Protocol summary
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Study aim
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investigate the effect of Purslane seeds on anthropometric parameters, fas
ting blood glucose (FBS), insuline resistance, malon di aldehid, DPPH, lipid profile and liver enzymes in patients with nonalcoholic fatty livers.
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Design
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Two arm parallel group clinical randomised trial
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Settings and conduct
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this study was a randomized clinical trial involving 60 patients with NAFLD, who referred to Najaf Abad Teachers Clinics. Participants will be divided into 2 groups, control and intervention. At the beginning and at the end of the 8 th week of intervention, anthropometric parameters, three days food record, FBS, insulin resistance liver enzymes and liver sonography will studied in both groups
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Participants/Inclusion and exclusion criteria
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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; do not use low caloric diet or drugs for decrease weight in 3 months; 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.
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Intervention groups
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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) for 8 weeks. the patients in 2 groups will given a diet of 500 kcal energy less than their needs in termsbof their modified weights and a ratio of 30% fat, 15% protein, and 55% carbohydrate
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Main outcome variables
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FBS, Insulin resistance, HDL, TG, LDL, TOTAL Cholestorl, ALK, AST, ALT, MDA, DPPH And liver sonography
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2014090210826N14
Registration date:
2014-09-26, 1393/07/04
Registration timing:
registered_while_recruiting
Last update:
2018-11-10, 1397/08/19
Update count:
1
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Registration date
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2014-09-26, 1393/07/04
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Yazd Shahid Sadoghi University
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Expected recruitment start date
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2014-04-04, 1393/01/15
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Expected recruitment end date
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2014-12-21, 1393/09/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of Purslane seeds on liver enzymes, lipid profile and FBS in patients with nonalcoholic fatty liver disease
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Public title
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Effect of Purslane seeds in patients with nonalcoholic fatty liver disease
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Inclusion criteria: age between 25 to75 years old
body mass index>=25
distinction of the grade of fatty liver by sonography and understanding 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 supplements 2 months ago
do not change in drugs for reduce lipid and hypertension during the intervention
Exclusion criteria: patients who are not using more than 30 percent of determined Purslane seeds sachet will excluded from study.
Exclusion criteria:
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Age
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From 25 years old to 75 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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computerized genererated random number table
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2014-03-01, 1392/12/10
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Ethics committee reference number
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پ/17/1/241126
Health conditions studied
1
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Description of health condition studied
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Non alcoholic fatty liver
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ICD-10 code
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K76.O
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ICD-10 code description
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Nonalcoholic fatty liver disease (NAFLD)
Primary outcomes
1
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Description
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liver supersonic graphy
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Timepoint
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before & after intervention
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Method of measurement
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radiologic picture
2
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Description
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AST
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Timepoint
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before and after intervention
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Method of measurement
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blood sample
3
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Description
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ALT
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Timepoint
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before and after intervention
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Method of measurement
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blood sample
4
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Description
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Alkalin phosphat
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Timepoint
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before and after intervention
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Method of measurement
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blood sample
Secondary outcomes
1
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Description
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weight
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Timepoint
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before avd after intervention
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Method of measurement
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digital scale
2
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Description
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hieght
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Timepoint
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before avd after intervention
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Method of measurement
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stadiometer,m
3
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Description
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waist circumfrence
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Timepoint
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before avd after intervention
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Method of measurement
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meter,cm
4
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Description
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FBS
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Timepoint
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before and after intervention
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Method of measurement
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mg/dl
5
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Description
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Total cholestrol
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Timepoint
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before and after intervention
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Method of measurement
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mgr/dl, blood sample
6
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Description
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LDL
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Timepoint
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before and after intervention
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Method of measurement
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mgr/dl, blood sample
7
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Description
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HDL
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Timepoint
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before and after intervention
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Method of measurement
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mgr/dl, blood sample
8
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Description
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Triglycerid
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Timepoint
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before and after intervention
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Method of measurement
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mgr/dl, blood sample
9
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Description
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insulin
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Timepoint
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before and after intervention
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Method of measurement
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blood sample
10
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Description
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malon di aldehid
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Timepoint
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before and after intervention
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Method of measurement
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blood sample
11
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Description
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DPPH
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Timepoint
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before and after intervention
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Method of measurement
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blood sample
Intervention groups
1
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Description
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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.
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Category
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Other
2
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Description
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Control group: using low caloric diet (kilo caloric/ body weight) - 500. 15% protein, 55% carbohydrate, 30% fat.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Research deputy, Shahid Sadoughi University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Data report will be shared after publishing the paper
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When the data will become available and for how long
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Six months after publish
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To whom data/document is available
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Academic researchers
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Under which criteria data/document could be used
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Using for Meta-analysis
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From where data/document is obtainable
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Center nutrition, public health, univercity of medical sciencies yazd Tel: 009835 31492239 Email: azadehnajarzadeh@gmail.com Azadenadjarzadeh
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What processes are involved for a request to access data/document
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It will be sent two weeks after the receipt of the email with the consent of the co-workers
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Comments
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