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COMPLETEDPHASE2/PHASE3

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

The Effects of Flaxseed Supplement on Lipid Profile, Liver Enzymes, Inflammatory Factors and Hepatic Fibrosis in Patients With Nonalcoholic Fatty Liver Disease

NCT02395900•National Nutrition and Food Technology Institute

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

Key Dates

Start Date

March 1, 2014

Primary Completion Date

August 1, 2014

Completion Date

January 1, 2015

Last Updated

March 22, 2016

Enrollment

ACTUAL participants

Conditions

Non Alcoholic Steatohepatitis

Interventions

Flaxseed

DIETARY_SUPPLEMENT

control

OTHER

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TERMINATED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 22, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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

Inclusion Criteria

Exclusion Criteria

Comparative Study Between Febuxostat Versus Vitamin E in Non-alcoholic Steatohepatitis Patients With Hyperuricemia

A Phase 2b Study of Icosabutate in Fatty Liver Disease

Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment

Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis

Effect of Patient Demographics, Comorbidities, and Medications on Severity of NASH Fibrosis

Efficacy and Safety of Montelukast in Non Alcoholic Steatohepatitis (NASH)