Controlled Diet for Kidney Stone Prevention

Overseen By Sonia Fargue, M.D., Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Kidney stones, Diabetes, Hepatic disease, others

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

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

Trial Summary

What is the purpose of this trial?

There is increasing evidence that obesity is associated with increased urinary oxalate excretion, an important risk factor for calcium oxalate stone formation. By the administration of a controlled low oxalate diet the investigators will estimate endogenous oxalate synthesis in both non-obese and obese non-kidney-stone forming adults. This study seeks to thusly increase the understanding of the relationships between obesity and endogenous oxalate synthesis to serve as a platform to develop novel therapies for stone prevention.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Controlled Diet, Dietary Intervention, Nutritional Therapy for kidney stone prevention?

Research shows that dietary advice alone can reduce factors in urine that lead to kidney stones, and combining nutritional guidance with other therapies can help prevent stones from coming back. ^{1 2 3 4 5}

Is a controlled diet for kidney stone prevention safe for humans?

Research shows that dietary changes, like those in the DASH diet, are generally safe and can reduce the risk of kidney stones. These diets emphasize fruits, vegetables, and low-fat dairy while limiting sodium and red meat, which are safe components for most people. ^{1 5 6 7 8}

How is the Controlled Diet treatment for kidney stone prevention different from other treatments?

The Controlled Diet treatment for kidney stone prevention is unique because it focuses on personalized dietary changes to reduce stone risk, rather than relying solely on medication. This approach involves adjusting fluid intake, calcium, sodium, and animal protein in the diet, tailored to each individual's specific needs and stone risk factors. ^{1 4 7 9 10}

Research Team

Dean G Assimos, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for adults aged 25-60 who are not obese (BMI <50) and have no history of kidney stones, diabetes, liver or renal diseases, bowel or other endocrine disorders. Pregnant women or those planning to become pregnant soon cannot participate.

Inclusion Criteria

Your Body Mass Index (BMI) is less than 50.

I am between 25 and 60 years old.

Exclusion Criteria

I have had kidney stones in the past.

I have a history of diabetes, liver, kidney, bowel diseases, or other hormone-related conditions.

My liver enzymes are abnormal.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention

Participants are placed on a controlled low oxalate diet to estimate endogenous oxalate synthesis

12 days

Daily monitoring

Assessment

Participants receive oral doses of 13C2-glycolate and 13C6-vitamin C to determine conversion to 13C2-oxalate and assess body morphometric indices, oxidative stress, and insulin resistance

Concurrent with dietary intervention

Follow-up

Participants are monitored for safety and effectiveness after the dietary intervention

4 weeks

Treatment Details

Interventions

• Controlled Diet

Trial Overview The study is testing the impact of a controlled low oxalate diet on non-obese and obese individuals without kidney stones. The goal is to understand how obesity affects the body's production of oxalate, which could lead to new treatments for preventing kidney stones.

Participant Groups

Group I: 20-24.9 BMI Active Control 1 Intervention

Participants with a BMI that falls between 20 and 24.9 who will receive the controlled diet

Group II: 25-29.9 BMI Active Control 1 Intervention

Participants with a BMI that falls between 25 and 29.9 who will receive the controlled diet

Group III: 30-34.9 BMI Active Control 1 Intervention

Participants with a BMI that falls between 30 and 34.9 who will receive the controlled diet

Group IV: 35-39.9 BMI Active Control 1 Intervention

Participants with a BMI that falls between 35 and 39.9 who will receive the controlled diet

Group V: 40-44.9 BMI Active Control 1 Intervention

Participants with a BMI that falls between 40 and 44.9 who will receive the controlled diet

Group VI: 45-50 BMI Active Control 1 Intervention

Participants with a BMI that falls between 45 and 50 who will receive the controlled diet.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

A combined nutritional and medical therapy approach significantly improved urinary risk factors for stone disease in 137 patients over an average follow-up of 14.39 months, with notable improvements in hypocitraturia (67% of patients), hypercalciuria (82%), and hyperuricosuria (72%).

The study highlights that individualized medical management based on specific urinary abnormalities can effectively reduce stone risk, especially for patients who do not respond to dietary changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-centered medical therapy for nephrolithiasis. Marchini, GS., Ortiz-Alvarado, O., Miyaoka, R., et al.[2013]

In a study of 242 patients with calcium-containing kidney stones, those who received specific dietary therapy tailored to their metabolic needs had a significantly lower recurrence rate of stones (6%) compared to those who followed general dietary advice (19%).

The results suggest that personalized dietary counseling is crucial for preventing future kidney stones, highlighting the importance of tailored interventions over generic recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective study of nonmedical prophylaxis after a first kidney stone. Kocvara, R., Plasgura, P., Petrík, A., et al.[2019]

Dietary advice alone did not significantly reduce urinary supersaturation in most patients with idiopathic calcium urolithiasis, but it did lower calcium oxalate and uric acid supersaturation in 19% of patients who complied well with the recommendations.

Effective dietary management requires a balanced focus on both increasing fluid intake to over 2,000 ml/day and reducing meat protein intake, as these factors are interconnected and crucial for lowering the risk of stone formation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a 'common sense diet' on urinary composition and supersaturation in patients with idiopathic calcium urolithiasis. Hess, B., Mauron, H., Ackermann, D., et al.[2018]

In a study of 57 patients with recurrent urolithiasis followed for 5 years, individualized dietary advice and pharmacological treatment led to significant reductions in urinary excretion of calcium, uric acid, and sodium.

The combination of these interventions also resulted in a significant decrease in the recurrence of kidney stones compared to pre-treatment levels, highlighting the effectiveness of tailored clinical therapy and nutrition in managing urolithiasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of clinical therapy and nutritional counseling on the recurrence of urolithiasis. Damasio, PC., Amaro, CR., Padovani, CR., et al.[2019]

In a study of 112 patients who received dietary recommendations to prevent kidney stones, patients recalled about 67% of the advice given, with better recall for key recommendations like increasing fluid intake and reducing meat consumption.

Patients who received fewer than four dietary recommendations had a higher recall rate (47% recalled all recommendations) compared to those given more than three, suggesting that simplifying dietary advice may improve patient adherence and understanding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with patient recall of individualized dietary recommendations for kidney stone prevention. Penniston, KL., Wertheim, ML., Nakada, SY., et al.[2018]

A DASH-style diet, which emphasizes fruits, vegetables, and low-fat dairy while reducing sodium and processed foods, is linked to a significant reduction in the risk of developing kidney stones, as shown in a study involving over 240,000 participants across three large health studies over up to 18 years.

Men and women with the highest DASH scores had relative risks of kidney stones that were 45-40% lower compared to those with the lowest scores, indicating that this diet may be particularly effective in preventing kidney stone formation, regardless of calcium intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DASH-style diet associates with reduced risk for kidney stones. Taylor, EN., Fung, TT., Curhan, GC.[2022]

Dietary modifications can significantly reduce the risk of developing kidney stones (nephrolithiasis) for many patients, potentially eliminating the need for medication.

Key dietary recommendations for stone prevention include maintaining adequate fluid intake, consuming modest amounts of calcium, reducing sodium intake, and limiting animal protein, all of which are supported by practice guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and Stone Disease in 2022. Dai, JC., Pearle, MS.[2022]

Patients with nephrolithiasis (kidney stones) showed higher body mass index and body fat percentage compared to controls, indicating a significant association between obesity and kidney stone formation.

The study found that nephrolithiasis patients had significantly higher oxalate intake than controls, and 30% of these patients exhibited hypercalciuria, suggesting that dietary management and obesity prevention are crucial in treating and preventing kidney stones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adequate dietary intake and nutritional status in patients with nephrolithiasis: new targets and objectives. Oliveira, LM., Hauschild, DB., Leite, Cde M., et al.[2014]

Nutritional factors play a significant role in the prevention of kidney stones, particularly calcium-containing and uric acid stones, and are often included in treatment plans for patients at risk.

The article emphasizes the importance of both general and tailored nutritional approaches to address specific risk factors for kidney stone formation, highlighting the need for assessing individual nutrition risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and alternative therapies in the management of stone disease. Penniston, KL., Nakada, SY.[2012]

Diet plays a significant role in urinary stone disease, and personalized dietary modifications can help reduce the risk of stone formation by addressing individual urinary risk factors and dietary preferences.

The development of a new 40-item stone-specific food screener aims to provide a standardized tool for assessing dietary risk factors related to stone disease, although further validation is needed for its broader use in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and Kidney Stones: The Ideal Questionnaire. Penniston, KL.[2022]

References

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

Patient-centered medical therapy for nephrolithiasis. [2013]

2. England pubmed.ncbi.nlm.nih.gov

A prospective study of nonmedical prophylaxis after a first kidney stone. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of a 'common sense diet' on urinary composition and supersaturation in patients with idiopathic calcium urolithiasis. [2018]

4. Brazil pubmed.ncbi.nlm.nih.gov

Influence of clinical therapy and nutritional counseling on the recurrence of urolithiasis. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Factors associated with patient recall of individualized dietary recommendations for kidney stone prevention. [2018]

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

DASH-style diet associates with reduced risk for kidney stones. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Diet and Stone Disease in 2022. [2022]

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

Adequate dietary intake and nutritional status in patients with nephrolithiasis: new targets and objectives. [2014]

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

Diet and alternative therapies in the management of stone disease. [2012]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Diet and Kidney Stones: The Ideal Questionnaire. [2022]