibrosis, inflammation, and injury in a dose-dependent manner.

The beneficial effects of FR are linked to the suppression of the mTOR pathway and activation of the LKB1/AMPK pathway, suggesting that dietary interventions could be a novel therapeutic approach for managing ADPKD in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food Restriction Ameliorates the Development of Polycystic Kidney Disease. Warner, G., Hein, KZ., Nin, V., et al.[2018]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Diet and Polycystic Kidney Disease: Nutrients, Foods, Dietary Patterns, and Implications for Practice. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Dietary Interventions in Autosomal Dominant Polycystic Kidney Disease. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Modification of polycystic kidney disease and fatty acid status by soy protein diet. [2006]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of dietary protein restriction and oil type on the early progression of murine polycystic kidney disease. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Food Restriction Ameliorates the Development of Polycystic Kidney Disease. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Dietary modulation of p-nonylphenol-induced polycystic kidneys in male Sprague-Dawley rats. [2016]

7. England pubmed.ncbi.nlm.nih.gov

Diet and polycystic kidney disease: A pilot intervention study. [2018]

8. Italy pubmed.ncbi.nlm.nih.gov

Nutritional therapy in autosomal dominant polycystic kidney disease. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Evidence for a role of proteins, lipids, and phytochemicals in the prevention of polycystic kidney disease progression and severity. [2018]