The Effects of Flaxseed Supplement on Biochemical Factors and Hepatic Fibrosis in Patients With Nonalcoholic Fatty Liver Disease
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2014
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 18, 2015
CompletedFirst Posted
Study publicly available on registry
March 24, 2015
CompletedMarch 22, 2016
March 1, 2016
5 months
March 18, 2015
March 21, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Alaninaminotransferase (ALT)
12 weeks
Liver fibrosis
12 weeks
Secondary Outcomes (1)
Body Mass Index (BMI)
12 weeks
Study Arms (2)
Flaxseed
ACTIVE COMPARATOR30 grams Flaxseed powder
control
PLACEBO COMPARATORdietary and exercise recommendation
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 18, 2015
First Posted
March 24, 2015
Study Start
March 1, 2014
Primary Completion
August 1, 2014
Study Completion
January 1, 2015
Last Updated
March 22, 2016
Record last verified: 2016-03