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Dietary Supplement

Dietary Oxalate Impact on Kidney Stones

N/A

Waitlist Available

Led By Tanecia Mitchell, PhD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy subjects (men and women) between the ages of 18 and 60 years of age

No calcium oxalate kidney stones or other medical conditions

Must not have

History of kidney stones or any medical condition that could influence absorption or excretion of oxalate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 3-4 and 13-14

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether a high-oxalate diet impacts the formation of urinary crystals and the immune system in healthy subjects.

Who is the study for?

This trial is for healthy men and women aged 18-60, with a BMI of 20-30, who don't smoke or have kidney stones. Participants must not be pregnant, should avoid vigorous exercise and supplements during the study, and be willing to follow specific diets while collecting urine samples.

What is being tested?

The study investigates how different levels of dietary oxalate affect urinary crystals formation and immune response in healthy individuals. It involves adhering strictly to either a low or high oxalate diet provided by the researchers.

What are the potential side effects?

Since this trial involves dietary changes rather than medication, side effects may include digestive discomfort depending on individual tolerance to low or high oxalate foods.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 60 years old and consider myself healthy.

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I do not have kidney stones or other medical conditions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had kidney stones or conditions affecting how my body handles oxalate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 3-4 and 13-14

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 3-4 and 13-14

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 3-4 and 13-14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Body Weight Changes

Change in Monocyte Cellular Energetics and Mitochondrial Function

Change in Monocyte Subtypes

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Low Oxalate Diet Followed by High Oxalate DietExperimental Treatment2 Interventions

Subjects will consume a low oxalate diet for four days, with blood and 24-hour urine collections occurring at baseline and post diet. A ten day wash out period will follow, during which the subject will consume a self-selected diet. Subjects will then consume the high oxalate diet for the final four days, with blood and 24-hour urine collections once again occurring at baseline and post diet.

Group II: High Oxalate Diet Followed by Low Oxalate DietExperimental Treatment2 Interventions

Subjects will consume a high oxalate diet for four days, with blood and 24-hour urine collections occurring at baseline and post diet. A ten day wash out period will follow, during which the subject will consume a self-selected diet. Subjects will then consume the low oxalate diet for the final four days, with blood and 24-hour urine collections once again occurring at baseline and post diet.

0 / 3Eligibility criteria met