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The aim of this study is to determining of the effects of Eicosapentaenoic acid (EPA) supplementation on serum activities of Paraoxonase-1 and Homocystein thiolactonase, and serum levels of some indicators of vascular inflammation, and the gene expression of PON2 in the peripheral blood mononuclear cell (PBMC) in the patients with type II diabetes mellitus.
The aim of this study is to determining of the effects of Eicosapentaenoic acid (EPA) supplementation on serum activities of Paraoxonase-1 and Homocystein thiolactonase and several indicators of vascular inflammation and the gene expression of PON2 in the peripheral blood mononuclear cell (PBMC) in the patients with type II diabetes mellitus. In this randomized, double-blind clinical trial, placebo-controlled, single-center, 36 men and women aged 35-50 years with type 2 diabetes are enrolled in the study from the Iranian Diabetes Association. After signing informed consent, all individuals complete a general information form. a 24-hour food recall for 3 days will be taken from the participants at the beginning and the end of the study,. Selected samples are randomly classified into 2 blocks of groups receiving supplement and placebo. Two groups will be classified (blocked) based on sex. The supplement group, will receive 2 g/day EPA for 8 weeks and the placebo group will also receive placebo (containing 2 g of edible paraffin) (similar in terms of color, shape and size). Patients are recommended to sustain their diets and medication dose (s) during the study and also advised to maintain a constant level of physical activity. Blood samples will be collected after 8-12 hours fasting and anthropocentric variables, biochemical parameters, target gene expression and physical activity before and after the trial will be measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EPA placebo | Placebo Comparator | EPA- placebo softgel (Containing 2 g edible paraffin oil), 2 times/day, for 8 weeks |
|
| EPA supplement | Active Comparator | EPA supplement softgel (containing 2 g EPA per day), 2 times/day, for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPA Supplement | Dietary Supplement | EPA supplement, 4 × 500 mg softgel daily (2 g per day), 2 times a day, for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Hemoglobin A1c (HbA1c) measurement by related kits according their protocols | Change from Baseline at 8 weeks after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| PON2 gene expression | measurement of paraoxonase-2(PON-2) gene expression using quantitative Real-time PCR | Baseline, 8 weeks after the intervention |
| Systolic blood pressure | Systolic blood pressure changes measurement by manometer |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammad Hassan Golzari, Ph.D | Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS) | Principal Investigator |
| Mahmoud Djallali, Ph.D | Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS) | Study Chair |
| Saeed Hosseini, MD,Ph.D | Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tehran University of Medical Sciences (TUMS), School of Nutritional Sciences and Dietetics, Department of Cellular and Molecular Nutrition | Tehran | 1471613151 | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30746344 | Derived | Golzari MH, Javanbakht MH, Ghaedi E, Mohammadi H, Djalali M. Effect of Eicosapentaenoic Acid Supplementation on Paraoxonase 2 Gene Expression in Patients with Type 2 Diabetes Mellitus: a Randomized Double-blind Clinical Trial. Clin Nutr Res. 2019 Jan 28;8(1):17-27. doi: 10.7762/cnr.2019.8.1.17. eCollection 2019 Jan. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015118 | Eicosapentaenoic Acid |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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| EPA Placebo | Dietary Supplement | EPA- placebo softgel (Containing 2 g edible paraffin oil), 4 × 500 mg softgel daily, 2 times a day, for 8 weeks. |
|
| Change frome baseline at 8 weeks |
| Diastolic blood pressure | Diastolic blood pressure changes measurement by manometer | Change frome baseline at 8 weeks |
| serum paraoxonase-1(PON-1) activity | serum paraoxonase-1(PON-1) activity by kit according related protocol | Baseline, 8 weeks after the intervention |
| PON1/HDL-c Ratio | calculating the ratio after measurement of PON1 and HDL-c by related kits according their protocols | Baseline, 8 weeks after the intervention |
| serum paraoxonase lactonase (PON-HCTLase) activity | measurement of paraoxonase lactonase (PON-HCTLase) activity by related kit according its protocol | Baseline, 8 weeks after the intervention |
| HDL-c | high density lipoprotein- cholesterol (HDL-c) measurement by related kits according their protocols | Baseline, 8 weeks after the intervention |
| FBS | Fasting blood sugar (FBS) measurement by related kits according their protocols | Baseline, 8 weeks after the intervention |
| HDL2-c | high density lipoprotein 2- cholesterol (HDL2-c) measurement by related kits according their protocols | Baseline, 8 weeks after the intervention |
| HDL3-c | high density lipoprotein 3- cholesterol (HDL3-c) measurement by related kits according their protocols | Baseline, 8 weeks after the intervention |
| Serum apo B | Serum apo-protein B measurement by related kits according their protocols | Baseline, 8 weeks after the intervention |
| Serum apo A-I | Serum apo-protein A-I measurement by related kits according their protocols | Baseline, 8 weeks after the intervention |
| apo B/apo A-I Ratio | calculating the ratio after measurement of apo B and apo A-1 by related kits according their protocols | Baseline, 8 weeks after the intervention |
| Serum methionine | measurement of serum levels of methionine by related kit according its protocol | Baseline, 8 weeks after the intervention |
| Serum malondialdehyde (MDA) | measurement of serum levels of malondialdehyde (MDA)by related kit according its protocol | Baseline, 8 weeks after the intervention |
| Serum homocysteine (Hcy) | measurement of serum levels of homocysteine (Hcy) by related kit according its protocol | Baseline, 8 weeks after the intervention |
| Serum sE-Selectin | measurement of serum levels of soluble E-Selectin by related kit according its protocol | Baseline, 8 weeks after the intervention |
| sVCAM-1 | measurement of serum levels of soluble Vascular cell adhesion molecule-1 (VCAM-1) by related kit according its protocol | Baseline, 8 weeks after the intervention |
| Serum cysteine | measurement of serum levels of cysteine by related kit according its protocol | Baseline, 8 weeks after the intervention |
| Serum Lpa | measurement of serum levels of lipoprotein-a (Lpa)by related kit according its protocol | Baseline, 8 weeks after the intervention |
| D004700 | Endocrine System Diseases |
| D008055 |
| Lipids |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |