| Trial ID: | L0851 |
| Source ID: | IRCT201511233664N16
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| Associated Drug: |
Resveratrol
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| Title: |
Comparison of resveratrol supplementation, calorie restriction diet and placebo on nutritional status, metabolic and oxidative parameters, serum sirtuin-1 and fibroblast growth factor-21 levels in patients with nonalcoholic fatty liver disease
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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: |
nonalcoholic fatty liver disease. <br>Fatty (change of) liver, not elsewhere classified;Fatty (change of) liver, not elsewhere classified
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| Interventions: |
Intervention 1: Intervention1: calorie restriction diet for 3 months. Intervention 2: Intervention 2: 2 capsules daily each contains 300 mg of trans resveratrol for 3 months. Intervention 3: placebo: 2 capsules daily each contains 300 mg of starch for 3
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| Outcome Measures: |
Liver echogenicity. Timepoint: Baseline and after the intervention. Method of measurement: Sonographic findings.;Lipid profile (TC, TG, LDL-C, HDL-C, APO-A1, APO-B). Timepoint: Baseline and after the intervention. Method of measurement: Biochemical.;Fasting blood glucose. Timepoint: Baseline and after the intervention. Method of measurement: Biochemical.;Insulin. Timepoint: Baseline and after the intervention. Method of measurement: ELISA.;Insulin resistance. Timepoint: Baseline and after the intervention. Method of measurement: HOMA-IR.;Oxidative status (TAC, MDA, GPx, SOD, Ox-LDL). Timepoint: Baseline and after the intervention. Method of measurement: Biochemical.;Sirtuin-1. Timepoint: Baseline and after the intervention. Method of measurement: ELISA.;Fibroblast growth factor-21. Timepoint: Baseline and after the intervention. Method of measurement: ELISA.;Added at 2016-11-15: Plasminogen activator inhibitor-1 (PAI-1. Timepoint: Added at 2016-11-15: Baseline and after the intervention. Method of measurement: Added at 2016-11-15: ELISA.;Added at 2016-11-15: hs-CRP. Timepoint: Added at 2016-11-15: Baseline and after the intervention. Method of measurement: Added at 2016-11-15: Imonotorbidometry.;Liver enzymes (ALT, AST, GGT, ALP). Timepoint: Baseline and after the intervention. Method of measurement: Spectrophotometry.Systolic and diastolic blood pressure. Timepoint: Baseline and after the intervention. Method of measurement: Manometer.;Anthropometric measurements (BMI, WHR, WC). Timepoint: Baseline and after the intervention. Method of measurement: Secca scale, non stretch meter.;Energy and nutrient intake. Timepoint: Baseline, end of week 6 and after the intervention. Method of measurement: 3-day food record questionnaire.
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| Sponsor/Collaborators: |
Nutrition Research Center, vice-chancellor of Tabriz University of Medical Sciences
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| Gender: |
All
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| Age: |
18 years60 years
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| Phases: |
Phase 2/Phase 3
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| Enrollment: |
87
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| Study Type: |
interventional
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| Study Designs: |
Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: This study is partially blinded. The intervention for resveratrol and placebo groups is indistinguishable for study subje
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| Start Date: |
08/02/2016
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
22 February 2018
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| Locations: |
Iran (Islamic Republic of)
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| URL: |
http://en.irct.ir/trial/3760
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