Non Alcoholic Steatohepatitis
Conditions
Brief summary
To study the effects of Hesperidin, flaxseed and both together on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 100 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 2 and 3 will be randomly allocated to one of following four groups: control group, hesperidin group (2 capsules Hesperidin), flaxseed group (30 gram flaxseed) or flaxseed-hesperidin group (2 capsules Hesperidin and 30 gram flaxseed) for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes, some inflammatory markers, and liver fibrosis will be assessed and compared between groups.
Interventions
DIETARY_SUPPLEMENTDietary Supplement: hesperidin and flaxseed
2 capsules hesperidin and 30 g flaxseed
DIETARY_SUPPLEMENTDietary Supplement: hesperidin
2 capsules hesperidin
DIETARY_SUPPLEMENTDietary Supplement: flaxseed
30 g flaxseed
OTHERcontrol
no supplementation
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 70 Years
Healthy volunteers
No
Inclusion criteria
* Age of 18 to 70 years * Body Mass Index (BMI) between 25-40 * Sonographic findings compatible with hepatic steatosis (degree 2 or more)
Exclusion criteria
Diabetes Taking any kind of antibiotics two weeks before recruitment History of alcohol consumption pregnancy or lactation Professional athletes Other liver disease (viral/etc) Use of drugs such as calcium channel blockers, high dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs, lipid-lowering agents, metformin and vitamin E A history of Hypertension, Cardiovascular disease, Pulmonary disease, Renal disease & Celiac disease; Cirrhosis History of Upper GI surgery / Prior surgical procedures such as jejunoileal or jejunocolic bypass, gastroplasty Following program to lose weight in recent 3 mo A history of hypothyroidism or Cushing's syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| liver fibrosis | 12 weeks | assess by fibroscan |
Countries
Iran
Contacts
Primary Contactazita Hekmatdoost, MD.PhD
Outcome results
None listed