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Low-Oxalate Diet for Fatty Liver Disease
N/A
Recruiting
Led By Kyle D Wood, 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
History of MASLD, with liver fat content > 5%
Normal kidney function
Must not have
Liver cirrhosis
Evidence of other chronic liver disease, viral hepatitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 days
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to find out how much oxalate the body makes naturally each day in patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) by collecting urine samples after fasting
Who is the study for?
This trial is for individuals with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), commonly known as fatty liver disease. Participants should be able to follow a controlled diet and provide urine samples.
What is being tested?
The study is testing how a low-oxalate fixed diet affects the body's natural production of oxalate in patients with MASLD by analyzing fasted urine samples.
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects may include digestive discomfort or food cravings due to the restricted nature of the low-oxalate diet.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a liver disease with more than 5% fat content.
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My kidney function is normal.
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I am older than 18 years.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have liver cirrhosis.
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I have a chronic liver condition or viral hepatitis.
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I am under 18 years old.
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My kidney function is reduced with a filtration rate below 60 ml/min.
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I have Type 1 Diabetes or I am treated with insulin.
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My blood pressure is not well-controlled.
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I am currently taking medications that suppress my immune system.
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I have not had cancer or cancer treatment in the past year.
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My diabetes is not under control.
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I have long-term issues absorbing fats.
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I have a weakened immune system.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
estimated endogenous oxalate synthesis rate
Secondary study objectives
Urinary Oxalate excretion
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Estimation of endogenous oxalate productionExperimental Treatment1 Intervention
Fasted hourly urine collections after equilibration on a low-oxalate diet
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,656 Previous Clinical Trials
2,444,345 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,464 Previous Clinical Trials
4,337,425 Total Patients Enrolled
1 Trials studying Fatty Liver Disease
144 Patients Enrolled for Fatty Liver Disease
Kyle D Wood, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
58 Total Patients Enrolled