| Trial ID: | L0714 |
| Source ID: | IRCT20150205020965N5
|
| Associated Drug: |
Camelina oil
|
| Title: |
Comparison of the effects of Camelina and Sunflower oils on metabolic, inflammatory and anti-inflammatory factors in patients with Non-alcoholic fatty liver
|
| Acronym: |
--
|
| Status: |
Not Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-alcoholic fatty liver. <br>Fatty (change of) liver, not elsewhere classified;k76.0
|
| Interventions: |
Intervention 1: 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 c
|
| Outcome Measures: |
ALT. Timepoint: At baseline and three months after baseline. Method of measurement: Hitachi 911 auto-analyzer.;AST. Timepoint: At baseline and three months after baseline. Method of measurement: Hitachi 911 auto-analyzer.;ALP. Timepoint: At baseline and three months after baseline. Method of measurement: Hitachi 911 auto-analyzer.;Degree of hepatic steatosis. Timepoint: At baseline and three months after baseline. Method of measurement: Ultrasound.;Fasting glucose. Timepoint: At baseline and three months after baseline. Method of measurement: Hitachi 911 auto-analyzer.;Insulin Sensitivity Index (QUICK). Timepoint: At baseline and three months after baseline. Method of measurement: Computing.;Insulin Resistance Index (HOMA-IR). Timepoint: At baseline and three months after baseline. Method of measurement: Computing.;Fasting insulin. Timepoint: At baseline and three months after baseline. Method of measurement: Chemoluminescense.;Total cholestrol. Timepoint: At baseline and three months after baseline. Method of measurement: Hitachi 911 auto-analyzer.;HDL-cholesterol. Timepoint: At baseline and three months after baseline. Method of measurement: Hitachi 911 auto-analyzer.;LDL-cholesterol. Timepoint: At baseline and three months after baseline. Method of measurement: calculation of LDL using friedewald equation.;Triglyceride. Timepoint: At baseline and three months after baseline. Method of measurement: Hitachi 911 auto-analyzer.;Highly sensitive C-reactive protein(hs-CRP ). Timepoint: At baseline and three months after baseline. Method of measurement: ELISA Dedicated Kit.;Tumor Necrosis Factor(TNF). Timepoint: At baseline and three months after baseline. Method of measurement: ELISA Dedicated Kit.;Interleukin 10(IL10 ). Timepoint: At baseline and three months after baseline. Method of measurement: ELISA Dedicated Kit.;Total antioxidant capacity. Timepoint: At baseline and three months after baseline. Method of measurement: kit.;Malondialdehyde. Timepoint: At baseline and three months after baseline. Method of measurement: kit.;Superoxide dismutase. Timepoint: At baseline and three months after baseline. Method of measurement: kit.;Glutathione peroxidase. Timepoint: At baseline and three months after baseline. Method of measurement: kit.;8-iso-prostaglandin F2a (8-iso-PGF2a). Timepoint: At baseline and three months after baseline. Method of measurement: kit.;Leptin. Timepoint: At baseline and three months after baseline. Method of measurement: kit.;Adiponectin. Timepoint: At baseline and three months after baseline. Method of measurement: kit.;Ghrelin. Timepoint: At baseline and three months after baseline. Method of measurement: kit.;Appetite status. Timepoint: At baseline and three months after baseline. Method of measurement: questionnaire.;PPAR-a expression. Timepoint: At baseline and three months after baseline. Method of measurement: pcr.;Mental health. Timepoint: At baseline and three months after baseline. Method of measurement: questionnaires.;Lipopolysaccharide. Timepoint: At baseline and three months after baseline. Method of measurement: kit.;Cd4. Timepoint: At baseline and three months after baseline. Method of measurement: kit.;IL17. Timepoint: At baseline and three months after baseline. Method of measurement: kit.;Cd8. Timepoint: At baseline and three months after baseline. Method of measurement: kit.;ILB1. Timepoint: At baseline and three months after baseline. Method of measurement: kit.;Brain-derived Neurotrophic Factor. Timepoint: At baseline and three months after baseline. Method of measurement: kit.Body Mass Index (BMI). Timepoint: At baseline and three months after baseline. Method of measurement: Scale-Meter.;Amount of received energy. Timepoint: At baseline and three months after baseline. Method of measurement: questionnaire.;Daily macronutrient intake (carbohydrate, protein, fat). Timepoint: At baseline and three months after baseline. Method of measurement: questionnaire.;Waist circumference (WHR). Timepoint: At baseline and three months after baseline. Method of measurement: Calculate by splitting waist to hip.;Blood pressure. Timepoint: At baseline and three months after baseline. Method of measurement: Mercuric barometr.;Assessment of the body composition. Timepoint: At baseline and three months after baseline. Method of measurement: BIA devices.
|
| Sponsor/Collaborators: |
Tabriz University of Medical Sciences
|
| Gender: |
All
|
| Age: |
20 years65 years
|
| Phases: |
Phase 3
|
| Enrollment: |
46
|
| Study Type: |
interventional
|
| Study Designs: |
Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Classification of these variables will be used to match them in BMI, age and sex. All of the 23 patients will be rando
|
| Start Date: |
13/12/2019
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
17 August 2020
|
| Locations: |
Iran (Islamic Republic of)
|
| URL: |
http://en.irct.ir/trial/43187
|
