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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02395900
Other study ID # 567
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received March 18, 2015
Last updated March 21, 2016
Start date March 2014
Est. completion date January 2015

Study information

Verified date March 2016
Source National Nutrition and Food Technology Institute
Contact n/a
Is FDA regulated No
Health authority IRAN: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date January 2015
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Flaxseed

Other:
control


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Nutrition and Food Technology Institute

Outcome

Type Measure Description Time frame Safety issue
Primary Alaninaminotransferase (ALT) 12 weeks Yes
Primary Liver fibrosis 12 weeks No
Secondary Body Mass Index (BMI) 12 weeks No
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