The effect of Sour tea supplementation on liver enzymes, total antioxidant capacity, glycemic indicator, lipid profile and sonographic outcomes in patients with nonalcoholic fatty liver disease:A randomized controlled trial.
We aim to explore the effects of sour tea supplementation on NAFLD patients.
Design
This is a parallel double-blinded, randomized, placebo controlled trial.
Settings and conduct
Data collection will be conducted in the specialist’s clinic of Khorshid hospital of Isfahan. 70 Participants who definitely diagnose to have NAFLD will allocate into 2 groups of 35 subjects, one group will be the intervention and the other group will be the control group. Intervention group will take 500 mg of sour tea tablets, and control group will take placebo tablets with identical appearance for 8 weeks. At the beginning of the study, a blood sample and sonographic liver assessments will be derived from all patients. Outcomes of the disease will be compared by a blood sample test and liver sonographic assessments, after 8-weeks of interventions.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with the nonalcoholic fatty liver disease confirmed with imaging techniques. exclusion criteria: Alcohol consumption; Pregnant and lactating women; Any known forms of hepatic or metabolic disease except Non alcoholic fatty liver disease; Using antioxidant supplements; Hormone Therapy.
Intervention groups
Intervention group will take 500 mg of sour tea tablets, and control group will take placebo tablets with identical appearance containing starch for 8 weeks.
The effect of Sour tea supplementation on liver enzymes, total antioxidant capacity, glycemic indicator, lipid profile and sonographic outcomes in patients with nonalcoholic fatty liver disease:A randomized controlled trial.
Public title
The effect of Sour tea supplementation in nonalcoholic fatty liver disease.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with the nonalcoholic fatty liver disease confirmed with imaging techniques.
Body Mass Index (BMI) of them is greater than 24.9 and lower than 40.
Exclusion criteria:
Alcohol consumption
Pregnant and lactating women
Any known forms of hepatic or metabolic disease except NAFLD, such as hereditary hemochromatosis, Wilson’s disease, cirosis, other metabolic disease
history of gastric bypass or intestine surgery
Taking hepatotoxic drugs such as calcium channel blocker, methotrexate, amiodarone, chloroquine and anti inflammatory drugs
Using antioxidant supplements
Hormone Therapy
Patients with a history of Cushing’s syndrome
renal failure
Participants with less than 80% are going to be excluded.
Age
From 23 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects will be allocating into intervention or placebo group by permuted block randomization method.
Blinding (investigator's opinion)
Double blinded
Blinding description
Sour tea supplement and placebo will have identical appearance.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Isfahan University of Medical Sciences
Street address
Department of Clinica Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2018-03-04, 1396/12/13
Ethics committee reference number
IR.MUI.REC.1396.2.137
Health conditions studied
1
Description of health condition studied
Nonalcoholic Fatty Liver Disease.
ICD-10 code
K75.81
ICD-10 code description
Nonalcoholic steatohepatitis (NASH)
Primary outcomes
1
Description
Liver enzymes (ALT, AST)
Timepoint
The first day of the study and the last day of 8th week
Method of measurement
Using Microgram/ml - laboratory kit
2
Description
Lipid profile (TG, HDL, Total cholestrol)
Timepoint
The first day of the study and the last day of 8th week
Method of measurement
laboratory kit
3
Description
Liver steatosis index
Timepoint
The first day of the study and the last day of 8th week
Method of measurement
Sonography
4
Description
Fasting blood sugar
Timepoint
The first day of the study and the last day of 8th week
Method of measurement
laboratory kit
5
Description
Total antioxidant capacity
Timepoint
The first day of the study and the last day of 8th week
Method of measurement
laboratory kit
Secondary outcomes
1
Description
Waist to hip ratio
Timepoint
The first day of the study and the last day of 8th week
Method of measurement
Non-stretchable tape without any pressure
2
Description
Body Mass Index (BMI)
Timepoint
The first day of the study and the last day of 8th week
Method of measurement
Weight (kilograms) divided by the square of height (meters)
3
Description
Sistolic and diastolic blood pressure
Timepoint
The first day of the study and the last day of 8th week
Method of measurement
By mercury sphygmomanometer
Intervention groups
1
Description
Intervention group will take 500 mg of sour tea tablets, for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group will take placebo tablets with identical appearance containing starch for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
khorshid Hospital
Full name of responsible person
Mohammad hassan entezari
Street address
Khorshid Hospital, Ostandari Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8487
Fax
+98 31 3668 1378
Email
entezari@hlth.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mohammad hassan entezari
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8487
Fax
+98 31 3668 1378
Email
entezari@hlth.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Izadi
Position
MSc Student of Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Department of Clinical Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8487
Fax
+98 31 3668 1378
Email
Fatemeh.Izadi1993@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad hassan entezari
Position
Ph.D of nutrition, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of Clinical Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8487
Fax
+98 31 3668 1378
Email
Entezari@hlth.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Izadi
Position
MSc Student of Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Department of Clinical Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8487
Fax
+98 31 3668 8487
Email
Fatemeh.Izadi1993@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available