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

Primary Purpose

Non Alcoholic Steatohepatitis

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Flaxseed

control

About this trial

This is an interventional treatment trial for Non Alcoholic Steatohepatitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Flaxseed

control

Arm Description

30 grams Flaxseed powder

dietary and exercise recommendation

Outcomes

Primary Outcome Measures

Alaninaminotransferase (ALT)

Liver fibrosis

Secondary Outcome Measures

Body Mass Index (BMI)

Full Information

NCT ID

NCT02395900

First Posted

March 18, 2015

Last Updated

March 21, 2016

Sponsor

National Nutrition and Food Technology Institute

1. Study Identification

Unique Protocol Identification Number

NCT02395900

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Nutrition and Food Technology Institute

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Alcoholic Steatohepatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Flaxseed

Arm Type

Active Comparator

Arm Description

30 grams Flaxseed powder

Arm Title

control

Arm Type

Placebo Comparator

Arm Description

dietary and exercise recommendation

Intervention Type

Dietary Supplement

Intervention Name(s)

Flaxseed

Intervention Type

Other

Intervention Name(s)

control

Other Intervention Name(s)

no supplement

Primary Outcome Measure Information:

Title

Alaninaminotransferase (ALT)

Time Frame

12 weeks

Title

Liver fibrosis

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Body Mass Index (BMI)

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

Learn more about this trial

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

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