Nonalcoholic Fatty Liver Disease
Conditions
Brief summary
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.
Interventions
OTHERlow free sugar diet
low free sugar diet with nutrition and exercise recommendation
Sponsors
National Nutrition and Food Technology Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Age of 18 to 60 years 2. Body Mass Index (BMI) between 25-40 3. Sonographic findings compatible with hepatic steatosis (degree 2 or more)
Exclusion criteria
1. Alcohol consumption 2. pregnancy or lactation 3. Other liver disease (viral,cirrhosis,...) 4. Use of drugs such as phenytoin,tamoxifen,lithium 5. A history of Cancer, autoimmune disease,Renal disease & Celiac disease, hypothyroidism or Cushing's syndrome 6. Lack of desire to continue studying 7. Have to use antibiotics with hepatotoxic drugs while studying 8. Non-compliance with diet
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ALT | 12 weeks | serum level of Alanine transaminase |
| AST | 12 weeks | serum level of Aspartate transaminase |
| GGT | 12 weeks | serum level of Gamma glutaminase |
| TG | 12 weeks | serum level of Triglyceride |
| Total cholesterol | 12 weeks | serum level of total cholesterol |
| LDL-c | 12 weeks | serum level of LDL-Cholesterol |
| HDL-c | 12 weeks | serum level of HDL-Cholesterol |
| FBS | 12 weeks | serum level of Fasting blood sugar |
| Insulin | 12 weeks | serum level of Insulin |
| hs-CRP | 12 weeks | Serum level of high-sensitive C-reactive protein |
| TNF-a | 12 weeks | Serum level of Tumor necrosis factor-a |
| NF-kb | 12 weeks | Activity of Nuclear factor-B in peripheral monocellular cells |
| Liver fibrosis | 12 weeks | Liver fibrosis according to fibroscan exam |
Countries
Iran
Contacts
Primary ContactAzita Hekmatdoost, MD,PhD
Outcome results
None listed