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

Non Alcoholic Steatohepatitis Clinical Trial

Official title:

Evaluation of the Effects of Hesperidin and Flaxseed Supplementation on Hepatic Enzymes, Inflammatory Factors, Lipid Profile, Blood Glucose, Insulin Sensitivity, and Hepatic Steatosis Grade in Patients With Non-alcoholic Fatty Liver Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03377153
• Other study ID #: 6757
• Status: Recruiting
• Phase: N/A
• First received: December 8, 2017
• Last updated: December 13, 2017
• Start date: June 1, 2017
• Est. completion date: March 20, 2018

Study information

• Verified date: April 2017
• Source: National Nutrition and Food Technology Institute
• Contact: azita Hekmatdoost, MD.PhD
• Phone: +98-21-22077424
• Email: a_hekmat2000[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 20, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non Alcoholic Steatohepatitis
• Non-alcoholic Fatty Liver Disease

Intervention

Dietary Supplement:
• hesperidin and flaxseed
2 capsuls hesperidin and 30 g flaxseed

Other:
• control
no supplementation

Locations

Country	Name	City	State
Iran, Islamic Republic of	National Nutrition and Food Technology Research Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
National Nutrition and Food Technology Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	liver fibrosis	assess by fibroscan	12 weeks
Secondary	body mass index	is universally expressed in units of kg/m2	12 weeks