MASLDNCT06735924
Influence of Metabolic Syndrome on Endogenous Oxalate Synthesis
A study testing Low-oxalate fixed diet in people with MASLD and Metabolic Dysfunction-Associated Steatotic Liver Disease, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study aims to determine the daily rate of endogenous synthesis of oxalate using fasted urine collection and a low-oxalate controlled diet in patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MASLD, Metabolic Dysfunction-Associated Steatotic Liver Disease
- What is being tested?
- Low-oxalate fixed diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >18 years
- History of MASLD, with liver fat content > 5%
- Normal kidney function
- Stable medication for at least 1 month for diabetes mellitus if any
- Willingess to ingest fixed diets and stop dietary supplements for the study and come to UAB for visits
Who cannot join
- Age < 18 years
- Inaccurate 24-hour urine collections
- Liver fat content <5%
- Liver cirrhosis
- Evidence of other chronic liver disease, viral hepatitis
- history of alcoholism within 2 years of enrollment
Show all 18Show fewer
- Contra-indication to Magnetic Resonance Imaging
- Chronic kidney disease with estimated Glomerular Filtration rate < 60 ml/min/1.73m2
- Type 1 Diabetes Mellitus or treatment with insulin
- Uncontrolled diabetes
- Pregnancy, lactation or intention to be
- Uncontrolled hypertension
- Use of weight loss medication, SGLT2 inhibitors, GLP-1 receptor agonists, osteoporosis medication, chronic NSAID
- History of gastric or intestinal surgery or resection that could potentially alter oxalate absorption
- Chronic fat malabsorption
- Use of immunosuppressive medications
- Known immuno-compromised status
- Active malignancy or treatment for malignanacy within the last 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Non Alcoholic Fatty Liver Disease and Endogenous Oxalate Synthesis
This study aims to determine the daily rate of endogenous synthesis of oxalate using fasted urine collection and a low-oxalate controlled diet in patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).
Read the detailed description
Urinary oxalate excretion is derived from both dietary sources and endogenous synthesis. This study will use a low-oxalate controlled diet, repeat fasted urine collections and 24-hr urine collections on a low-oxalate diet, to determine the daily rate of endogenous oxalate synthesis in individuals with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).
- Being tested
- Low-oxalate fixed diet
- Keywords
- oxalate synthesis, oxalate metabolism, MASLD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-oxalate fixed dietDietary supplement
Ingestion of a low-oxalate (< 60 mg/day) , normal calcium (800-1200 mg/d) eucaloric diet for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Estimation of endogenous oxalate production | Experimental | Fasted hourly urine collections after equilibration on a low-oxalate diet Receives: Dietary Supplement: Low-oxalate fixed diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
estimated endogenous oxalate synthesis rate
Average fasted hourly urinary oxalate excretion rate normalized to urinary creatinine excretion (mg oxalate / g urinary creatinine)
Measured: 1 day
Secondary outcomes (1)
Urinary Oxalate excretion
average urinary oxalate excretion rate normalized to urinary creatinine after equilibration on a low-oxalate fixed diet (mg urinary oxalate / g urinary creatinine)
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start26 Apr 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASLDStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyle D. Wood, University of Alabama at Birmingham
- Investigators
- Kyle D Wood, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735924
- Sponsor's protocol ID
- IRB300002318-FLO
- Other IDs
- 1R03DK139235-01, UAB
- Status last verified
- May 2026
- First submitted
- 11 Dec 2024
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Alcoholic Fatty Liver Disease and Endogenous Oxalate Synthesis
- ClinicalTrials.gov ID
- NCT06735924
- Acronym / sponsor ID
- IRB300002318-FLO
- Keywords
- oxalate synthesis, oxalate metabolism, MASLD
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine the daily rate of endogenous synthesis of oxalate using fasted urine collection and a low-oxalate controlled diet in patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).
Detailed description
Urinary oxalate excretion is derived from both dietary sources and endogenous synthesis. This study will use a low-oxalate controlled diet, repeat fasted urine collections and 24-hr urine collections on a low-oxalate diet, to determine the daily rate of endogenous oxalate synthesis in individuals with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Estimation of endogenous oxalate production | Experimental | Dietary Supplement: Low-oxalate fixed dietFasted hourly urine collections after equilibration on a low-oxalate diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age >18 years
- History of MASLD, with liver fat content > 5%
- Normal kidney function
- Stable medication for at least 1 month for diabetes mellitus if any
- Willingess to ingest fixed diets and stop dietary supplements for the study and come to UAB for visits
Key exclusion criteria (18 listed)
- Age < 18 years
- Inaccurate 24-hour urine collections
- Liver fat content <5%
- Liver cirrhosis
- Evidence of other chronic liver disease, viral hepatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-oxalate fixed dietIngestion of a low-oxalate (< 60 mg/day) , normal calcium (800-1200 mg/d) eucaloric diet for 5 days | Dietary supplement | Estimation of endogenous oxalate production |
Primary outcome
estimated endogenous oxalate synthesis rate
Time frame: 1 day
Average fasted hourly urinary oxalate excretion rate normalized to urinary creatinine excretion (mg oxalate / g urinary creatinine)
1 secondary outcome
Urinary Oxalate excretion
Time frame: 2 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyle D Wood, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-oxalate fixed diet in people with MASLD and Metabolic Dysfunction-Associated Steatotic Liver Disease, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
estimated endogenous oxalate synthesis rate (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.