NCT02261545

The Effect of n-3 Fatty Acid Supplementation on Serum Levels, and Gene Expression of type2 Diabetes Patient

The Effect of n-3 Fatty Acid Supplementation on the Expression of Sirt-1, Adiponectin Receptor 1 (AdipoR1) & Adiponectin Receptor 2 (AdipoR2) Genes of PBMC and Circulatory Levels of Resistin,Monocyte Chemotactic Protein (MCP-1) and Adiponectin of type2 Diabetes Patient

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Tehran University of Medical Sciences · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to determine the effects of supplementation with n-3 fatty acid or placebo for 10 weeks on the expression of Sirt-1, AdipoR1 \& AdipoR2 genes in the peripheral blood mononuclear cell (PBMC) and circulatory levels of Resistin, MCP-1 and Adiponectin of type2 diabetes patient

Detailed description

The aim of this study is to determine of the effects of supplementation with n-3 fatty acid or placebo for 10 weeks on the expression of Sirt-1, AdipoR1(adiponectin receptor 1) \& AdipoR2 (adiponectin receptor 2) genes in the peripheral blood mononuclear cell (PBMC) and circulatory levels of Resistin, MCP-1 (Monocyte Chemoattractant Protein-1) and Adiponectin of type2 diabetes patient. In this randomized, double-blind clinical trial, placebo-controlled, 88 men and women 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 , 24-hour food recall for 3 days and beck depression questionnaire 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. The supplement group, will receive mg 1800mg EPA(Eicosapentaenoic acid ) \& 900mg DHA( docosahexaenoic acid) (total=2700mg) for 10 weeks and the placebo group will also receive placebo (containing 2700 mg 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 12 hours fasting and anthropometric variables, biochemical parameters, target gene expression and physical activity before and after the trial will be measured

Conditions

• Diabetes Mellitus Type II

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	n-3 Fatty Acid	n-3 Fatty Acid supplement, 3 × 1000 mg softgel daily (2700 mg EPA+DHA per day), 3 times a day, for 10 weeks.
DIETARY_SUPPLEMENT	Placebo	3 cap 1 g Placebo(paraffin) per day for 10 weeks. Control Group: n-3 Fatty Acid placebo softgel (Containing 3 g edible paraffin oil), 3 × 1000 mg softgel daily (3 g per day), 3 times a day, for 10 weeks.

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-01-01
• Completion: 2016-02-01
• First posted: 2014-10-10
• Last updated: 2015-11-18