Diet Impact on Kidney Stones in Obese Individuals
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how diet affects kidney stones in individuals who are obese and form calcium oxalate stones. Researchers aim to understand how the body processes oxalate, a compound in many foods, and its role in kidney stone formation. Participants will follow a specific controlled diet, also known as a dietary intervention or nutritional therapy, for a few days while researchers monitor their urine and blood. Suitable candidates have experienced calcium oxalate kidney stones (comprising more than 50% of the stone) and are willing to adhere to a set diet and pause certain supplements and medications. As an unphased trial, this study provides a unique opportunity to advance scientific understanding of diet's impact on kidney stones.
Will I have to stop taking my current medications?
Yes, you will need to stop taking medications for kidney stone prevention, like thiazides, allopurinol, febuxostat, and citrate preparations, for 14 days before the study starts and during the study. You can restart these medications after the study ends.
What prior data suggests that this dietary intervention is safe?
Research shows that changing one's diet can safely help manage kidney stones. Studies have found that adjusting eating habits can reduce the risk of developing new stones, especially the common type made of calcium oxalate. A diet with normal amounts of calcium, less salt, and less meat proves more effective at preventing stones than merely reducing calcium intake.
Importantly, following a diet to prevent kidney stones has not raised any serious safety concerns. Most individuals can adhere to these diets without major issues, making dietary changes a safe option for managing or preventing kidney stones.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores the impact of a controlled diet on kidney stones in obese individuals, a group that often struggles with this painful condition. Unlike traditional treatments that might focus on medications or surgery to manage kidney stones, this approach uses a tailored diet to potentially reduce stone formation naturally. By monitoring how diet changes affect urine composition and absorption of certain substances, researchers aim to uncover new dietary strategies that might prevent kidney stones more effectively, offering a non-invasive and lifestyle-centered option.
What evidence suggests that this controlled diet is effective for kidney stones?
Research has shown that dietary changes can significantly reduce the risk of kidney stones. This trial will assess the effects of a controlled diet on kidney stone formation in obese individuals. One study found that a diet with normal calcium levels and reduced animal protein lowered the recurrence of stones by 51%. Other studies have discovered that low-fat or low-calorie diets aid in weight loss and might also decrease the risk of stone formation. Improved diet quality is associated with a reduced likelihood of developing kidney stones. These findings suggest that dietary changes could effectively manage and prevent kidney stones, particularly for overweight individuals.678910
Who Is on the Research Team?
Dean G Assimos, MD
Principal Investigator
University of Alabama at Birmingham
Are You a Good Fit for This Trial?
This trial is for adults with normal (BMI ≥ 18.5 to < 25) or obese (BMI ≥ 30 to ≤ 45) who form calcium oxalate kidney stones, can consent, and follow a controlled diet without vigorous exercise. Excluded are those with diabetes, abnormal blood tests, certain kidney diseases, gastrointestinal disorders affecting oxalate transport, recent cancer treatment, pregnancy or breastfeeding women not using birth control.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Controlled Dietary Study
Participants consume a controlled diet for five days, provide urine collections, and undergo blood sampling after ingesting carbon-13 oxalate and sucralose
Follow-up
Participants are monitored for safety and effectiveness after the controlled dietary study
What Are the Treatments Tested in This Trial?
Interventions
- Controlled Diet
Trial Overview
The study investigates how obesity affects the body's processing of oxalate in people prone to calcium oxalate kidney stones. Participants will follow a controlled diet and ingest Carbon-13 Oxalate and Sucralose to track their metabolism and urinary excretion patterns.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Participants will consume the controlled diet for five days. After one day on the diet, subjects will provide three 24-hour urine collections. On the last dayof the diet, subjects will come in a fasted state to ingest a small amount of carbon-13 oxalate and sucralose, with hourly urine collections and blood samples being taken before and after the ingestion.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
University of Texas, Southwestern Medical Center at Dallas
Collaborator
Published Research Related to This Trial
Citations
Nutritional Management of Kidney Stones (Nephrolithiasis)
Patients who consumed a diet with a normal calcium intake (i.e., 1,200 mg/d) plus a low animal protein intake had a 51% lower incidence of recurrent stones than ...
Prospects for Dietary Therapy of Recurrent Nephrolithiasis
Randomized trials show that diets consisting of low-fat content or low-caloric content cause modest weight loss and might be effective in reducing stone ...
Dietary weight loss strategies for kidney stone patients
An energy-restricted diet with or without meal replacement could be a promising weight loss strategy for overweight kidney stone patients.
Healthy dietary patterns, biological aging, and kidney stones
Conclusion: These findings provide valuable insights into the complex interplay between dietary patterns, biological aging, and the risk of kidney stone.
Nutrition therapy for the prevention of kidney stones
Improved diet quality has been associated with a lower risk of kidney stones (12). The cross-sectional National Health and Nutrition Examination Surveys have ...
Dietary and lifestyle factors for primary prevention of ...
Another RCT showed that a DASH-style diet nonsignificantly decreased urine calcium oxalate supersaturation among stone formers with ...
Nutrition and Kidney Stone Disease - PMC
Diet modification is an effective method to correct urinary risk factors for kidney stone formation, particularly of the most common stone type calcium oxalate.
Kidney Stone Diet Plan and Prevention
Learn about managing kidney stones with a specialized diet. Discover the role of hydration, types of kidney stones, and dietary tips for prevention.
Diet, Fluid, or Supplements for Secondary Prevention of ...
High fluid intake decreased risk of recurrent nephrolithiasis. Reduced soft drink intake lowered risk in patients with high baseline soft drink consumption.
Kidney Stones: Medical Mangement Guideline
A multicomponent diet consisting of normal calcium, low sodium, low animal protein intake was shown to be superior to a low calcium diet in preventing stone ...
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