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The Effects of Hesperidin and Flaxseed on Biochemical Factors and Hepatic Fibrosis in Nonalcoholic Fatty Liver Disease

Primary Purpose

Non Alcoholic Steatohepatitis

Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
hesperidin and flaxseed
control
Sponsored by
National Nutrition and Food Technology Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Alcoholic Steatohepatitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Type

Active Comparator

Placebo Comparator

Arm Label

Hesperidin and Flaxseed

control

Arm Description

Outcomes

Primary Outcome Measures

liver fibrosis
assess by fibroscan

Secondary Outcome Measures

body mass index
is universally expressed in units of kg/m2

Full Information

First Posted
December 8, 2017
Last Updated
December 13, 2017
Sponsor
National Nutrition and Food Technology Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03377153
Brief Title
The Effects of Hesperidin and Flaxseed on Biochemical Factors and Hepatic Fibrosis in Nonalcoholic Fatty Liver Disease
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
February 1, 2018 (Anticipated)
Study Completion Date
March 20, 2018 (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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

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
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hesperidin and Flaxseed
Arm Type
Active Comparator
Arm Title
control
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
hesperidin and flaxseed
Intervention Description
2 capsuls hesperidin and 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
Secondary Outcome Measure Information:
Title
body mass index
Description
is universally expressed in units of kg/m2
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
+98-21-22077424
Email
a_hekmat2000@yahoo.com
Facility Information:
Facility Name
National Nutrition and Food Technology Research Institute
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Azits Hekmatdoost

12. IPD Sharing Statement

Learn more about this trial

The Effects of Hesperidin and Flaxseed on Biochemical Factors and Hepatic Fibrosis in Nonalcoholic Fatty Liver Disease

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