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Could your diet trigger kidney stones by changing your immune system?

NCT ID NCT04051346

Knowledge-focused Sponsor: University of Alabama at Birmingham Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looked at how eating high or low amounts of oxalate (a natural compound in many foods) affects urine crystals and immune cells in healthy adults. Fourteen participants followed two controlled diets to see if oxalate changes crystal formation and immune function. The goal is to better understand how diet might lead to kidney stones.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Low Oxalate Diet and High Oxalate Diet
What this could lead to
If successful, this could reveal how diet influences the immune system's role in kidney stone formation, pointing toward future prevention strategies.
What could go wrong
This is a small, early-stage study with only 14 healthy participants, not patients. Results may not apply to people with kidney stones or other conditions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

14 people

The number who actually took part.

Started

Mar 2021

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Healthy subjects (men and women) between the ages of 18 and 60 years of age * No calcium oxalate kidney stones or other medical conditions * Normal comprehensive metabolic panel (CMP) * Non tobacco users * Not pregnant * BMI between 20-30 kg/m2 * Willing to abstain from vigorous exercise and vitamins/supplements during the study * Willing to consume only provided diets, accurately collect 24-hour urine samples, and have blood drawn Exclusion Criteria: * Inability to sign and read the informed consent * Any medical, psychiatric, or social conditions that would prohibit participants from abiding by the study requirements * Physician refusal * Pregnant women * Active medical problems * History of kidney stones or any medical condition that could influence absorption or excretion of oxalate * Tobacco users * Taking medications or dietary supplements * BMI \>30 or \<20

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Conditions

The condition(s) this trial relates to.

Kidney Calculi nephrolithiasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Kidney stone

Contacts and locations

Locations

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.