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

Tehran University of Medical Sciences

Status and phase: Unknown; Phase 4

Conditions: Diabetes Mellitus Type II

Treatments: Dietary Supplement: Placebo; Dietary Supplement: n-3 Fatty Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02261545

25367

Details and patient eligibility

About

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

Full 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

Enrollment: 88 estimated patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• willingness to participation,
• diabetic patients 30- 60 years old,
• body mass index in the range 25-40,
• avoidance of dietary supplements,
• vitamins and herbal products at least 3 months before and throughout the intervention

Exclusion criteria

• people who have used n-3 Fatty Acid Supplementation in last 3 months,
• having chronic renal disease ,
• GI disease,
• Hepatobiliary diseases,
• hematological disorders,
• hypo- or hyperthyroidism,
• type 1 diabetes,
• treatment with orlistat or sibutramine for weight loss,
• pregnancy and lactation,
• treatment with insulin or Thiazolidinediones.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups, including a placebo group

n-3 Fatty Acid Supplemetation

Active Comparator group

Description:

patients with Type II Diabetes who receive 3 cap omega3, 3 times a day, for 10 weeks.

Treatment:

Dietary Supplement: n-3 Fatty Acid

Placebo

Placebo Comparator group

Description:

patients with Type II Diabetes who receive 3 cap of placebo/ for 10 weeks.

Treatment:

Dietary Supplement: Placebo