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

NCT ID: NCT02261545

Last Updated: 2015-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-02-29

Brief Summary

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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

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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

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Diabetes Mellitus Type II

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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n-3 Fatty Acid Supplemetation

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

Group Type ACTIVE_COMPARATOR

n-3 Fatty Acid

Intervention Type DIETARY_SUPPLEMENT

n-3 Fatty Acid supplement, 3 × 1000 mg softgel daily (2700 mg EPA+DHA per day), 3 times a day, for 10 weeks.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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omega-3 n-3 PUFA

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Mazaherioun M, Saedisomeolia A, Javanbakht MH, Koohdani F, Zarei M, Ansari S, Khoshkhoo Bazargani F, Djalali M. Long Chain n-3 Fatty Acids Improve Depression Syndrome in Type 2 Diabetes Mellitus. Iran J Public Health. 2018 Apr;47(4):575-583.

Reference Type DERIVED
PMID: 29900143 (View on PubMed)

Other Identifiers

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25367

Identifier Type: -

Identifier Source: org_study_id