Low-Oxalate Diet for Fatty Liver Disease
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alabama at Birmingham
Must not be taking: Weight loss, SGLT2 inhibitors
Disqualifiers: Liver cirrhosis, Type 1 diabetes, others
No Placebo Group
Trial Summary
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).
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.
12345Eligibility 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.
+2 more
Exclusion Criteria
History of alcoholism within 2 years of enrollment
Pregnancy, lactation or intention to be
Inaccurate 24-hour urine collections
+15 more
Trial 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
Participant Groups
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.
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 Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Alabama at BirminghamBirmingham, AL
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Who Is Running the Clinical Trial?
University of Alabama at BirminghamLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
[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]Non-alcoholic fatty liver disease (NAFLD) is mainly treated with caloric restriction and consecutive weight reduction. Protein, in exchange for starch and sugar as well as monounsaturated and long chain omega-3-fatty acids and prebiotic β-glucan, are thought to be supportive.In a randomized controlled intervention study, two different dietary concepts were tested regarding effects on intrahepatic lipid content as well as on biochemical parameters in patients with a body-mass-index (BMI) > 30 kg/m2 and signs of fatty liver disease. The intervention group (IG, n = 17) received a commercially available formula diet supplemented with oats fibers. The control group (CG, n = 19) received a comparably restricted diet (approx. 1000 kcal/d) according to the "low glycemic and insulinemic diet" method.After twelve weeks, both interventions resulted into a reduction of BMI (IG: 33.8 ± 2.9 to 29.3 ± 2.5 kg/m2, CG: 33.7 ± 2.8 to 30.1 ± 3.2 kg/m2, both p < 0.001), as well as an improvement of liver and other metabolic functions. The hepatorenal index decreased in both groups, however, this reduction was more pronounced in the IG than in the CG (end of the study: 1.1 ± 0.2 vs. 1.9 ± 0.3, p < 0.05). A reduction of blood pressure only occurred in the IG (systolic from 136 ± 15 mmHg to 122 ± 11 mmHg, diastolic from 89 ± 9 mmHg to 79 ± 11 mmHg, both p < 0.01).In conclusion, we found that both dietetic interventions were similarly effective regarding weight reduction, but the formula diet with oats fibers was more effective regarding the reduction of intrahepatic lipid content and blood pressure than the control diet.
In nonalcoholic fatty liver disease, a diet of freshwater fish vs. freshwater fish plus red meat reduced liver fat. [2023]Label="SOURCE CITATION">He K, Guo LL, Tang H, et al. A freshwater fish-based diet alleviates liver steatosis by modulating gut microbiota and metabolites: a clinical randomized controlled trial in Chinese participants with nonalcoholic fatty liver disease. Am J Gastroenterol. 2022;117:1621-3135973188.
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]Adhering to specific dietary patterns might hold promise as a lifestyle modification treatment of non-alcoholic fatty liver disease (NAFLD). The aim of this systematic review was to examine the effect of dietary patterns on changes in hepatic fat content, liver enzymes and metabolic syndrome components. We searched Pubmed, Embase, CINAHL and Web of Science for randomised controlled trials published in English until April 2020, comparing a specific dietary pattern with no treatment, usual care, or a different diet in adults with NAFLD. Studies were included if NAFLD had been diagnosed using biopsy, magnetic resonance imaging, or proton magnetic resonance spectroscopy. Data from three trials in adults with NAFLD but without diabetes (n = 128; mean age 49.9 ± 5.0 years, range 42-55 years) were included in the qualitative synthesis; across them, risk of bias was considered low, unclear and high for 33%, 38% and 29% of domains, respectively. There was moderate evidence that a low-carbohydrate, compared to a low-calorie diet (-27%, P = 0.008, one study, n = 18) and the Mediterranean, compared to a low-fat, high-carbohydrate diet (-4.4%, P = 0.030, one study, n = 12) result in greater reductions in hepatic fat content, but no such evidence was found for the Fatty Liver in Obesity dietary pattern (based on the principles of the Mediterranean diet), compared to the American Heart Association diet (-0.6%, P = 0.706, one study, n = 98). No between-group differences were reported for other outcomes across studies. A post hoc analysis, including two eligible studies assessing the effect of the Mediterranean, compared to a low-fat diet, irrespective of baseline presence of diabetes, showed strong evidence that the Mediterranean diet reduces hepatic fat content (-4.1%, 95% CI = -5.8 to -2.3, P < 0.001; I2 = 0%) and triglyceride concentrations (-16.9 mg/dL, 95% CI = -26.3 to -7.7, P < 0.001; I2 = 0%). Well-designed, adequately powered and rigorous randomised controlled trials are needed to provide robust evidence on the effect of these dietary patterns, but also other whole dietary approaches, on NAFLD progression.
Effect of an Asian-adapted Mediterranean diet and pentadecanoic acid on fatty liver disease: The TANGO randomized controlled trial. [2023]Weight loss is the most effective treatment for non-alcoholic fatty liver disease (NAFLD). There is evidence that Mediterranean diets rich in unsaturated fatty acids and fiber have beneficial effects on weight homeostasis and metabolic risk factors in individuals with NAFLD. Studies have also shown that higher circulating concentrations of pentadecanoic acid (C15:0) are associated with lower risk for NAFLD.
The effect of a low-carbohydrate, ketogenic diet on nonalcoholic fatty liver disease: a pilot study. [2018]Nonalcoholic fatty liver disease is an increasingly common condition that may progress to hepatic cirrhosis. This pilot study evaluated the effects of a low-carbohydrate, ketogenic diet on obesity-associated fatty liver disease. Five patients with a mean body mass index of 36.4 kg/m(2) and biopsy evidence of fatty liver disease were instructed to follow the diet (