In this clinical trial, 60 volunteers who have nonalcoholic fatty liver disease will participate. Participants will be divided into 2 groups, control and intervention. The intervention group will asked to use 10 milligrams of purslane seeds (5 milligrams of purslane seeds before the breakfast and dinner). Before and after the intervention, biochemical tests such as LDL, HDL, TG, Total Chol, FBS, AST, ALT, ALP and ultra sonography will be taken. The height, weight, waist and hip circumference and blood pressure will be measured, too. Participants will be asked not to change their physical activity, diet and drugs used during the intervention. Three days food record will be taken before the study. Every 7 days we will follow them by phone calls or visitation. Intervention group and control group use diet. Patients will follow up for 8 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014090210826N14
Registration date:2014-09-26, 1393/07/04
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2014-09-26, 1393/07/04
Registrant information
Name
Azadeh Nadjarzadeh
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 202 2817
Email address
azadnajarzadeh@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd Shahid Sadoghi University
Expected recruitment start date
2014-04-04, 1393/01/15
Expected recruitment end date
2014-12-21, 1393/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Purslane seeds on liver enzymes, lipid profile and FBS in patients with nonalcoholic fatty liver disease
Public title
Effect of Purslane seeds in patients with nonalcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 25 to75 years old; body mass index>=25; distinction of the grade of fatty liver by sonography and undrestanding by doctor; not pregnant or lactating; do not have any other diseases like gastrointestinal, liver, renal or thyroid disease and diabetes; individuals who are not under special diet and do not participate in another intervention; do not use low caloric diet or drugs for decrease weight in 3 months; do not use vitamin suplement 2 months ago; do not change in drugs for reduce lipid and hypertension during the intervention. Exclusion criteria: patients that without using 70 percent of determined Purslane seeds will exclude from study.
Age
From 25 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Science
Street address
Yazd, Imam Hosein Square
City
yazd
Postal code
Approval date
2014-03-01, 1392/12/10
Ethics committee reference number
پ/17/1/241126
Health conditions studied
1
Description of health condition studied
Non alcoholic fatty liver
ICD-10 code
K76.O
ICD-10 code description
Nonalcoholic fatty liver disease (NAFLD)
Primary outcomes
1
Description
liver supersonic graphy
Timepoint
before & after intervention
Method of measurement
radiologic picture
2
Description
AST
Timepoint
before and after intervention
Method of measurement
blood sample
3
Description
ALT
Timepoint
before and after intervention
Method of measurement
blood sample
4
Description
Alkalin phosphat
Timepoint
before and after intervention
Method of measurement
blood sample
Secondary outcomes
1
Description
weight
Timepoint
before avd after intervention
Method of measurement
digital scale
2
Description
hieght
Timepoint
before avd after intervention
Method of measurement
stadiometer,m
3
Description
waist circumfrence
Timepoint
before avd after intervention
Method of measurement
meter,cm
4
Description
FBS
Timepoint
before avd after intervention
Method of measurement
mg/dl
5
Description
Total cholestrol
Timepoint
before avd after intervention
Method of measurement
mgr/dl, blood sample
6
Description
LDL
Timepoint
before avd after intervention
Method of measurement
mgr/dl, blood sample
7
Description
HDL
Timepoint
before avd after intervention
Method of measurement
mgr/dl, blood sample
8
Description
Triglycerid
Timepoint
before avd after intervention
Method of measurement
mgr/dl, blood sample
Intervention groups
1
Description
Intervention group: using low caloric diet (kilo caloric/ body weight) - 500.15% protein, 55% carbohydrate, 30% fat.also they use10 gr purslane seed daily for 8 weeks.
Category
Other
2
Description
Control group: using low caloric diet (kilo caloric/ body weight) - 500. 15% protein, 55% carbohydrate, 30% fat.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farhangian cilinic
Full name of responsible person
Street address
City
Najaf abad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
research deputy, shahid saddughi university of medical sciences
Full name of responsible person
Dr Hassan Mozaffari
Street address
Bahonar square, yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
research deputy, shahid saddughi 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
Yazd University of Medical Sciences
Full name of responsible person
Dr Azade Najarzadeh
Position
PhD of Nutrition
Other areas of specialty/work
Street address
Shahid Saddughi University, Yazd
City
Yazd
Postal code
Phone
+98 35 1624 0696
Fax
Email
azadnajarzadeh@ssu.ac.ir; azmm1383@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Azade Najarzade
Position
Yazd University of Medical Sciences
Other areas of specialty/work
Street address
Shahid Saddughi University, Yazd
City
Yazd
Postal code
Phone
+98 35 1624 0696
Fax
Email
azadnajarzadeh@ssu.ac.ir; azmm1383@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Elham Adelnia
Position
Master student of nutritionn
Other areas of specialty/work
Street address
Yazd University of Medical Sciences. Yazd
City
Yazd
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)