The Effects of Flaxseed Supplement on Biochemical Factors and Hepatic Fibrosis in Patients With Nonalcoholic Fatty Liver Disease

NCT ID: NCT02395900

Last Updated: 2016-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-01-31

Brief Summary

To study the effects of 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 receive placebos or 30 grams Flaxseed powder 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.

Conditions

Non Alcoholic Steatohepatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Flaxseed

30 grams Flaxseed powder

Group Type: ACTIVE_COMPARATOR

Flaxseed

Intervention Type: DIETARY_SUPPLEMENT

control

dietary and exercise recommendation

Group Type: PLACEBO_COMPARATOR

control

Intervention Type: OTHER

Interventions

Flaxseed

Intervention Type: DIETARY_SUPPLEMENT

control

Intervention Type: OTHER

Other Intervention Names

no supplement

Eligibility Criteria

Inclusion Criteria

• Age of 18 to 70 years
• Body Mass Index (BMI) between 25-40
• Serum alaninaminotransferase more than 1.5 fold of upper limit of normal range
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Nutrition and Food Technology Institute

OTHER

Sponsor Role: lead

Responsible Party

Dr Azita Hekmatdoost

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

567

Identifier Type: -

Identifier Source: org_study_id