The aim of this study was to evaluate the effects of dark chocolate on the serum levels of protein reactive- C, liver enzymes, nuclear factor kappa B, malondialdehyde and total antioxidant capacity in patients with non-alcoholic fatty liver is. This study is a randomized and controlled study was performed on 42 patients. Patients were randomly divided into two groups: case group received a daily 30 mg of dark chocolate and control group was without consuming dark chocolate. The intervention period was 12 weeks. Variables including anthropometric indices, blood pressure, inflammatory markers, liver enzymes, fasting blood sugar and lipid profile were measured before and after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201303264545N2
Registration date:2014-12-25, 1393/10/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-12-25, 1393/10/04
Registrant information
Name
Pezhman Alavi nejad
Name of organization / entity
Ahvaz Jondishapur University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1391 2533
Email address
ehajiani@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research institute for infectious diseases of digestive system,
School of Medicine, Ahvaz Jundi Shapur University of Medical
Sciences
Expected recruitment start date
2013-10-04, 1392/07/12
Expected recruitment end date
2013-12-31, 1392/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of dark chocolate on serum levels of liver enzymes, inflammation and oxidative stress status in patients with non alcoholic fatty liver disease
Public title
Non alcoholic fatty liver disease and dark chocolate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 19-59 years old patient with non alcoholic fatty liver disease
Exclusion criteria: Patients who have diabetes, cardiovascular, kidney and other hepatic diseases; Pregnant or lactating women; Smoking; Alcohol consumption; Use of dietary supplements.
Age
From 19 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
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
Ethic commity of Ahvaz Jundishapur university of medical sciences
Street address
center of clinical researches, Ahvaz Jundishapur university of medical sciences
City
Ahvaz
Postal code
Approval date
2013-08-07, 1392/05/16
Ethics committee reference number
AJUMS.REC.1392.165
Health conditions studied
1
Description of health condition studied
Non alcoholic fatty liver
ICD-10 code
K76.0
ICD-10 code description
Non alcoholic fatty liver disease
Primary outcomes
1
Description
Nuclear factor-kappa B
Timepoint
Before intervention and 3 months after intervention
Method of measurement
ELISA
2
Description
Aspartate aminotransferase
Timepoint
Before intervention and 3 months after intervention
Method of measurement
ELISA
3
Description
High-sensitivity C-reactive Protein
Timepoint
Before intervention and 3 months after intervention
Method of measurement
ELISA
4
Description
Triglyciride
Timepoint
Before intervention, 3 month after intervention
Method of measurement
Photometric
5
Description
Malondialdehyde
Timepoint
Before intervention and 3 months after intervention
Method of measurement
ELISA
6
Description
Total antioxidant capacity
Timepoint
Before intervention and 3 months after intervention
Method of measurement
ELISA
7
Description
Alanine transaminase
Timepoint
Before intervention and 3 months after intervention
Method of measurement
ELISA
8
Description
VLDL
Timepoint
Before intervention and 3 month after intervention
Method of measurement
TG/5
9
Description
LDL-C
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Fridewald method
10
Description
Fasting blood sugar
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Photometric
11
Description
HDL-C
Timepoint
Before intervention and 3 month after intervention
Method of measurement
Enzymatic
Secondary outcomes
1
Description
Body weight
Timepoint
Before intervention and 3 month after intervention
Method of measurement
Digital scale
2
Description
Blood pressure
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Blood pressure monitor
3
Description
Body mass index
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Body weight in kilograms divided by height squared in meters
4
Description
Waist circumference
Timepoint
Before intervention and 3 month after intervention
Method of measurement
Meter
5
Description
Hip circumefrence
Timepoint
Before intervention and 3 month after intervention
Method of measurement
Meter
6
Description
Waist Hip Ratio
Timepoint
Before intervention and 3 month after intervention
Method of measurement
Waist circumference to hip Circumference ratio
Intervention groups
1
Description
Intervention group: daily consumption of 30 grams dark chocolate 83% (made by Iran Shirin Asal Company) for 3 months
Category
Treatment - Drugs
2
Description
Control group: without consuming dark chocolate for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Education and Treatment Center Emam Khomeini Hospital
Full name of responsible person
Dr Pezhman Alavi Nejad
Street address
Ahvaz, Azadegan alley
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Institute for Infectious Diseases of Digestive System, Ahvaz Jundi Shapur University of Med
Full name of responsible person
Dr Pezhman alavi Nejad
Street address
Research Institute for Infectious Diseases of Digestive System, Imam hospital, Azadegan street
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute for Infectious Diseases of Digestive System, Ahvaz Jundi Shapur University of Med
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Shirin Asal Co.
Full name of responsible person
MRS Jale
Street address
Kaj Square, Saadat Abad
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shirin Asal Co.
Proportion provided by this source
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
Research Institute for Infectious Diseases of Digestive System, Ahvaz Jundi Shapur University of Med
Full name of responsible person
Farnaz farsi
Position
MSc in nutrition
Other areas of specialty/work
Street address
Ahvaz, Azadegan alley
City
Ahvaz
Postal code
Phone
+98 61 1292 1839
Fax
Email
farnaz.farsi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research Institute for Infectious Diseases of Digestive System, Ahvaz Jundi Shapur University of Med
Full name of responsible person
Dr Pezhman Alavi Nejad
Position
Gastroenterologist, Assistant professor
Other areas of specialty/work
Street address
No. 16, 16th AVE., kianpars
City
Ahvaz
Postal code
6155873559
Phone
+98 61 1391 2533
Fax
Email
pezhmanalavinejad@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research Institute for Infectious Diseases of Digestive System, Ahvaz Jundi Shapur University of Med
Full name of responsible person
Farnaz farsi
Position
MSc in nutrition
Other areas of specialty/work
Street address
Ahvaz, Azadegan alley
City
Ahvaz
Postal code
Phone
+98 61 1292 1839
Fax
Email
farnaz.farsi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)