Dietary Oxalate and Innate Immunity in Kidney Stone Disease

Kidney Stone Clinical Trial

Official title:

Dietary Oxalate and Innate Immunity in Kidney Stone Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04051346
• Other study ID #: IRB-300003865
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 5, 2021
• Est. completion date: May 1, 2025

Study information

• Verified date: May 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone
• Nephrolithiasis

Intervention

Dietary Supplement:
• Low Oxalate Diet
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 Diet
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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Urinary Oxalate	Twenty-four hour urinary oxalate will be reported as mg/day.	Days 3-4 and 13-14
Primary	Change in Crystalluria	Crystalluria will be reported as particles/ml.	Days 3-4 and 13-14
Primary	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).	Days 1, 4, 11, and 14
Primary	Change in Monocyte Subtypes	Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).	Days 1, 4, 11, and 14
Primary	Change in Monocyte Transcriptomics	Monocyte cellular transcriptomics will be determined using RNA sequencing (mRNA).	Days 1, 4, 11, and 14