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Dietary Supplement

Diet Impact on Kidney Stones in Obese Individuals

N/A
Waitlist Available
Led By Dean Assimos, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Permitted/willing to discontinue medications for kidney stone prevention, including thiazides, allopurinol, and febuxostat and citrate preparations, for 14 days before start and during the studies. They will be instructed to restart these medications at the conclusion of the study
24-hour urine collections with creatinine values within 20% of appropriate ratio of creatinine (mg)/body weight (kg) for gender, and with creatinine values that are consistent between collections (within 20% of each other)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through day 5
Awards & highlights

Study Summary

This trial will help researchers learn more about how different aspects of diet contribute to kidney stones in people of normal weight and in obese people.

Who is the study for?
This trial is for adults with normal (BMI ≥ 18.5 to < 25) or obese (BMI ≥ 30 to ≤ 45) who form calcium oxalate kidney stones, can consent, and follow a controlled diet without vigorous exercise. Excluded are those with diabetes, abnormal blood tests, certain kidney diseases, gastrointestinal disorders affecting oxalate transport, recent cancer treatment, pregnancy or breastfeeding women not using birth control.Check my eligibility
What is being tested?
The study investigates how obesity affects the body's processing of oxalate in people prone to calcium oxalate kidney stones. Participants will follow a controlled diet and ingest Carbon-13 Oxalate and Sucralose to track their metabolism and urinary excretion patterns.See study design
What are the potential side effects?
While the trial involves dietary changes rather than medication, potential side effects may include digestive discomfort due to new foods or supplements ingested during the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to stop my kidney stone prevention meds for the study duration.
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My kidney function tests are within the normal range for my gender and weight.
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I have had kidney stones made of calcium oxalate before.
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I am willing to stop taking supplements for 14 days before and during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through day 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through day 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Urinary Oxalate Excretion

Trial Design

1Treatment groups
Experimental Treatment
Group I: Controlled Dietary StudyExperimental Treatment2 Interventions
Participants will consume the controlled diet for five days. After one day on the diet, subjects will provide three 24-hour urine collections. On the last dayof the diet, subjects will come in a fasted state to ingest a small amount of carbon-13 oxalate and sucralose, with hourly urine collections and blood samples being taken before and after the ingestion.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,565 Previous Clinical Trials
2,268,336 Total Patients Enrolled
12 Trials studying Kidney Stones
693 Patients Enrolled for Kidney Stones
Dean Assimos, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
2 Previous Clinical Trials
80 Total Patients Enrolled
2 Trials studying Kidney Stones
80 Patients Enrolled for Kidney Stones

Media Library

Controlled Diet (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04333745 — N/A
Kidney Stones Research Study Groups: Controlled Dietary Study
Kidney Stones Clinical Trial 2023: Controlled Diet Highlights & Side Effects. Trial Name: NCT04333745 — N/A
Controlled Diet (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04333745 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research recruiting individuals aged 55 and older?

"In accordance with the trial's criteria, the minimum age of participants is 19 years old and cannot exceed 75."

Answered by AI

Are new participants currently being accepted for this research project?

"Patient recruitment for this medical study is ongoing, as indicated on clinicaltrials.gov. It was originally posted in September 2021 and has since seen a few updates the latest of which was filed on the 12th of that same month."

Answered by AI

What is the capacity of participants for this clinical experiment?

"Indeed, the information posted on clinicaltrials.gov demonstrates that this study is currently enrolling new participants; it was originally published on September 1st 2021 and last updated 12th of September 2022. A total of 64 patients are being recruited for two separate sites."

Answered by AI

To whom is this clinical investigation open?

"This medical trial is seeking 64 individuals with a history of kidney stones between the ages 19 and 75. Crucially, applicants must adhere to certain conditions: abstain from consuming supplements for two weeks before and during study; consume meals according to diet guidelines; provide 24-hour urine samples that meet creatinine values associated with body weight and gender (within 20% variation); maintain BMI in normal range (18.5 - 25) or obese range (30 - 45)."

Answered by AI
~5 spots leftby Dec 2024