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OpenTrials
Completed

NCT Number: NCT03808090

Obesity and Endogenous Oxalate Synthesis

The goal of this study is to determine if obesity is associated with increased endogenous oxalate synthesis as assessed by urinary oxalate excretion, which is a known risk factor for calcium oxalate kidney stones.

The study will recruit adult participants without history of kidney stones. Participants will

* Ingest fixed diets containing low amounts of oxalate for 4 days * Collect 24-hr urine samples during the fixed diet

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Key information

About this study

In this study the investigators propose to measure the excretion of urinary oxalate on a fixed diet with controlled amounts of oxalate, in individuals of varying body sizes without history of kidney stones. The 24-hr urinary oxalate excretion on such a low-oxalate normal calcium fixed diet is determined to be an appropriate surrogate for endogenous oxalate synthesis.

Screening phase. The study will enroll 60 individuals without history of kidney stones (30 males/30 females) at the University of Alabama at Birmingham (UAB).

Screening will include blood complete metabolic profile, 24-hr urine specimens collected at home on self-selected diets and anthropometric measurements.

Dietary phase Participants will ingest a low-oxalate (<60 mg/day), normal calcium (1000 mg/day) fixed diet for 4 consecutive days, collect three 24-hr urines after 1 day of dietary equilibration and have a fasted blood draw on day 5.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 19-70 yrs Body Mass Index > 18.5 kg/m2 Normal fasting serum electrolytes on comprehensive metabolic profile Willing to ingest fixed diets

Exclusion criteria

Chronic Kidney Disease, estimated glomerular filtration rate < 60 ml/mn/1.73m2 Primary hyperoxaluria Liver, endocrine or renal diseases or any other condition that may influence the absorption, transport or urinary excretion of ions, which will compromise the interpretation of results, including: Cystic fibrosis, Cystinuria, Uric acid stone former, Nephrotic syndrome, Sarcoidosis, Renal tubular acidosis, Primary hyperparathyroidism, Neurogenic bladder, Urinary diversion Pregnancy or breast-feeding Incompatible dietary requirements with the study, food allergies or intolerance to any of the foods in study menus Active malignancy or treatment for malignancy within 12 months prior to screening Utilization of immunosuppressive medication Uncontrolled Hypertension or diabetes

Treatment and study plan

Normal Individuals

Dietary Supplement

Controlled Dietary phase: Low oxalate fixed diet

4 days of fixed normal calorie diet with low oxalate (< 60 mg/day), normal calcium (800-1200 mg/day)

Primary outcomes

  1. Urinary Oxalate Excretion

    Time frame: 3 days on the fixed diet

    Mean Urinary oxalate excretion from three 24 hour urine collections on the fixed diet (mg/day)

Secondary outcomes

  1. Urinary Glycolate Excretion

    Time frame: 3 days on fixed diet

    mean of three 24-hr urinary glycolate collected on the fixed diet (mg/day)

  2. Urinary Creatinine Excretion

    Time frame: 3 days on the fixed diet

    mean of there 24hr urinary creatinine excretion on the fixed diet ( g/day)

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2013
Primary completion
2023
Study completion
2024
First posted
Jan 17, 2019
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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