This study is looking to understand the role of oxalate on kidney stone development and immunity. This study will enroll healthy participants and participants with calcium oxalate kidney stones (CaOx KS). Participants will be in this study for about 3 weeks, consume controlled diets, and provide blood and urine specimens.
The purpose of this longitudinal study is to examine the effects of dietary oxalate on nanocrystalluria and the immune system. Oxalate is a small molecule found in plants and plant-derived food. It has been shown that meals containing high amounts of oxalate can increase urinary oxalate excretion, which is a risk factor for calcium oxalate kidney stones (CaOx KS). Small increases in oxalate can stimulate urinary crystals to form which can elicit an immune response. This study consists of having healthy subjects and patients with CaOx KS consume both low and oxalate enriched diets to evaluate the effect of oxalate on urinary crystals and immune responses. Participants will receive a low or high oxalate diet for 4 days prior to having a wash-out period for 6 days. Participants will then crossover to the opposite oxalate diet for four more days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
88
Participants will consume a diet that is controlled in its daily contents of oxalate and calcium, and in its content of carbohydrate, fat, and protein. Participants will be asked not to take any dietary supplements, exercise strenuously, or consume food or drink that is not provided to them.
Participants will consume a diet that is controlled in its daily contents of oxalate and calcium, and in its content of carbohydrate, fat, and protein. Participants will be asked not to take any dietary supplements, exercise strenuously, or consume food or drink that is not provided to them.
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGChange in Urinary Oxalate
Twenty-four hour urinary oxalate will be reported as mg/day.
Time frame: Days 3-4 and 13-14
Change in Nanocystalluria
Nanocrystalluria will be reported as particles/ml.
Time frame: Days 3-4 and 13-14
Monocyte Cellular Bioenergetics and Mitochondrial Function
Cellular bioenergetics and mitochondrial function will be reported as oxygen consumption rate (pmol/min/10,000 cells).
Time frame: Day 1
Monocyte Cellular Bioenergetics and Mitochondrial Function
Cellular bioenergetics and mitochondrial function will be reported as oxygen consumption rate (pmol/min/10,000 cells).
Time frame: Day 4
Monocyte Cellular Bioenergetics and Mitochondrial Function
Cellular bioenergetics and mitochondrial function will be reported as oxygen consumption rate (pmol/min/10,000 cells).
Time frame: Day 11
Monocyte Cellular Bioenergetics and Mitochondrial Function
Cellular bioenergetics and mitochondrial function will be reported as oxygen consumption rate (pmol/min/10,000 cells).
Time frame: Day 14
Monocyte Subtypes
Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).
Time frame: Day 1
Monocyte Subtypes
Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).
Time frame: Day 4
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Monocyte Subtypes
Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).
Time frame: Day 11
Monocyte Subtypes
Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).
Time frame: Day 14
Monocyte Transcriptomics
Monocyte transcriptomics will be reported as gene expression (mRNA levels)
Time frame: Day 1
Monocyte Transcriptomics
Monocyte transcriptomics will be reported as gene expression (mRNA levels)
Time frame: Day 4
Monocyte Transcriptomics
Monocyte transcriptomics will be reported as gene expression (mRNA levels)
Time frame: Day 11
Monocyte Transcriptomics
Monocyte transcriptomics will be reported as gene expression (mRNA levels)
Time frame: Day 14