The Effects of Hesperidin and Flaxseed on Biochemical Factors and Hepatic Fibrosis in Nonalcoholic Fatty Liver Disease

Not Applicable

• Conditions: Non Alcoholic Steatohepatitis
• Interventions: Dietary Supplement: hesperidin and flaxseed; Other: control

• Registration Number: NCT03377153
• Lead Sponsor: National Nutrition and Food Technology Institute

Brief Summary

To study the effects of Hesperidin and flaxseed supplement on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 50 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 2 and 3 will be randomly allocated to contol group or 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-04
• Study Start: 2017-06-01
• Study First Submitted: 2017-12-08
• Study First Submitted QC: 2017-12-13
• Last Update Submitted: 2017-12-13
• Study First Posted: 2017-12-19
• Last Update Posted: 2017-12-19
• Primary Completion: 2018-02-01
• Study Completion: 2018-03-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hesperidin and Flaxseed	hesperidin and flaxseed	-
control	control	-

Primary Outcome Measures

Name	Time	Method
liver fibrosis	12 weeks	assess by fibroscan

Secondary Outcome Measures

Name	Time	Method
body mass index	12 weeks	is universally expressed in units of kg/m2

Trial Locations

Locations (1)

National Nutrition and Food Technology Research Institute; 🇮🇷 Tehran, Iran, Islamic Republic of