Very Low Calorie Diet for Non-alcoholic 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 Iowa
Must not be taking: Insulin, Warfarin, Lithium, Prednisone
Disqualifiers: Type 1 diabetes, Heart failure, Chronic kidney disease, Severe mental health disease, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Non-alcoholic fatty liver disease (NAFLD) is a common complication of obesity which can progress to deadly complications like end-stage liver disease and hepatocellular carcinoma. In the wake of the obesity epidemic, NAFLD is becoming the main etiology of liver transplantation in the US. Currently, there are no FDA approved pharmacological treatments for NAFLD. Weight loss through lifestyle modifications, pharmacotherapy and bariatric surgery can be effective strategies for the management of NAFLD. Even though substantial weight loss and improvement in NAFLD can be achieved with bariatric surgery, only a small proportion of patients with obesity undergo surgery. Very-low calorie diets (VLCD) are replacement meals manufactured to substitute natural foods and limited total intake of 800-960 kcal in divided meals. Very low-calorie diets can produce substantial weight loss of 10% over 2 to 3 months. We hypothesize that VLCD reduce liver steatosis and, fibrosis measured non-invasively with transient elastography. Our main aim is #1 to assess the effect of VLCD on liver fatty infiltration and fibrosis. We also have three exploratory aims exploring novel pathogenic factors that mediate the improvement of NAFLD by VLCD: #2 assess the effect of VLCD on micro RNAs (miRs) associated with pathophysiology of NAFLD: #3 assess the effect of VLCD on changes of salivary and fecal microbiome in the setting of NAFLD: #4 to determine the effect of VLCD on platelet function. This pilot project will produce preliminary data for the development of a larger grant application to study the efficacy of VLCD in the management of NAFLD. Furthermore, it will potentially identify factors that mediate improvement of NAFLD after VLCD. We will treat 10 subjects with obesity and NAFLD for 8 weeks with VLCD or lower calorie diet (control group) and obtain transient elastography before and after the interventions along with other measurements of interest. Our project may have significant impact by establishing VLCD as a clinically effective option for the improvement of liver steatosis and fibrosis in patients with obesity and NAFLD ineligible or without access to bariatric surgery.
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 cannot participate if you use insulin for type 2 diabetes or take warfarin, lithium, or chronic prednisone (20mg or more daily).
What data supports the effectiveness of the treatment Very low calorie diet (VLCD) for Non-alcoholic Fatty Liver Disease?
Research shows that a very low calorie diet (VLCD) can help people with non-alcoholic fatty liver disease (NAFLD) lose weight and improve liver health. Studies found that VLCDs can lead to significant weight loss and improvements in liver function, making it a promising option for managing NAFLD.
12345Is a very low calorie diet safe for humans?
Very low calorie diets (VLCDs) are generally safe for humans, but they can cause mild side effects. In studies, most people tolerated the diet well, though a few stopped due to adverse effects. It's important to monitor for potential issues like gallstones when following a VLCD.
12367How does a very low calorie diet (VLCD) differ from other treatments for non-alcoholic fatty liver disease (NAFLD)?
A very low calorie diet (VLCD) is unique because it focuses on achieving significant weight loss, which is crucial for improving non-alcoholic fatty liver disease (NAFLD). Unlike standard dietary approaches, VLCDs can help patients reach the recommended weight loss goal of 10% or more, leading to improvements in liver health and function.
12348Eligibility Criteria
This trial is for adults aged 18-70 with obesity (BMI between 30 and 50) and non-alcoholic fatty liver disease, confirmed by imaging or specific elastography scores. Participants must not have viral hepatitis, autoimmune hepatitis, uncontrolled thyroid issues, severe alcohol use, certain heart conditions, type 1 diabetes or insulin-using type 2 diabetes, significant kidney disease or other serious health problems.Inclusion Criteria
My BMI is between 30 and 50.
I have signs of fatty liver on an ultrasound, CT scan, MRI, or my elastography score is F1 or higher/S1 or higher.
Negative tests for viral hepatitis C (hepatitis C antibody) and autoimmune hepatitis (anti-smooth muscle antibody)
+1 more
Exclusion Criteria
I have porphyria.
Subjects with no elastography in the previous 12 months will be excluded from the study
I have had a heart attack in the last 6 months.
+17 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Treatment
Participants receive a Very Low-Calorie Diet (VLCD) intervention for 8 weeks to assess its effect on liver steatosis and fibrosis
8 weeks
4 visits (in-person) at weeks 0, 2, 4, and 8; weekly telephone or video-call contacts
Follow-up
Participants are monitored for adherence to a low calorie, low fat diet and weight trajectory after the VLCD intervention
4 weeks
Weekly telephone or video-call contacts
Participant Groups
The study tests if a very low calorie diet (VLCD), which limits intake to about 800-960 calories per day through meal replacements, can reduce fat and fibrosis in the liver compared to a lower calorie diet. The effects on micro RNAs related to NAFLD pathophysiology will also be explored.
2Treatment groups
Experimental Treatment
Group I: Very Low Calorie Diet ArmExperimental Treatment1 Intervention
We plan to perform a controlled, non-randomized, open-label, pilot clinical trial to evaluate the effect of an 8-week VLCD intervention on NAFLD.
Group II: Control ArmExperimental Treatment1 Intervention
The control group will consume a lower calorie diet and will be instructed to reduce their usual intake of normally consumed foods by up to 500 kcal per day but no less than 1200 kcal per day.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Iowa Health CareIowa City, IA
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Who Is Running the Clinical Trial?
University of IowaLead Sponsor
References
Feasibility of a Very Low Calorie Diet to Achieve a Sustainable 10% Weight Loss in Patients With Nonalcoholic Fatty Liver Disease. [2021]Nonalcoholic fatty liver disease (NAFLD) is the most common liver condition worldwide. A weight loss goal of ≥10% is the recommended treatment for NAFLD; however, only a minority of patients achieve this level of weight reduction with standard dietary approaches. This study aimed to determine whether a very low calorie diet (VLCD) is an acceptable and feasible therapy to achieve and maintain a ≥10% weight loss in patients with clinically significant NAFLD.
The use of very low-calorie diets in subjects with obesity complicated with nonalcoholic fatty liver disease: A scoping review. [2023]This scoping review synthesizes the existing research on the use of very low-calorie diets (VLCDs) in subjects with nonalcoholic fatty liver disease (NAFLD) and end-stage liver disease (ESLD). 19 studies were included, of which 5 were clinical trials, 11 were cohort studies, 1 was a case-control study, and 2 were case series totaling 968 subjects. About 17 studies were focused on patients with NAFLD while the two case series described in patients with ESLD on the transplant list or post-liver transplant. Six studies included subjects managed with VLCDs prior bariatric surgery. Most studies were short term and demonstrated acute improvement of diverse liver biomarkers including liver function tests, indices of hepatosteatosis and reduction in liver size. Adherence rates in these studies were between 69% and 93%. Eight studies did not report any adverse events and four subjects were reported to have discontinued VLCD due to adverse effects in two different studies. Aggregated adverse events were mild. Treatments based on VLCD in subjects with NAFLD seem to be safe and tolerable but can result in mild adverse effects. The findings of this scoping review suggest that the use of VLCD in patients with obesity complicated with NAFLD and potentially in ESLD appear to be effective to induce weight loss and to acutely reduce hepatosteatosis.
The evolution of very-low-calorie diets: an update and meta-analysis. [2009]Very-low-calorie diets (VLCDs), providing
Non-alcoholic Fatty Liver Disease in Morbidly Obese Individuals Undergoing Bariatric Surgery: Prevalence and Effect of the Pre-Bariatric Very Low Calorie Diet. [2018]Non-alcoholic fatty liver disease (NAFLD) affects 75 to 100% of the patients undergoing bariatric surgery (BSx), with non-alcoholic steatohepatitis (NASH) being present in 24 to 98% of the patients. We do not know whether these rates were before or after a very low calorie diet (VLCD) often prescribed before laparoscopic BSx and what is the prevalence of NAFLD post-VLCD.
Morphofunctional Changes After Sleeve Gastrectomy and Very Low Calorie Diet in an Animal Model of Non-Alcoholic Fatty Liver Disease. [2018]Non-alcoholic fatty liver disease (NAFLD) is the most prevalent chronic liver disease and is found in 70% of obese people. The evidence available to date suggests that bariatric surgery could be an effective treatment by reducing weight and also by improving metabolic complications in the long term. This work aimed to compare, in a diet-induced NAFLD animal model, the effect of both sleeve gastrectomy (SG) and very-low calorie diet (VLCD).
Very low-calorie diets. National Task Force on the Prevention and Treatment of Obesity, National Institutes of Health. [2022]To provide an overview of the published scientific information on the safety and efficacy of very low-calorie diets (VLCDs) and to provide rational recommendations for their use.
Risk of symptomatic gallstones and cholecystectomy after a very-low-calorie diet or low-calorie diet in a commercial weight loss program: 1-year matched cohort study. [2021]Concern exists regarding gallstones as an adverse event of very-low-calorie diets (VLCDs;
Adherence to low carbohydrate diets and non-alcoholic fatty liver disease: a case control study. [2023]Non-alcoholic fatty liver disease (NAFLD) is defined as the excessive accumulation of fat in the liver cells of people who do not drink alcohol. The aim of study is investigated the association between low carbohydrate diets (LCDs) and NAFLD.