Kidney Stone
Conditions
Keywords
dietary oxalate, diet therapy
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.
Interventions
DIETARY_SUPPLEMENTLow 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_SUPPLEMENTHigh 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.
Sponsors
University of Alabama at Birmingham
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary Oxalate Excretion | Days 4 and 14 | Twenty-four hour urinary oxalate will be reported as mg/day. |
| Crystalluria | Day 4 and 14 | Crystalluria will be reported as particles/ml. |
| Number of Participants With Monocyte Cellular Energetics | Days 4 and 14 | Cellular energetic oxygen consumption traces will be examined. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Monocyte Transcriptomics | Days 4 and 14 | Monocyte cellular transcriptomics will be determined using RNA sequencing (mRNA). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTanecia Mitchell, PhD
University of Alabama at Birmingham
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 41.3 years STANDARD_DEVIATION 13.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
None listed