The Effect of Synbiotics Supplement on Lipid Profile, Liver Enzymes, Inflammatory Factors and Hepatic Fibrosis in Lean and Normal Weight Patients With Nonalcoholic Fatty Liver
Primary Purpose
Non Alcoholic Steatohepatitis
Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
synbiotic
Placebo
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) below 25
- 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
Sites / Locations
- NNFTRI clinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Synbiotic
maltodexterin
Arm Description
2 synbiotic capsules for 28 weeks
two capsules per day for 28 weeks
Outcomes
Primary Outcome Measures
Alaninaminotransferase (ALT) (UL)
by biochemical method
hepatic steatosis (cap score)
using transient elastography
Secondary Outcome Measures
Body Mass Index (BMI) (kg/m2)
using formula
Full Information
NCT ID
NCT02530138
First Posted
August 18, 2015
Last Updated
August 19, 2015
Sponsor
National Nutrition and Food Technology Institute
1. Study Identification
Unique Protocol Identification Number
NCT02530138
Brief Title
The Effect of Synbiotics Supplement on Lipid Profile, Liver Enzymes, Inflammatory Factors and Hepatic Fibrosis in Lean and Normal Weight Patients With Nonalcoholic Fatty Liver
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Nutrition and Food Technology Institute
4. Oversight
5. Study Description
Brief Summary
Introduction: Currently, Nonalcoholic Fatty Liver Disease (NAFLD) is the most common liver disease in the world. The only approved treatment for it is lifestyle modification and weight loss; however, there is no evidence for patients with normal or low body mass index (BMI).
The aim of this study is to evaluate the efficacy of symbiotic supplementation in NAFLD patients with normal or low BMI.
Methods and analysis: In this randomized, double-blind, placebo-controlled clinical trial protocol, 21 cases and 21 controls will be individually matched based on age and sex. This 42 patients with NAFLD will be supplemented twice daily for 28 wk with either a synbiotic or a placebo capsule. Both groups will be advised to follow an energy balanced diet and physical activity recommendations.
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
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Synbiotic
Arm Type
Active Comparator
Arm Description
2 synbiotic capsules for 28 weeks
Arm Title
maltodexterin
Arm Type
Placebo Comparator
Arm Description
two capsules per day for 28 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
synbiotic
Intervention Description
2 symbiotics capsules per day for 28 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
2 placebo capsules per day for 28 weeks
Primary Outcome Measure Information:
Title
Alaninaminotransferase (ALT) (UL)
Description
by biochemical method
Time Frame
28 weeks
Title
hepatic steatosis (cap score)
Description
using transient elastography
Time Frame
28 weeks
Secondary Outcome Measure Information:
Title
Body Mass Index (BMI) (kg/m2)
Description
using formula
Time Frame
28 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) below 25
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Azita Hakmatdost, MD, PhD
Phone
9123065084
Email
a_hekmat2000@yahoo.com
Facility Information:
Facility Name
NNFTRI clinic
City
Tehran
ZIP/Postal Code
19435
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Azita Hekmatdoost, MD, PhD
Phone
9123065084
Email
a_hekmat2000@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
The Effect of Synbiotics Supplement on Lipid Profile, Liver Enzymes, Inflammatory Factors and Hepatic Fibrosis in Lean and Normal Weight Patients With Nonalcoholic Fatty Liver
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