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Understanding Oxalate and Kidney Stones

This study is investigating how oxalate, a substance found in many foods, affects kidney stone formation and the body's immune system. Researchers want to understand if different levels of oxalate in your diet can change how crystals form in your urine and how your immune system responds. You would be asked to follow specific diets: a Low Oxalate Diet and a High Oxalate Diet. The study will measure changes in urinary oxalate, crystal formation (nanocrystalluria), and immune cell function. This study is for healthy adults and those with calcium oxalate kidney stones, aged 18-60, with a BMI between 20-30. You cannot be a tobacco user, pregnant, or breastfeeding. You will also need to have normal results on certain blood and urine tests. The study aims to enroll 88 participants, but its current recruitment status is unclear.

Study design
This interventional study plans to enroll 88 participants, including healthy individuals and those with kidney stones. Participants will switch between a low and high oxalate diet over approximately three weeks.
What's involved
You would be in the study for about 3 weeks, consuming controlled diets provided to you. You would also provide blood and urine samples, and be asked not to take dietary supplements, exercise strenuously, or eat outside of the provided food.
Compensation
Not stated in the trial record.
Follow-up
Urinary oxalate and nanocrystalluria will be measured at Days 3-4 and 13-14. Monocyte cellular bioenergetics and mitochondrial function will be measured at Day 1.

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NCT05417568

Oxalate-Driven Host Responses in Kidney Stone Disease

Recruiting
NAAges 18–60InterventionalBasic science
University of Alabama at Birmingham
~88 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:Low Oxalate DietHigh Oxalate Diet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Urinary Oxalate
Measured over Days 3-4 and 13-14
+13 more outcomes measured

Conditions

Kidney Stones

Explore related trials

Nephrolithiasis

Where it's being run

1 sites across 1 states
Alabama1

Study leadership

  • Tanecia Mitchell, PhD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham

Who to contact

Tanecia Mitchell, PhD
[email protected]
(205) 996-2292
Email the study team

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Eligibility criteria

Inclusion

Men and women between the ages of 18 and 60 years old.
Able to provide informed consent.
BMI between 20-30 kg/m2.
Non-tobacco users or not pregnant/breastfeeding/nursing.
Normal fasting blood comprehensive metabolic panel, complete blood count, C-reactive protein, and urinalysis. Must accurately collect two 24-hour urine collections within 20% of the appropriate ratio of creatinine (mg)/body weight (kg) for respective gender.
Healthy subjects: No history of CaOx KS or other medical conditions.
Patients with CaOx KS: Recent stone composition \> 50% CaOx; no uric acid, struvite, or carbonate apatite stone content. Must be first-time or recurrent CaOx stone former (last stone event ≤ 3 years).
Willing to not consume supplements (i.e. vitamins, Ca (citrate or carbonate) and other minerals, herbal supplements, nutritional aids, and probiotics) for 2 weeks before the study and during the study.
Willing to abstain from vigorous exercise during the study as this may compromise immune function.
Willing to consume diets provided only by the UAB CCTS Bionutrition Core. No food allergies or intolerance to any of the foods on the study menus.
Willing to accurately collect 24-hour urine samples, and to have blood drawn throughout the study.
If on medications for KS prevention (e.g. thiazides, citrate supplementation excluding calcium citrate), patients must be on a stable dose regimen for at least 8 weeks prior to and during screening, with no changes in dosing anticipated during the study. Patients should not take allopurinol for 2 weeks prior to screening since allopurinol has antioxidant properties.
Inability to sign and read the informed consent.
Any medical, psychiatric, or social conditions that would prohibit participants from abiding by the study requirements.
BMI ˃30 kg/m2 and \<20 kg/m2
Tobacco users or pregnant or breastfeeding/nursing women.
Abnormal fasting blood comprehensive metabolic panel, complete blood count, C-reactive protein, and urinalysis. Inaccurate 24-hour urine collections.
Healthy subjects: Currently taking or have recently taken medications within the last 3 months (i.e. antibiotics) or dietary supplements. History of KS or any medical condition that could influence absorption or excretion of oxalate.
Active illness including COVID-19, flu, common cold, fever, diarrhea, urinary tract infections, or other infections 14 days before the study and throughout the study.

What this trial measures

  • Change in Urinary OxalateDays 3-4 and 13-14

    Twenty-four hour urinary oxalate will be reported as mg/day.

  • Change in NanocystalluriaDays 3-4 and 13-14

    Nanocrystalluria will be reported as particles/ml.

  • Monocyte Cellular Bioenergetics and Mitochondrial FunctionDay 1

    Cellular bioenergetics and mitochondrial function will be reported as oxygen consumption rate (pmol/min/10,000 cells).

  • Monocyte Cellular Bioenergetics and Mitochondrial FunctionDay 4

    Cellular bioenergetics and mitochondrial function will be reported as oxygen consumption rate (pmol/min/10,000 cells).

  • Monocyte Cellular Bioenergetics and Mitochondrial FunctionDay 11

    Cellular bioenergetics and mitochondrial function will be reported as oxygen consumption rate (pmol/min/10,000 cells).

  • Monocyte Cellular Bioenergetics and Mitochondrial FunctionDay 14

    Cellular bioenergetics and mitochondrial function will be reported as oxygen consumption rate (pmol/min/10,000 cells).

  • Monocyte SubtypesDay 1

    Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).

  • Monocyte SubtypesDay 4

    Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).

  • Monocyte SubtypesDay 11

    Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).

  • Monocyte SubtypesDay 14

    Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).

  • Monocyte TranscriptomicsDay 1

    Monocyte transcriptomics will be reported as gene expression (mRNA levels)

  • Monocyte TranscriptomicsDay 4

    Monocyte transcriptomics will be reported as gene expression (mRNA levels)

  • Monocyte TranscriptomicsDay 11

    Monocyte transcriptomics will be reported as gene expression (mRNA levels)

  • Monocyte TranscriptomicsDay 14

    Monocyte transcriptomics will be reported as gene expression (mRNA levels)