Trial Summary
What is the purpose of this trial?
This study will test whether oxalate stimulates urinary crystals and impacts the immune system in healthy subjects using two controlled diets (low and high oxalate).
Research Team
TM
Tanecia Mitchell, PhD
Principal Investigator
University of Alabama at Birmingham
Eligibility Criteria
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.Inclusion Criteria
Your body mass index (BMI) is between 20 and 30.
Willing to abstain from vigorous exercise and vitamins/supplements during the study
Your comprehensive metabolic panel (CMP) results are within the normal range.
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Exclusion Criteria
You use tobacco.
My doctor has advised against me joining this trial.
I have ongoing health issues.
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Treatment Details
Interventions
- High Oxalate Diet (Dietary Supplement)
- Low Oxalate Diet (Dietary Supplement)
Trial OverviewThe 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.
Participant Groups
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
Trials
1,677
Recruited
2,458,000+
Kierstin Kennedy
University of Alabama at Birmingham
Chief Medical Officer since 2022
MD
S. Dawn Bulgarella
University of Alabama at Birmingham
Chief Executive Officer since 2023
BSc in Commerce and Business Administration from the University of Alabama, MS in Health Administration from the University of Alabama at Birmingham