This prospective randomized double blinded placebo controlled trail aims to seek whether daily intake of 1500 mg oral Cinnamon exceeds placebo in improving clinical, serologic and sonographic characteristics of NAFLD patients during a 3 month treatment program. This parallel designed trail will be conducted in gastroenterology outpatient clinic affiliated to Ahvaz University of Medical Sciences starting from June 2015 to October 2015. Participants are randomly allocated to one treatment arm with 750 mg cinnamon capsules twice daily for three months, and one control arm receiving sham capsules of identical shape and size with the same duration. The primary outcome measures are changes in clinical, serologic and radiologic characteristics of NAFLD patients involved in the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062922977N1
Registration date:2015-07-20, 1394/04/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-20, 1394/04/29
Registrant information
Name
Eskandar Hajiani
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1292 1839
Email address
hajiani-e@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Development Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-07-15, 1394/04/24
Expected recruitment end date
2015-10-15, 1394/07/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating Cinnamon Effects on Clinical, Serologic and Sonographic Characteristics of Non-Alcoholic Fatty Liver Disease patients
Public title
Evaluating Cinnamon Effects on Clinical, Serologic and Sonographic Characteristics of Non-Alcoholic Fatty Liver Disease patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria (consenting NAFLD patients 18-65 years old; evidence of fatty liver in ultrasonography with a score of 2 or more or alanine aminotransferase (ALT) levels up to 60 U/L;) and exclusion criteria (daily alcohol consumption above 20 g in women and 30 g in men; incidence of other acute or chronic liver diseases (hepatitis B, C, etc); cirrhosis; biliary disease; known autoimmune disease; malignancy and/or inherited disorders that affect liver status (an iron storage disease, Wilson disease, etc); pregnancy and lactation; metformin consumption; incidence of hyperlipidemia or hypertension requiring medication; previous supplementation of vitamin E; usage of hepatotoxic drugs over the past 6 months prior to the trial; developing hypersensitivity to cinnamon or occurring any adverse effects; acquiring viral/autoimmune/metabolic hepatic disorders during the study; alcohol intake; withdrawing treatment or being lost to follow up clinical and para-clinical examinations)
Age
From 18 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Ethics Committee, It & Research Assistance Center, University complex, Golestan Hwy
City
Ahvaz
Postal code
Approval date
2015-04-29, 1394/02/09
Ethics committee reference number
AJUMS.REC.1394.45
Health conditions studied
1
Description of health condition studied
Non-Alcoholic Fatty Liver Disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Fatty liver score in ultrasound
Timepoint
Before intervention and after three months of intervention
Method of measurement
Ultrasound evaluations of abdomen
2
Description
Fasting Blood Sugar (FBS)
Timepoint
Before intervention and after three months of intervention
Method of measurement
colorimetric enzymatic method
3
Description
HbA1C
Timepoint
Before intervention and after three months of intervention
Method of measurement
measured by affinity chromatographic method
4
Description
Triglycerides, Total Cholesterol, Low-density Lipoprotein (LDL), and High-density Lipoprotein (HDL)
Timepoint
Before intervention and after three months of intervention
Method of measurement
Colorimetric Enzymatic Method
5
Description
Serum ALT and AST Concentration
Timepoint
Before intervention and after three months of intervention
Method of measurement
UV Test
6
Description
Weight (kg)
Timepoint
Before intervention and after three months of intervention
Method of measurement
Digital scale with minimal clothing and no shoes
7
Description
Body Mass Index (BMI)
Timepoint
Before intervention and after three months of intervention
Method of measurement
Weight (kilograms) divided by the square of height (meters)
8
Description
Waist Circumference
Timepoint
Before intervention and after three months of intervention
Method of measurement
non-stretchable tape without any pressure (cm)
Secondary outcomes
empty
Intervention groups
1
Description
In the treatment group (Cinnamon group) all patients will receive 750 mg cinnamon capsules twice daily for 12 weeks starting after initial assessments
Category
Treatment - Drugs
2
Description
In the control group, all patients will receive 750 mg placebo capsules (wheat flour) of identical shape and color twice daily for 12 weeks starting after initial assessments
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastroenterology Outpatient Clinic affiliated to Ahvaz University of Medical Sciences
Full name of responsible person
Eskandar Hajiani
Street address
Department of gasteroenterology, Imam Khomeini Hospital, Azadegan Ave Ahvaz Khuestan Iran, Islamic Republic Of
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research Development Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Nader Saki, Deputy of research development
Street address
IT & research center, University complex
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research Development 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
Eskandar Hajiani
Position
Associate Professor of Gastroenterology
Other areas of specialty/work
Street address
Department of gastroenterology, Imam Khomeini Hospital, Azadegan Ave
City
Ahvaz
Postal code
Phone
+98 61 1292 1839
Fax
+98 61 1292 1839
Email
hajiani-e@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
Eskandar Hajiani
Position
Associate Professor of Gastroenterology
Other areas of specialty/work
Street address
Department of gastroenterology, Imam Khomeini Hospital, Azadegan Ave
City
Ahvaz
Postal code
Phone
+98 61 1292 1839
Fax
Email
hajiani-e@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Eskandar Hajiani
Position
Associate Professor of Gastroenterology
Other areas of specialty/work
Street address
Department of gastroenterology, Imam Khomeini Hospital, Azadegan Ave
City
Ahvaz
Postal code
Phone
+98 61 1292 1839
Fax
Email
Hajiani-e@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)