- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03377153
The Effects of Hesperidin and Flaxseed on Biochemical Factors and Hepatic Fibrosis in Nonalcoholic Fatty Liver Disease
December 13, 2017 updated by: Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
Evaluation of the Effects of Hesperidin and Flaxseed Supplementation on Hepatic Enzymes, Inflammatory Factors, Lipid Profile, Blood Glucose, Insulin Sensitivity, and Hepatic Steatosis Grade in Patients With Non-alcoholic Fatty Liver Disease
To study the effects of Hesperidin and 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 contol group or 2 capsules Hesperidin and 30 gram flaxseed 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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of
- Recruiting
- National Nutrition and Food Technology Research Institute
-
Contact:
- Azits Hekmatdoost
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age of 18 to 70 years
- Body Mass Index (BMI) between 25-40
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: control
|
no supplementation
|
ACTIVE_COMPARATOR: Hesperidin and Flaxseed
|
2 capsuls hesperidin and 30 g flaxseed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
liver fibrosis
Time Frame: 12 weeks
|
assess by fibroscan
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
body mass index
Time Frame: 12 weeks
|
is universally expressed in units of kg/m2
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 1, 2017
Primary Completion (ANTICIPATED)
February 1, 2018
Study Completion (ANTICIPATED)
March 20, 2018
Study Registration Dates
First Submitted
December 8, 2017
First Submitted That Met QC Criteria
December 13, 2017
First Posted (ACTUAL)
December 19, 2017
Study Record Updates
Last Update Posted (ACTUAL)
December 19, 2017
Last Update Submitted That Met QC Criteria
December 13, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6757
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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