The Interplay Between Oxalate, Immunity and Infection | NCT04605055

NCT04605055

Protocol Section

Identification Module

Results Section

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No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low Oxalate Diet Followed by High Oxalate Diet	Experimental	Subjects will consume a low oxalate diet for four days, with blood collections on Days 1 and 4 and 24-hour urine collections on Days 3 and 4. A ten day wash out period will follow, during which participants will consume their normal diet. After the wash out period, subjects will consume a high oxalate diet for four days, with blood and 24-hour urine collections occurring again as described previously.	Dietary Supplement: Low Oxalate Diet Dietary Supplement: High Oxalate Diet
High Oxalate Diet Followed by Low Oxalate Diet	Experimental	Subjects will consume a high oxalate diet for four days, with blood collections on Days 1 and 4 and 24-hour urine collections on Days 3 and 4. A ten day wash out period will follow, during which participants will consume their normal diet. After the wash out period, subjects will consume a low oxalate diet for four days, with blood and 24-hour urine collections occurring again as described previously.	Dietary Supplement: Low Oxalate Diet Dietary Supplement: High Oxalate Diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Low Oxalate Diet	Dietary Supplement	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Urinary Oxalate	Twenty-four hour urinary oxalate will be reported as mg/day	Change between Baseline and Diets at 4 days
Crystalluria	Twenty-four hour crystalluria will be reported as particles/ml	Change between Baseline and Diets at 4 days
Monocyte Cellular Bioenergetics	Cellular bioenergetics will be reported as oxygen consumption rate	Change between Baseline and Diets at 4 days
Monocyte Mitochondrial Complex Activity	Monocyte mitochondrial complex activity will be reported as oxygen consumption rate	Change between Baseline and Diets at 4 days
Monocyte Transcriptomics	Monocyte transcriptomics will be reported as gene expression (mRNA levels)	Change between Baseline and Diets at 4 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Able to provide informed consent
Body Mass Index (BMI) between 20-30 kg/m2
Non tobacco users or not pregnant/breast feeding/nursing
Normal fasting blood comprehensive metabolic panel, complete blood count, C-reactive protein, and urinalysis. Must accurately collect two 24-hour urine collections within 20% of appropriate ratio of creatinine (mg)/body weight (kg) for gender
Healthy subjects: No history of calcium oxalate kidney stones (CaOx KS) or other medical conditions
Patients with CaOx KS: Recent stone composition greater than 50% CaOx; no uric acid or struvite stone content must be present. Must be first time or recurrent CaOx stone former (last stone event within the past 3 years)
Willing to not consume supplements (i.e. vitamins, Ca (citrate or carbonate) and other minerals, herbal supplements, nutritional aids, and probiotics) for 2 weeks before the study and during the study
Willing to abstain from vigorous exercise during the study as this may compromise immune function.
Willing to consume diets provided only by the University of Alabama Center for Clinical and Translational Science Bionutrition Core. No food allergies or intolerance to any of the foods on the study menus.
Willing to accurately collect 24-hour urine samples, and to have blood drawn throughout the study.
If on medications for kidney stone prevention (e.g. thiazides, citrate supplementation excluding calcium citrate), patients must be on a stable dose regimen for at least 8 weeks prior to and during screening, with no changes in dosing anticipated during the study. Patients should not take allopurinol for 2 weeks prior to screening since allopurinol has anti-oxidant properties.

Exclusion Criteria:

Failure to meet the inclusion criteria or physician refusal
Inability to sign and read the informed consent
Any medical, psychiatric, or social conditions that would prohibit participants from abiding to the study requirements
BMI greater than 30 kg/m2 or less than 20 kg/m2
Tobacco users or pregnant or breast feeding/nursing women
Abnormal fasting blood comprehensive metabolic panel, complete blood count, C-reactive protein, and urinalysis. Inaccurate 24-hour urine collections.
Healthy subjects: Taking medications or dietary supplements. History of kidney stones or any medical condition that could influence absorption or excretion of oxalate.
Active illness including COVID-19, flu, common cold, fever, diarrhea, urinary tract infections or other infections 14 days before the study and throughout the study.
Active disease including diabetes, gout, hypertension, primary hyperoxaluria, nephrotic syndrome, enteric hyperoxaluria, renal tubular acidosis, primary hyperparathyroidism, liver disease, autoimmune disorder, neurogenic bladder, urinary diversion, and bariatric surgery.
Active malignancy or treatment for malignancy within 12 months prior to screening.

ID	Term
D053040	Nephrolithiasis
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases