Purpose

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).

Condition

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Low Oxalate Diet Followed by High Oxalate Diet
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.
  • 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
  • Dietary Supplement: 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.
Experimental
High Oxalate Diet Followed by Low Oxalate 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 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.
  • 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
  • Dietary Supplement: 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.

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233
Contact:
Tanecia Mitchell, PhD
205-996-2292
taneciamitchell@uabmc.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Tanecia Mitchell, PhD
205-996-2292
taneciamitchell@uabmc.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.