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

Sponsor

National Nutrition and Food Technology Institute (Other)

Overall Status

Completed

CT.gov ID

NCT02395900

Collaborator

(none)

Enrollment

Arms

10.1

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non Alcoholic Steatohepatitis	Dietary Supplement: Flaxseed Other: control	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

Aug 1, 2014

Actual Study Completion Date :

Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Flaxseed 30 grams Flaxseed powder	Dietary Supplement: Flaxseed
Placebo Comparator: control dietary and exercise recommendation	Other: control Other Names: no supplement

Arm

Intervention/Treatment

Active Comparator: Flaxseed

30 grams Flaxseed powder

Dietary Supplement: Flaxseed

Placebo Comparator: control

dietary and exercise recommendation

Other: control

Other Names:

no supplement

Outcome Measures

Primary Outcome Measures

Alaninaminotransferase (ALT) [12 weeks]
Liver fibrosis [12 weeks]

Secondary Outcome Measures

Body Mass Index (BMI) [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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
A history of hypothyroidism or Cushing's syndrome

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

National Nutrition and Food Technology Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr Azita Hekmatdoost, Principal Investigator, National Nutrition and Food Technology Institute

ClinicalTrials.gov Identifier:

NCT02395900

Other Study ID Numbers:

First Posted:

Mar 24, 2015

Last Update Posted:

Mar 22, 2016

Last Verified:

Mar 1, 2016

Additional relevant MeSH terms:

Liver Diseases

Fatty Liver

Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Mar 22, 2016