| Trial ID: | L0715 |
| Source ID: | IRCT20150205020965N4
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| Associated Drug: |
Camelina oil
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| Title: |
The effect of Camelina oil with and without Resistant dextrin supplementation on metabolic, inflammatory and anti-inflammatory markers in patients with Non-alcoholic fatty liver
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| Acronym: |
--
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| Status: |
Not Recruiting
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| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
Non-alcoholic fatty liver. <br>Fatty (change of) liver, not elsewhere classified;K76.0
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| Interventions: |
Intervention 1: In this study, Camelina oil will be replaced with 15% of the daily total fat intake and patients will receive two of 5-mg dextrin-resistant doses every day for three months. Then, 15 days before the beginning of study, FFQ questionnaire wi
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| 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: sonography.;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: calculation.;Insulin Resistance Index (HOMA-IR). Timepoint: At baseline and three months after baseline. Method of measurement: calculation.;Fasting insulin. Timepoint: At baseline and three months after baseline. Method of measurement: kit.;Total -cholesterol. 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.;Triglyceride. Timepoint: At baseline and three months after baseline. Method of measurement: Autoanalyzer - Hitachi 911.;Highly sensitive C-reactive protein(hs-CRP ). Timepoint: At baseline and three months after baseline. Method of measurement: Kit.;Tumor Necrosis Factor (TNF). Timepoint: At baseline and three months after baseline. Method of measurement: ELISA Kit.;Interleukin 10(IL10 ). Timepoint: At baseline and three months after baseline. Method of measurement: ELISA 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.;8-iso-prostaglandin F2a (8-iso-PGF2a). 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.;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.;PPAR-a expression. Timepoint: At baseline and three months after baseline. Method of measurement: kit.;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.;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.;Il17. Timepoint: At baseline and three months after baseline. Method of measurement: kit.;PPAR-a expression. Timepoint: At baseline and three months after baseline. Method of measurement: pcr.Body Mass Index (BMI). Timepoint: At baseline and three months after baseline. Method of measurement: Calculation.;Amount of received energy. Timepoint: At baseline and three months after baseline. Method of measurement: Questionnaire.;Daily carbohydrate intake. Timepoint: At baseline and three months after baseline. Method of measurement: Questionnaire.;Daily protein intake. Timepoint: At baseline and three months after baseline. Method of measurement: Questionnaire.;Daily fat intake. Timepoint: At baseline and three months after baseline. Method of measurement: Questionnaire.;Daily fiber intake. Timepoint: At baseline and three months after baseline. Method of measurement: Questionnaire.;Weight. Timepoint: At baseline and three months after baseline. Method of measurement: Scale.;Waist circumference (WC). Timepoint: At baseline and three months after baseline. Method of measurement: Tape.;Hip circumference (HC). Timepoint: At baseline and three months after baseline. Method of measurement: Tape.;Waist circumference (WHR) ________________________________________. Timepoint: At baseline and three months after baseline. Method of measurement: Calculation.;Blood pressure. Timepoint: At baseline and three months after baseline. Method of measurement: Mercury barometer.;Body composition. Timepoint: At baseline and three months after baseline. Method of measurement: BIA devices.
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| Sponsor/Collaborators: |
Tabriz University of Medical Sciences
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| Gender: |
All
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| Age: |
20 years65 years
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| Phases: |
Phase 3
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| Enrollment: |
32
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| Study Type: |
interventional
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| Study Designs: |
Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: At baseline, eligible individuals will be matched for BMI, age, and sex according to the classification of these varia
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| Start Date: |
13/12/2019
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
6 October 2020
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| Locations: |
Iran (Islamic Republic of)
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| URL: |
http://en.irct.ir/trial/43183
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