Back to resultsDietary Oxalate and Innate Immunity in Kidney Stone Disease
Primary Purpose
Kidney Stone
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Oxalate Diet
High Oxalate Diet
Sponsored by
About this trial
This is an interventional basic science trial for Kidney Stone focused on measuring dietary oxalate, diet therapy
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
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Low Oxalate Diet Followed by High Oxalate Diet
High Oxalate Diet Followed by Low Oxalate Diet
Arm 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 ten day wash out period will follow, during which the subject will consume a self-selected 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.
Subjects will consume a high oxalate diet for four days, with blood and 24-hour urine collections occurring at baseline and post diet. A ten day wash out period will follow, during which the subject will consume a self-selected 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.
Outcomes
Primary Outcome Measures
Change in Urinary Oxalate
Twenty-four hour urinary oxalate will be reported as mg/day.
Change in Crystalluria
Crystalluria will be reported as particles/ml.
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).
Change in Monocyte Subtypes
Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).
Change in Monocyte Transcriptomics
Monocyte cellular transcriptomics will be determined using RNA sequencing (mRNA).
Secondary Outcome Measures
Full Information
NCT ID
NCT04051346
First Posted
August 1, 2019
Last Updated
October 10, 2023
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT04051346
Brief Title
Dietary Oxalate and Innate Immunity in Kidney Stone Disease
Official Title
Dietary Oxalate and Innate Immunity in Kidney Stone Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 5, 2021 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone
Keywords
dietary oxalate, diet therapy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low Oxalate Diet Followed by High Oxalate Diet
Arm Type
Experimental
Arm 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 ten day wash out period will follow, during which the subject will consume a self-selected 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 Title
High Oxalate Diet Followed by Low Oxalate Diet
Arm Type
Experimental
Arm 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 ten day wash out period will follow, during which the subject will consume a self-selected 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Low Oxalate Diet
Intervention 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(s)
High Oxalate Diet
Intervention 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.
Primary Outcome Measure Information:
Title
Change in Urinary Oxalate
Description
Twenty-four hour urinary oxalate will be reported as mg/day.
Time Frame
Days 3-4 and 13-14
Title
Change in Crystalluria
Description
Crystalluria will be reported as particles/ml.
Time Frame
Days 3-4 and 13-14
Title
Change in Monocyte Cellular Energetics and Mitochondrial Function
Description
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
Title
Change in Monocyte Subtypes
Description
Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).
Time Frame
Days 1, 4, 11, and 14
Title
Change in Monocyte Transcriptomics
Description
Monocyte cellular transcriptomics will be determined using RNA sequencing (mRNA).
Time Frame
Days 1, 4, 11, and 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanecia Mitchell, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dietary Oxalate and Innate Immunity in Kidney Stone Disease
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