| Trial ID: | L0839 |
| Source ID: | IRCT2016082429508N1
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| Associated Drug: |
DHA
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| Title: |
The effect of a hypocaloric diet and omega-3 fatty acid supplementation on serum levels of liver enzymes, lipid profile and insulin resistance in overweight and obese patients with non-alcoholic 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: |
Non-alcoholic 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: First intervention group: Thirty eight patients with Nafld will receive a hypocaloric diet program consisting of 50% carbohydrates, 20% protein and 30% fat with a goal of 5% weight reduction. Dietary intake will assess by 24-hour recall me
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| Outcome Measures: |
Fasting blood sugar. Timepoint: At baseline and after 3 month. Method of measurement: measured in milligram per deciliter, using colorimetry method.;Fasting insulin. Timepoint: At baseline and after 3 month. Method of measurement: measured in microUnit/milliliter, using Elisa.;HOMA-IR. Timepoint: At baseline and after 3 month. Method of measurement: using formula.;High density lipoprotein (HDL-C). Timepoint: At baseline and after 3 month. Method of measurement: measured in milligram per deciliter, using colorimetry method.;Low density lipoprotein (LDL-C). Timepoint: At baseline and after 3 month. Method of measurement: measured in milligram per deciliter, using colorimetry method.;Total cholesterol. Timepoint: At baseline and after 3 month. Method of measurement: measured in milligram per deciliter, using colorimetry method.;Triglyceride. Timepoint: At baseline and after 3 month. Method of measurement: measured in milligram per deciliter, using colorimetry method.;Alanine aminotransferase (ALT). Timepoint: At baseline and after 3 month. Method of measurement: measured in international units/liter, using colorimetry method.;Aspartate aminotransferase (AST). Timepoint: At baseline and after 3 month. Method of measurement: measured in international units/liter, using colorimetry method.;Weight. Timepoint: At baseline and after 3 month. Method of measurement: measured in kilograms, using digital scale.;Waist circumference. Timepoint: At baseline and after 3 month. Method of measurement: measured in centimeter, using a soft tape.;Body mass index. Timepoint: At baseline and after 3 month. Method of measurement: kg/m2, using standard formula.;Height. Timepoint: At baseline and after 3 month. Method of measurement: measured in meter, using mounted tape.Physical activity level. Timepoint: At baseline and after 3 month. Method of measurement: international physical activity questionnaire short form (IPAQ-SF).
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| Sponsor/Collaborators: |
Vice chancellor for research, Urmia University of Medical Sciences
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| Gender: |
All
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| Age: |
18 years65 years
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| Phases: |
Phase 2
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| Enrollment: |
114
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| Study Type: |
interventional
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| Study Designs: |
Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.
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| Start Date: |
20/09/2016
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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/23698
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