Dietary Oxalate and Innate Immunity in Kidney Stone Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Change in Monocyte Subtypes
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Monocyte Subtypes
时间窗: Days 1, 4, 11, and 14
Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).
Change in Crystalluria
时间窗: Days 3-4 and 13-14
Crystalluria will be reported as particles/ml.
Change in Monocyte Cellular Energetics and Mitochondrial Function
时间窗: Days 1, 4, 11, and 14
Cellular energetics and mitochondrial function will be reported as oxygen consumption rate (pmol/min/10,000 cells).
Change in Urinary Oxalate
时间窗: Days 3-4 and 13-14
Twenty-four hour urinary oxalate will be reported as mg/day.
Change in Monocyte Transcriptomics
时间窗: Days 1, 4, 11, and 14
Monocyte cellular transcriptomics will be determined using RNA sequencing (mRNA).
Urinary Oxalate Excretion
时间窗: Days 4 and 14
Twenty-four hour urinary oxalate will be reported as mg/day.
Crystalluria
时间窗: Day 4 and 14
Crystalluria will be reported as particles/ml.
Number of Participants With Monocyte Cellular Energetics
时间窗: Days 4 and 14
Cellular energetic oxygen consumption traces will be examined.
次要结局
- Number of Participants With Monocyte Transcriptomics(Days 4 and 14)
研究者
Tanecia Mitchell, PhD
Principal Investigator
University of Alabama at Birmingham