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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a low-oxalate diet affects oxalate production in individuals with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), a condition characterized by fat accumulation in the liver. The researchers aim to understand oxalate production, a compound that can lead to kidney stones, by analyzing urine samples from participants. It is ideal for those diagnosed with MASLD, having more than 5% liver fat, normal kidney function, and willing to eat specific meals and discontinue dietary supplements during the study. As an unphased trial, this study provides a unique opportunity to enhance scientific understanding of diet's impact on liver health.

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.

What prior data suggests that this low-oxalate diet is safe for patients with MASLD?

Research shows that a low-oxalate diet is generally easy for most people to follow. Studies have found that these diets can alter the amount of oxalate in urine and may help lower the risk of kidney stones. Although specific information on side effects from low-oxalate diets is not available in the sources, such dietary changes are usually safe for most people.

This trial is in a "Not Applicable" phase, indicating minimal risk. These trials typically focus on diet changes rather than new drugs, which often present fewer safety concerns. It is important to consult a healthcare professional before making any dietary changes, especially if existing health conditions are present. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of a low-oxalate diet as a way to manage fatty liver disease. Unlike typical treatments that may rely on medication to reduce liver fat or inflammation, this approach focuses on dietary intervention. By understanding how a low-oxalate diet affects oxalate production in the body, researchers hope to uncover a new, natural method to help manage fatty liver disease. This trial could lead to a simple yet effective dietary strategy that provides an alternative to existing pharmaceutical treatments.

What evidence suggests that a low-oxalate diet is effective for fatty liver disease?

Research has shown that reducing oxalate production in the liver can decrease fat buildup in liver cells. High oxalate levels hinder the liver's ability to break down fats properly. One study found that controlling oxalate levels improved liver health by aiding fat breakdown. Another study suggested that a low-oxalate diet could also reduce liver fat. This trial will evaluate the effects of a low-oxalate diet on liver health for people with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), building on these findings. ^{6 7 8 9 10}

Who Is on the Research Team?

Kyle D Wood, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

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(PDF) Inhibition of hepatic oxalate overproduction ... In turn, oxalate promotes steatosis in hepatocytes by inhibiting peroxisome proliferator-activated receptor-α (PPARα) transcription and fatty ...

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Metabolic dysfunction-associated fatty liver disease and ... This study found a significant positive association between MAFLD and nephrolithiasis. The risk of nephrolithiasis in males with MAFLD increased substantially.

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Inhibition of hepatic oxalate overproduction ameliorates ... Nitro-fatty acids protect against steatosis and fibrosis during development of nonalcoholic fatty liver disease in mice. eBioMedicine41, 62–72 (2019). [DOI] ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8575151/

Is It Time to Retire the Low-Oxalate Diet? No! - PMC The available evidence indicates that dietary intake of oxalate, calcium, and ascorbic acid have strong associations with urinary oxalate and kidney stone risk.

8. mdpi.com mdpi.com/2072-6643/16/7/1030

Effect of a Low-Calorie Dietary Intervention on Liver Health ... This review assessed the efficacy of a Low-Calorie Diet (LCD) on liver health and body weight in people living with MASLD and obesity. Methods: ...

9. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2022.987921/full

Low fat diet versus low carbohydrate diet for management ... Ad libitum mediterranean and low-fat diets both significantly reduce hepatic steatosis: a randomized controlled trial. Hepatology. (2018) 68 ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3732059/

Implications of Diet on Nonalcoholic Fatty Liver Disease - PMC This review examines the effects of diet on nonalcoholic fatty liver disease (NAFLD). This includes the effects of calories, both in excess and restricted, as ...