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

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ClinicalTrials.gov Identifier: NCT02395900
Recruitment Status : Completed
First Posted : March 24, 2015
Last Update Posted : March 22, 2016
Sponsor:
Information provided by (Responsible Party):
Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute

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

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Study Type : Interventional  (Clinical Trial)
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 : March 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : January 2015


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




Primary Outcome Measures :
  1. Alaninaminotransferase (ALT) [ Time Frame: 12 weeks ]
  2. Liver fibrosis [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Body Mass Index (BMI) [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Dr Azita Hekmatdoost, Principal Investigator, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier: NCT02395900     History of Changes
Other Study ID Numbers: 567
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases