Low-Oxalate Diet for Fatty Liver Disease

Overseen By Sonia Fargue, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Weight loss, SGLT2 inhibitors

Disqualifiers: Liver cirrhosis, Type 1 diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

28 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must have stable medication for diabetes for at least 1 month. You will need to stop dietary supplements for the study.

How does the low-oxalate diet treatment for fatty liver disease differ from other treatments?

The low-oxalate diet is unique because it focuses on reducing oxalate intake, which is not a common approach in existing treatments for fatty liver disease. Other treatments often emphasize weight loss, low-carbohydrate diets, or Mediterranean diets rich in unsaturated fats and fiber. ^{1 2 3 4 5}

What is the purpose of this trial?

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).

Research Team

Kyle D Wood, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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.

Inclusion Criteria

Willingness to ingest fixed diets and stop dietary supplements for the study and come to UAB for visits

I have a liver disease with more than 5% fat content.

My kidney function is normal.

Exclusion Criteria

History of alcoholism within 2 years of enrollment

Pregnancy, lactation or intention to be

Inaccurate 24-hour urine collections

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Diet Equilibration

Participants are placed on a low-oxalate controlled diet to equilibrate before urine collection

1 week

Urine Collection

Fasted hourly urine collections and 24-hour urine collections are conducted to measure oxalate synthesis

3 days

Daily visits for urine collection

Follow-up

Participants are monitored for any adverse effects and data analysis is conducted

1 week

Treatment Details

Interventions

• Low-oxalate fixed diet

Trial Overview 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.

Participant Groups

Group I: Estimation of endogenous oxalate production Experimental Treatment 1 Intervention

Fasted hourly urine collections after equilibration on a low-oxalate diet

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

In a study of 36 patients with a BMI over 30 kg/m2, both a formula diet with oat fibers and a low glycemic diet led to significant weight loss and improvements in liver function after 12 weeks.

The formula diet was more effective than the control diet in reducing intrahepatic lipid content and lowering blood pressure, indicating its potential as a superior dietary intervention for managing non-alcoholic fatty liver disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparison of a commercially available, formula-based nutritional therapy enriched with oats fiber with a non-formula isocaloric therapy to treat non-alcoholic fatty liver disease (NAFLD) - a randomized, controlled intervention trial]. Schweinlin, A., Ulbrich, S., Stauß, S., et al.[2019]

A clinical randomized controlled trial involving Chinese participants with nonalcoholic fatty liver disease showed that a freshwater fish-based diet significantly alleviated liver steatosis, indicating its potential as a dietary intervention for this condition.

The study suggests that the beneficial effects of the fish-based diet may be linked to changes in gut microbiota and metabolites, highlighting the importance of diet in managing liver health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In nonalcoholic fatty liver disease, a diet of freshwater fish vs. freshwater fish plus red meat reduced liver fat. Mukherjee, S.[2023]

A systematic review of three trials involving 128 adults with non-alcoholic fatty liver disease (NAFLD) found that specific dietary patterns, particularly the Mediterranean diet, can significantly reduce hepatic fat content and triglyceride levels.

The Mediterranean diet showed strong evidence of reducing hepatic fat by 4.1% and triglycerides by 16.9 mg/dL compared to low-fat diets, highlighting its potential as an effective lifestyle modification for managing NAFLD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of dietary patterns on non-alcoholic fatty liver disease diagnosed by biopsy or magnetic resonance in adults: a systematic review of randomised controlled trials. Angelidi, AM., Papadaki, A., Nolen-Doerr, E., et al.[2022]

A 12-week study involving 88 Chinese females with nonalcoholic fatty liver disease (NAFLD) showed that a Mediterranean-like diet led to significant weight loss and reductions in liver fat content, with the diet group losing an average of 4.0 kg compared to only 1.5 kg in the control group.

Supplementation with pentadecanoic acid (C15:0) further improved health outcomes by lowering LDL-cholesterol and positively affecting gut microbiome composition, indicating that this dietary approach can enhance metabolic health in individuals with NAFLD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of an Asian-adapted Mediterranean diet and pentadecanoic acid on fatty liver disease: The TANGO randomized controlled trial. Chooi, YC., Zhang, QA., Magkos, F., et al.[2023]

In a pilot study of 5 patients with obesity-related fatty liver disease, a low-carbohydrate ketogenic diet for 6 months resulted in an average weight loss of 12.8 kg, indicating its potential effectiveness for weight management.

Post-treatment liver biopsies showed significant histological improvements in liver fat content, inflammation, and fibrosis, suggesting that this dietary approach may help reverse fatty liver disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a low-carbohydrate, ketogenic diet on nonalcoholic fatty liver disease: a pilot study. Tendler, D., Lin, S., Yancy, WS., et al.[2018]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Comparison of a commercially available, formula-based nutritional therapy enriched with oats fiber with a non-formula isocaloric therapy to treat non-alcoholic fatty liver disease (NAFLD) - a randomized, controlled intervention trial]. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

In nonalcoholic fatty liver disease, a diet of freshwater fish vs. freshwater fish plus red meat reduced liver fat. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

The effect of dietary patterns on non-alcoholic fatty liver disease diagnosed by biopsy or magnetic resonance in adults: a systematic review of randomised controlled trials. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of an Asian-adapted Mediterranean diet and pentadecanoic acid on fatty liver disease: The TANGO randomized controlled trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The effect of a low-carbohydrate, ketogenic diet on nonalcoholic fatty liver disease: a pilot study. [2018]