EPA Supplementation on Vascular Inflammation, and Gene Expression of PON2 in Patients With Type II Diabetes Mellitus

NCT ID: NCT03258840

Last Updated: 2017-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-08-31

Brief Summary

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.

Detailed Description

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.

Conditions

Diabetes Mellitus Type II

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

EPA placebo

EPA- placebo softgel (Containing 2 g edible paraffin oil), 2 times/day, for 8 weeks

Group Type: PLACEBO_COMPARATOR

EPA Placebo

Intervention Type: DIETARY_SUPPLEMENT

EPA- placebo softgel (Containing 2 g edible paraffin oil), 4 × 500 mg softgel daily, 2 times a day, for 8 weeks.

EPA supplement

EPA supplement softgel (containing 2 g EPA per day), 2 times/day, for 8 weeks.

Group Type: ACTIVE_COMPARATOR

EPA Supplement

Intervention Type: DIETARY_SUPPLEMENT

EPA supplement, 4 × 500 mg softgel daily (2 g per day), 2 times a day, for 8 weeks.

Interventions

EPA Supplement

EPA supplement, 4 × 500 mg softgel daily (2 g per day), 2 times a day, for 8 weeks.

Intervention Type: DIETARY_SUPPLEMENT

EPA Placebo

EPA- placebo softgel (Containing 2 g edible paraffin oil), 4 × 500 mg softgel daily, 2 times a day, for 8 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Eicosapentaenoic acid

Eligibility Criteria

Inclusion Criteria

• Willingness to collaborate in the study
• aged 35-50 years
• having a history of at least 1 year of type 2 diabetes mellitus before the participation in the study based on FBS ≥126 mg/dl or 2hPG ≥200 mg/dl (2-hour plasma glucose),
• 25≤BMI<30 kg/m2

Exclusion Criteria

• pregnant and breastfeeding women
• using insulin, alcohol consumption, smoking and other drugs
• taking drugs (lipid-lowering, β-blockers, diuretics, estrogens, progesterones, vitamin supplements and ω-3 fatty acid supplements
• followers of the special diet
• history of diabetic retinopathy or diabetic nephropathy
• type 1 diabetes mellitus and other disorders
• any need to take insulin, change in the dose (s) and type of medication or physical activity

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tehran University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohammad Hassan Golzari, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS)

Mahmoud Djallali, Ph.D

Role: STUDY_CHAIR

Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS)

Saeed Hosseini, MD,Ph.D

Role: STUDY_DIRECTOR

Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS)

Locations

Tehran University of Medical Sciences (TUMS), School of Nutritional Sciences and Dietetics, Department of Cellular and Molecular Nutrition

Tehran, , Iran

Countries

Iran

References

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.

Reference Type: DERIVED

PMID: 30746344 (View on PubMed)

Other Identifiers

15202

Identifier Type: -

Identifier Source: org_study_id