NCT03258840

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 23, 2017

Completed
Last Updated

August 23, 2017

Status Verified

December 1, 2011

Enrollment Period

3 months

First QC Date

July 16, 2017

Last Update Submit

August 22, 2017

Conditions

Diabetes Mellitus Type II

Keywords

EPAParaoxonase 1Paraoxonase 2Type 2 diabetes

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    Hemoglobin A1c (HbA1c) measurement by related kits according their protocols

    Change from Baseline at 8 weeks after the intervention

Secondary Outcomes (20)

  • PON2 gene expression

    Baseline, 8 weeks after the intervention

  • Systolic blood pressure

    Change frome baseline at 8 weeks

  • Diastolic blood pressure

    Change frome baseline at 8 weeks

  • serum paraoxonase-1(PON-1) activity

    Baseline, 8 weeks after the intervention

  • PON1/HDL-c Ratio

    Baseline, 8 weeks after the intervention

  • +15 more secondary outcomes

Study Arms (2)

EPA placebo

PLACEBO COMPARATOR

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

Dietary Supplement: EPA Placebo

EPA supplement

ACTIVE COMPARATOR

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

Dietary Supplement: EPA Supplement

Interventions

EPA SupplementDIETARY_SUPPLEMENT

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

Also known as: Eicosapentaenoic acid
EPA supplement
EPA PlaceboDIETARY_SUPPLEMENT

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

EPA placebo

Eligibility Criteria

Age35 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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),
  • ≤BMI\<30 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Tehran, 1471613151, Iran

Location

Related Publications (1)

  • 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.

    PMID: 30746344DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Eicosapentaenoic Acid

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsEicosanoidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2017

First Posted

August 23, 2017

Study Start

January 1, 2013

Primary Completion

April 1, 2013

Study Completion

August 1, 2014

Last Updated

August 23, 2017

Record last verified: 2011-12

Locations

IR(1)