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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 3-4 and 13-14

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Body Weight Changes

Change in Monocyte Cellular Energetics and Mitochondrial Function

Change in Monocyte Subtypes

+2 more

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 / 2Eligibility criteria met

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Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,581 Previous Clinical Trials

2,278,009 Total Patients Enrolled

14 Trials studying Kidney Stones

815 Patients Enrolled for Kidney Stones

Tanecia Mitchell, PhDPrincipal Investigator - University of Alabama at Birmingham

University of Alabama at Birmingham

3 Previous Clinical Trials

258 Total Patients Enrolled

3 Trials studying Kidney Stones

258 Patients Enrolled for Kidney Stones

Media Library

High Oxalate Diet (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04051346 — N/A

Kidney Stones Research Study Groups: High Oxalate Diet Followed by Low Oxalate Diet, Low Oxalate Diet Followed by High Oxalate Diet

Kidney Stones Clinical Trial 2023: High Oxalate Diet Highlights & Side Effects. Trial Name: NCT04051346 — N/A

High Oxalate Diet (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04051346 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the capacity of this clinical research endeavor?

"That is correct. According to the records stored on clinicaltrials.gov, this medical investigation began recruiting participants from March 5th 2021 and has been amending its requirements since then. Currently, 20 volunteers are required for a single location site."

Answered by AI

Is it possible for me to partake in this trial?

"For this medical experimentation, 20 individuals with kidney stones that are between 18-60 years old must be enlisted. To qualify for the trial, participants cannot use tobacco products, need to have a BMI of 20-30 kg/m2 and agree not to take vitamins or partake in strenuous activity during their involvement."

Answered by AI

Are there any vacancies currently available for participants in this trial?

"As per the data on clinicaltrials.gov, this research study is currently in need of participants. It was first posted to the website on March 5th 2021 and its last update occurred on March 23rd 2022."

Answered by AI

Does the trial include participants who have reached adulthood?

"This clinical trial has stipulated that eligible participants are aged between 18 and 60. There are separate trials for those younger than 18, as well as 81 specifically for seniors over 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dietary Oxalate and Innate Immunity in Kidney Stone Disease

Tanecia Mitchell, PhD 2021. "Dietary Oxalate and Innate Immunity in Kidney Stone Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04051346.

All > Kidney Stone