Supplementation effect of green coffee bean extract on lipid profile, inflammatory and oxidative stress biomarkers, insulin resistance and liver enzymes in overweight and obese patients with nonalcoholic fatty liver disease(NAFLD).
The purpose of this study is to assess the effect of green coffee bean extract on lipid profile, inflammatory and oxidative stress biomarkers, insulin resistance and liver enzymes in overweight and obese patients with nonalcoholic fatty liver disease (NAFLD). In this randomized, double blind, placebo controlled trial with parallel design,44 patients suffering from NAFLD will be selected among patients referring to Gastroenterology Clinic of Imam Khomeini Hospital in Ahvaz. Participants will be randomly assigned to intervention or control group (1:1 ratio) based on the blocked randomization method. The intervention and control groups respectively will be received green coffee bean extract capsule (1g per day) and Nokhodchi flour capsule (1g per day) as placebo for 8 weeks. Inclusion criteria include Patients aged between 20 to 70 years who will be diagnosed with NAFLD by ultrasonography scan and increased levels of liver enzymes; and have a Body Mass Index (BMI) grater than 24.9 and lower than 35. Exclusion criteria for the study will be alcohol consumption; pregnant and lactating women; any forms of hepatic or metabolic disease except NAFLD; taking hepatotoxic drugs; using nutrition supplements and have any history of gastric bypass or intestine surgery. At the beginning and end of the study different variables of the study include blood levels of lipid profile, inflammatory and oxidative stress biomarkers, insulin resistance and liver enzymes will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030626941N1
Registration date:2016-04-19, 1395/01/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-19, 1395/01/31
Registrant information
Name
Hedayat allah Shahmohammadi
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8319
Email address
shahmohammadi.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2016-03-24, 1395/01/05
Expected recruitment end date
2016-04-18, 1395/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Supplementation effect of green coffee bean extract on lipid profile, inflammatory and oxidative stress biomarkers, insulin resistance and liver enzymes in overweight and obese patients with nonalcoholic fatty liver disease(NAFLD).
Public title
Effect of green coffee bean extract supplementation on nonalcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Men or women aged between 20 to 70 years old who will be diagnosed with NAFLD by ultrasonography scan (with steatosis score equal or greater than 1) and increased levels of liver enzymes (serum levels of alanine aminotransferase and aspartate aminotransferase more than 40 U/L); and Body Mass Index (BMI) of them is grater than 24.9 and lower than 35.
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, diabetes and other metabolic disease; Any history of gastric bypass or intestine surgery; Taking hepatotoxic drugs such as calcium channel blocker, methotrexate, amiodarone, chloroquine and anti inflammatory drugs; Using nutrition supplements; Hormone Therapy; and Patients with a history of hypothyroidism, Cushing’s syndrome, renal failure, and kidney stones.
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
participants will be randomly assigned to intervention or control group (1:1 ratio) based on the blocked randomization method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University Of Medical Sciences
Street address
Golestan Ave., Ahvaz, Ahvaz Jundishapur University of Medical Sciences, Ethics Committee of Ahvaz Jundishapur University Of Medical Sciences
City
Ahvaz
Postal code
Approval date
2016-03-05, 1394/12/15
Ethics committee reference number
IR.AJUMS.REC. 1394.710
Health conditions studied
1
Description of health condition studied
Nonalcoholic Fatty Liver Disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Liver steatosis index
Timepoint
Before and after intervention
Method of measurement
Sonography
2
Description
Insulin Resistance (IR)
Timepoint
Before and after intervention
Method of measurement
Based on HOMA IR equation
3
Description
Liver enzymes (ALT, AST, ALP)
Timepoint
Before and after intervention
Method of measurement
Microgram/ml - laboratory kit
4
Description
Tomor necrosis factor alpha (TNF alpha)
Timepoint
Before and after intervention
Method of measurement
ELISA
5
Description
Serum Total Anti Oxidant Capacity (TAOC)
Timepoint
Before and after intervention
Method of measurement
ELISA
6
Description
High sensitive C reactive protein
Timepoint
Before and after intervention
Method of measurement
ELISA
7
Description
Blood free fatty acids
Timepoint
Before and after intervention
Method of measurement
ELISA
8
Description
Lipid profile (TG, LDL, HDL, Total cholestrol)
Timepoint
Before and after intervention
Method of measurement
laboratory kit
9
Description
Fasting Blood Sugar (FBS)
Timepoint
Before and after intervention
Method of measurement
Colorimetric enzymatic method
10
Description
Insulin
Timepoint
Before and after intervention
Method of measurement
ELISA
Secondary outcomes
1
Description
Waist to hip ratio
Timepoint
Before and after intervention
Method of measurement
Non-stretchable tape without any pressure
2
Description
Body Mass Index (BMI)
Timepoint
Before and after intervention
Method of measurement
Weight (kilograms) divided by the square of height (meters)
3
Description
Sistolic and diastolic blood pressure
Timepoint
Before and after intervention
Method of measurement
By mercury sphygmomanometer
Intervention groups
1
Description
Intervention group: All patients will receive 1g green coffee bean extract capsules once daily for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group: All patients will receive 1g placebo capsules (Nokhodchi flour) once daily for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastroenterology Outpatient Clinic affiliated to Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Eskandar Hajiani
Street address
Azadegan Ave., Ahvaz, Department of Gasteroenterology, Imam Khomeini Hospital
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Nader Saki, Deputy of research development
Street address
Golestan Ave., Ahvaz, Vice Chancellor for research of Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hedayat allah shahmohammadi
Position
MSc student of Nutrition
Other areas of specialty/work
Street address
Golestan Ave., Ahvaz, Paramedical School, Department of Nutrition, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3333 3050
Fax
Email
shahmohammadi.h@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences
Full name of responsible person
Seyyed ahmad hosseini
Position
PhD of Clinical Biochemistry
Other areas of specialty/work
Street address
Golestan Ave., Ahvaz, Paramedical School, Department of Nutrition, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3333 3050
Fax
Email
seyedahmadhosseini@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hedaiat allah shahmohammadi
Position
MSc student of Nutrition
Other areas of specialty/work
Street address
Golestan Ave., Ahvaz, Paramedical School, Department of Nutrition, Ahvaz Jundishapur University of Medical Sciences