Dietary Oxalate and Innate Immunity in Kidney Stone Disease

Dietary Oxalate and Innate Immunity in Kidney Stone Disease

Sponsors

Lead sponsor: University of Alabama at Birmingham

Source University of Alabama at Birmingham
Brief 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).

Detailed 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.

Overall Status Recruiting
Start Date May 1, 2020
Completion Date March 1, 2024
Primary Completion Date March 1, 2023
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Urinary Oxalate Days 2-3 and 12-13
Change in Crystalluria Days 2-3 and 12-13
Change in Monocyte Cellular Energetics and Mitochondrial Function Days 1, 4, 11, and 14
Change in Monocyte Subtypes Days 1, 4, 11, and 14
Change in Monocyte Transcriptomics Days 1, 4, 11, and 14
Enrollment 20
Condition
Intervention

Intervention type: Dietary Supplement

Intervention name: Low Oxalate Diet

Description: 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

Intervention type: Dietary Supplement

Intervention name: High Oxalate Diet

Description: 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.

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: 60 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Tanecia Mitchell, PhD Principal Investigator University of Alabama at Birmingham
Overall Contact

Last name: Tanecia Mitchell, PhD

Phone: 205-996-2292

Email: [email protected]

Location
facility status contact University of Alabama at Birmingham Tanecia Mitchell, PhD 205-996-2292 [email protected]
Location Countries

United States

Verification Date

March 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of Alabama at Birmingham

Investigator full name: Tanecia Mitchell, PhD

Investigator title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Low Oxalate Diet Followed by High Oxalate Diet

Arm group type: Experimental

Description: Subjects will consume a low oxalate diet for four days, with blood and 24-hour urine collections occurring at baseline and post diet. A six day wash out period will follow, during which the subject will consume the low oxalate diet. Subjects will then consume the high oxalate diet for the final four days, with blood and 24-hour urine collections once again occurring at baseline and post diet.

Arm group label: High Oxalate Diet Followed by Low Oxalate Diet

Arm group type: Experimental

Description: Subjects will consume a high oxalate diet for four days, with blood and 24-hour urine collections occurring at baseline and post diet. A six day wash out period will follow, during which the subject will consume the low oxalate diet. Subjects will then consume the low oxalate diet for the final four days, with blood and 24-hour urine collections once again occurring at baseline and post diet.

Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Treatment

Masking: Single (Participant)

Source: ClinicalTrials.gov