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Dietary Supplement

Very Low Calorie Diet for Non-alcoholic Fatty Liver Disease

Phase 1

Recruiting

Led By Marcelo L Correia, MD PhD

Research Sponsored by University of Iowa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

BMI ≥ 30 kg/m2 and ≤ 50 kg/m2

Male and female subjects with age ≥ 18 years old and < 70 years old

Must not have

Porphyria

Coexisting liver disease or end-stage liver disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a very low-calorie diet can help improve non-alcoholic fatty liver disease (NAFLD) by reducing liver steatosis (fatty infiltration) and fibrosis (scarring). If successful, this could establish the diet as a clinically effective option for treating NAFLD, particularly for patients who are ineligible or don't have access to bariatric surgery.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of VLCD may include fatigue due to energy deficit; nutrient deficiencies if not properly managed; digestive changes like constipation; gallstones from rapid weight loss; and possible mood swings or irritability.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BMI is between 30 and 50.

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I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have porphyria.

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I have liver disease or my liver is failing.

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My thyroid is overactive and not controlled by medication.

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I need oxygen therapy for my COPD.

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I have heart failure.

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My kidney function is very low.

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I have had or currently have gallbladder inflammation and have not had my gallbladder removed.

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I have unstable chest pain.

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I have had kidney stones made of uric acid before.

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I have gout.

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I have Type 1 diabetes.

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I have type 2 diabetes and use insulin.

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I am taking warfarin, lithium, or prednisone (20mg or more daily).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Liver fibrosis

Liver steatosis

Secondary study objectives

Fecal microbiome

Micro RNA (miRNA)

Platelet function

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 15Eligibility criteria met