Back to resultsThe Effect of Supplementation of Flaxseed, Hesperidin, Flaxseed and Hesperidin Together in Non-alcoholic Fatty Liver Disease: A Randomized, Controlled Study
Primary Purpose
Non Alcoholic Steatohepatitis
Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Dietary Supplement: hesperidin and flaxseed
Dietary Supplement: hesperidin
Dietary Supplement: flaxseed
control
Sponsored by
About this trial
This is an interventional treatment trial for Non Alcoholic Steatohepatitis
Eligibility Criteria
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
Sites / Locations
- National Nutrition and Food Technology Research InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
hesperidin and flaxseed
control
flaxseed
hesperidin
Arm Description
Outcomes
Primary Outcome Measures
liver fibrosis
assess by fibroscan
Secondary Outcome Measures
Full Information
NCT ID
NCT03734510
First Posted
November 6, 2018
Last Updated
November 6, 2018
Sponsor
National Nutrition and Food Technology Institute
1. Study Identification
Unique Protocol Identification Number
NCT03734510
Brief Title
The Effect of Supplementation of Flaxseed, Hesperidin, Flaxseed and Hesperidin Together in Non-alcoholic Fatty Liver Disease: A Randomized, Controlled Study
Official Title
Evaluation of the Effects of Supplementation of Flaxseed, Hesperidin, Flaxseed and Hesperidin Together on Hepatic Enzymes, Inflammatory Factors, Lipid Profile, Blood Glucose, Insulin Sensitivity, and Hepatic Steatosis Grade in Patients With Non-alcoholic Fatty Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
January 1, 2019 (Anticipated)
Study Completion Date
February 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Nutrition and Food Technology Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To study the effects of Hesperidin, flaxseed and both together on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 100 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 2 and 3 will be randomly allocated to one of following four groups: control group, hesperidin group (2 capsules Hesperidin), flaxseed group (30 gram flaxseed) or flaxseed-hesperidin group (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.
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
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hesperidin and flaxseed
Arm Type
Active Comparator
Arm Title
control
Arm Type
Placebo Comparator
Arm Title
flaxseed
Arm Type
Active Comparator
Arm Title
hesperidin
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary Supplement: hesperidin and flaxseed
Intervention Description
2 capsules hesperidin and 30 g flaxseed
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary Supplement: hesperidin
Intervention Description
2 capsules hesperidin
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary Supplement: flaxseed
Intervention Description
30 g flaxseed
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
no supplementation
Primary Outcome Measure Information:
Title
liver fibrosis
Description
assess by fibroscan
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
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
azita Hekmatdoost, MD.PhD
Phone
+982122357484
Email
a_hekmat2000@yahoo.com
Facility Information:
Facility Name
National Nutrition and Food Technology Research Institute
City
Tehran
State/Province
Iran (the Islamic Republic Of)
ZIP/Postal Code
1981619573
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Azits Hekmatdoost, MD,PhD
Phone
+982122357484
12. IPD Sharing Statement
Learn more about this trial
The Effect of Supplementation of Flaxseed, Hesperidin, Flaxseed and Hesperidin Together in Non-alcoholic Fatty Liver Disease: A Randomized, Controlled Study
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