Evaluation of the Effects of a Low Free Sugar Diet in Patients With Nonalcoholic Fatty Liver Disease

Study Overview
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Brief Summary
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To study the effects of a low free sugar diet on lipid profile, glycemic indices, liver enzymes, inflammatory factors and hepatic steatosis and fibrosis in patients with Nonalcoholic fatty liver disease, 50 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 2 and 3 will be randomly allocated to receive low free sugar diet or regular diet for 12 weeks; both groups will be advised to adherence the investigators' nutrition recommendation and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes,glycemic indices, some inflammatory markers, and liver fibrosis will be assessed and compared between groups.

Official Title
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Evaluation of the Effects of a Low Free Sugar Diet on Lipid Profile, Glycemic Indices, Liver Enzymes, Inflammatory Factors and Hepatic Steatosis and Fibrosis in Patients With Nonalcoholic Fatty Liver Disease

Conditions
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Nonalcoholic Fatty Liver Disease

Intervention / Treatment
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* Other: low free sugar diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 18 to 60 years Body Mass Index (BMI) between 25-40 Sonographic findings compatible with hepatic steatosis (degree 2 or more) Exclusion Criteria: Alcohol consumption pregnancy or lactation Other liver disease (viral,cirrhosis,...) Use of drugs such as phenytoin,tamoxifen,lithium A history of Cancer, autoimmune disease,Renal disease & Celiac disease, hypothyroidism or Cushing's syndrome Lack of desire to continue studying Have to use antibiotics with hepatotoxic drugs while studying Non-compliance with diet

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>low free sugar diet with nutrition and exercise recommendation | Other: low free sugar diet<br>* low free sugar diet with nutrition and exercise recommendation<br>|
| No Intervention: control<br>regular diet with nutrition and exercise recommendation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ALT | serum level of Alanine transaminase | 12 weeks | 
| AST | serum level of Aspartate transaminase | 12 weeks | 
| GGT | serum level of Gamma glutaminase | 12 weeks | 
| TG | serum level of Triglyceride | 12 weeks | 
| Total cholesterol | serum level of total cholesterol | 12 weeks | 
| LDL-c | serum level of LDL-Cholesterol | 12 weeks | 
| HDL-c | serum level of HDL-Cholesterol | 12 weeks | 
| FBS | serum level of Fasting blood sugar | 12 weeks | 
| Insulin | serum level of Insulin | 12 weeks | 
| hs-CRP | Serum level of high-sensitive C-reactive protein | 12 weeks | 
| TNF-a | Serum level of Tumor necrosis factor-a | 12 weeks | 
| NF-kb | Activity of Nuclear factor-B in peripheral monocellular cells | 12 weeks | 
| Liver fibrosis | Liver fibrosis according to fibroscan exam | 12 weeks |