Protocol summary
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Study aim
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Comparison of the effects of Camelina and Sunflower oils on metabolic, inflammatory and anti-inflammatory factors in patients with Non-alcoholic fatty liver
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Design
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In this study, the target population will be those with NAFLD, who were included by a gastroenterologist with ultrasound examination based on inclusion criteria. After obtaining written consent the target population will be divided into camelina and Or the sunflower oil groups randomly. 15% of the total 30% of dietary fat should be allocated to mentioned oils.
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Settings and conduct
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This three-blind study is carried out at the Faculty of Nutrition, Tabriz University of Medical Sciences
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Participants/Inclusion and exclusion criteria
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Patients with NAFLD and lack of inclusion criteria (having other liver disease apart from NAFLD, liver transplant, pregnancy and lactation)
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Intervention groups
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Intervention (recipient of weight reduction diet + camelina oil) control (recipient of weight reduction diet + sunflower oil)
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Main outcome variables
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En Alanine amino transferase (ALT); aspartate amino transferase (AST); alkaline phosphatase (ALP); Degree of hepatic steatosis; fasting blood glucose; fasting insulin; insulin resistance; insulin sensitivity; total cholesterol (TC); low triglyceride High density lipoprotein (HDL); tumor necrosis factor-alpha (TNF-α); high-sensitivity c-reactive protein (Hs-CRP); interleukin-10 (IL-10)
General information
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Reason for update
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According to the comprehensive review on registered trial, all the added parameters along with the recorded parameters were presented as a comprehensive study in this field. Unfortunately, before registering this project in the Iranian Registry of Clinical Trials due to financial constraints, some of the considered parameters were removed. Recently, due to the funding of the project via top researchers grant, researchers have re-added the deleted parameters to the project for a comprehensive study in this field.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20150205020965N5
Registration date:
2019-12-13, 1398/09/22
Registration timing:
registered_while_recruiting
Last update:
2020-08-01, 1399/05/11
Update count:
1
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Registration date
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2019-12-13, 1398/09/22
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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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Expected recruitment start date
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2019-11-20, 1398/08/29
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Expected recruitment end date
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2020-05-18, 1399/02/29
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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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Comparison of the effects of Camelina and Sunflower oils on metabolic, inflammatory and anti-inflammatory factors in patients with Non-alcoholic fatty liver
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Public title
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The effect of camelina oil in patients with nonalcoholic fatty liver
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age range 20 to 65 years
BMI≥25
No weight changes over the past 3 months
Restricted Consumption of edible nuts and fish
Tendency to use camelina oil
Having grade 1 and 2 of non-alcoholic fatty liver disease
Exclusion criteria:
Having other liver disease apart from NAFLD (alcoholic fatty liver, viral hepatitis, cirrhosis and biliary obstruction, liver cancer))
Liver transplantation
Pregnancy and Lactation
Kidney, Cardiovascular Disease
Alcohol and tobacco consumption
high physical activity
having acute illness
Use of drugs such as glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDS), hepatotoxic drugs, antibiotics
Use antioxidant supplements and W3
history of using weight loss diet or a special diet over the past 6 months
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Age
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From 20 years old to 65 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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- Participant
- Investigator
- Data analyser
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Sample size
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Target sample size:
46
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Classification of these variables will be used to match them in BMI, age and sex. All of the 23 patients will be randomly divided into two groups including intervention (Weight loss diet+ Camelina oil ) and control (Weight loss diet + Sunflower oil) by using RAS software which is dividing patients to 2 and 4 blocks, 1 and 2 codes will be given them respectively too.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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After randomizing, the same weight loss diets with similar recommendations will be given by a dietitian to both groups.Both oils will be packaged in similar 900 grams opaque containers, without the researcher intervention and will be coding (1 and 2). The dietitian will introduce the oils by codes to patients.Until the reporting the results patient, researcher and analyser will not be aware of the codes. After the end of research, decodation will be done. So the study will be Triple-Blind.
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Placebo
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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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2019-10-20, 1398/07/28
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Ethics committee reference number
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IR.TBZMED.REC.1398.743
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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k76.0
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ICD-10 code description
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Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
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Description
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ALT
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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Hitachi 911 auto-analyzer
2
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Description
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AST
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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Hitachi 911 auto-analyzer
3
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Description
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ALP
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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Hitachi 911 auto-analyzer
4
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Description
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Degree of hepatic steatosis
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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Ultrasound
5
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Description
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Fasting glucose
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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Hitachi 911 auto-analyzer
6
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Description
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Insulin Sensitivity Index (QUICK)
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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Computing
7
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Description
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Insulin Resistance Index (HOMA-IR)
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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Computing
8
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Description
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Fasting insulin
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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Chemoluminescense
9
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Description
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Total cholestrol
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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Hitachi 911 auto-analyzer
10
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Description
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HDL-cholesterol
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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Hitachi 911 auto-analyzer
11
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Description
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LDL-cholesterol
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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calculation of LDL using friedewald equation
12
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Description
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Triglyceride
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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Hitachi 911 auto-analyzer
13
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Description
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Highly sensitive C-reactive protein(hs-CRP )
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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ELISA Dedicated Kit
14
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Description
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Tumor Necrosis Factor(TNF)
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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ELISA Dedicated Kit
15
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Description
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Interleukin 10(IL10 )
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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ELISA Dedicated Kit
16
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Description
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Total antioxidant capacity
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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kit
17
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Description
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Malondialdehyde
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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kit
18
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Description
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superoxide dismutase
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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kit
19
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Description
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Glutathione peroxidase
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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kit
20
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Description
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8-iso-prostaglandin F2α (8-iso-PGF2α)
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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kit
21
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Description
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leptin
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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kit
22
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Description
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adiponectin
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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kit
23
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Description
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ghrelin
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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kit
24
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Description
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Appetite status
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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questionnaire
25
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Description
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PPAR-α expression
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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pcr
26
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Description
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mental health
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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questionnaires
27
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Description
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lipopolysaccharide
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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kit
28
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Description
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cd4
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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kit
29
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Description
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IL17
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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kit
30
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Description
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cd8
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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kit
31
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Description
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ILB1
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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kit
32
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Description
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Brain-derived Neurotrophic Factor
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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kit
Secondary outcomes
1
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Description
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Body Mass Index (BMI)
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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Scale-Meter
2
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Description
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Amount of received energy
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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questionnaire
3
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Description
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Daily macronutrient intake (carbohydrate, protein, fat)
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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questionnaire
4
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Description
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Waist circumference (WHR)
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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Calculate by splitting waist to hip
5
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Description
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blood pressure
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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Mercuric barometr
6
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Description
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Assessment of the body composition
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Timepoint
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At baseline and three months after baseline
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Method of measurement
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BIA devices
Intervention groups
1
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Description
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In this study, Camelina oil will be replaced with 15% of the daily total fat intake for three months. Then, 15 days before the beginning of study, FFQ questionnaire will be completed for selected patients based on inclusion and exclusion criteria to determine the dietary pattern of patients. Patients will also be asked not to use omega-3 oils (as mentioned in list), during this time. Then, basal energy expenditure of each person will be calculated by Mifflin equation based on their weight, age, sex and total energy expenditure will be calculated according to the person's daily physical activity. For losing weight, 500 kcal reduction of total energy expenditure will be done, and then macronutrients will be distributed to 50% carbohydrate, 30% fat, 20% protein, and the proper diet will be adjusted according to one's dietary pattern. 15% of the dietary fat will be provide by Camelina oil (prepared by cold press, rich in omega-3 fatty acids, then will be analyzed before intervention). Patients will be instructed to measure the recommended amount of oil with the modules given with the oil, and add it to their salad or meal every day (while consuming or cooking), and intake the remain amount from dairy fat, meat and other oils. The oils will be given monthly to patients, and they will be advised to keep the consuming oil inside the refrigerator, depending on the type of processing (cold press). Each week a phone call will be made to ensure adherence to the diet, oil intake, and patient status assessment will be done. Patients will be asked to deliver the remaining oil bottles each month to receive the new oil bottles for the following month to ensure consumption and following them up. Patients will be advised to avoid fried foods, simple carbohydrates, solid oils and will be advised to use steamed foods as much as possible. Patients will be asked to report any gastrointestinal problems or not possibility of oil intake to available numbers. Metabolic, biochemical, anthropometric parameters, blood pressure and dietary intakes will be assessed before and after intervention.
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Category
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Treatment - Drugs
2
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Description
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In this study, Sunflower oil will be replaced with 15% of the daily total fat intake for three months. Then, 15 days before the beginning of study, FFQ questionnaire will be completed for selected patients based on inclusion and exclusion criteria to determine the dietary pattern of patients. Patients will also be asked not to use omega-3 oils (as mentioned in list), during this time. Then, basal energy expenditure of each person will be calculated by Mifflin equation based on their weight, age, sex and total energy expenditure will be calculated according to the person's daily physical activity. For losing weight, 500 kcal reduction of total energy expenditure will be done, and then macronutrients will be distributed to 50% carbohydrate, 30% fat, 20% protein, and the proper diet will be adjusted according to one's dietary pattern. 15% of the dietary fat will be provide by Sunflower oil (prepared by cold press, rich in omega-3 fatty acids, then will be analyzed before intervention). Patients will be instructed to measure the recommended amount of oil with the modules given with the oil, and add it to their salad or meal every day (while consuming or cooking), and intake the remain amount from dairy fat, meat and other oils. The oils will be given monthly to patients, and they will be advised to keep the consuming oil inside the refrigerator, depending on the type of processing (cold press). Each week a phone call will be made to ensure adherence to the diet, oil intake, and patient status assessment will be done. Patients will be asked to deliver the remaining oil bottles each month to receive the new oil bottles for the following month to ensure consumption and following them up. Patients will be advised to avoid fried foods, simple carbohydrates, solid oils and will be advised to use steamed foods as much as possible. Patients will be asked to report any gastrointestinal problems or not possibility of oil intake to available numbers. Metabolic, biochemical, anthropometric parameters, blood pressure and dietary intakes will be assessed before and after intervention.
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Category
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Placebo
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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Tabriz 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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Reporting the results
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When the data will become available and for how long
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After finishing and publishing the project articles
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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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With the permission of the project researcher and the project sponsoring organization - University of Nutrition Research and Research Deputy
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From where data/document is obtainable
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Dr. Parvin Dehghan, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences Email:Dehghan.nut@gmail.com +98 914 471 0299
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What processes are involved for a request to access data/document
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The applicator can send a request to the person responsible for the study by email.
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Comments
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