Dietary Oxalate and Innate Immunity in Kidney Stone Disease

N/AActive Not RecruitingNCT04051346

University of Alabama at Birmingham20 enrolled

Overview

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).

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 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

SINGLE

Enrollment

Conditions

Kidney Stone

Interventions

Low Oxalate DietDIETARY_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. Participants will be asked not to take any dietary supplements, to exercise strenuously, or to consume food or drink that is not provided to them

High Oxalate DietDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy subjects (men and women) between the ages of 18 and 60 years of age * No calcium oxalate kidney stones or other medical conditions * Normal comprehensive metabolic panel (CMP) * Non tobacco users * Not pregnant * BMI between 20-30 kg/m2 * Willing to abstain from vigorous exercise and vitamins/supplements during the study * Willing to consume only provided diets, accurately collect 24-hour urine samples, and have blood drawn Exclusion Criteria: * Inability to sign and read the informed consent * Any medical, psychiatric, or social conditions that would prohibit participants from abiding by the study requirements * Physician refusal * Pregnant women * Active medical problems * History of kidney stones or any medical condition that could influence absorption or excretion of oxalate * Tobacco users * Taking medications or dietary supplements * BMI \>30 or \<20

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Change in Urinary Oxalate

Twenty-four hour urinary oxalate will be reported as mg/day.

Time frame: Days 3-4 and 13-14

Change in Crystalluria

Crystalluria will be reported as particles/ml.

Time frame: Days 3-4 and 13-14

Change in Monocyte Cellular Energetics and Mitochondrial Function

Cellular energetics and mitochondrial function will be reported as oxygen consumption rate (pmol/min/10,000 cells).

Time frame: Days 1, 4, 11, and 14

Change in Monocyte Subtypes

Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).

Time frame: Days 1, 4, 11, and 14

Change in Monocyte Transcriptomics

Monocyte cellular transcriptomics will be determined using RNA sequencing (mRNA).

Time frame: Days 1, 4, 11, and 14

Data from ClinicalTrials.gov

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