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

NCT02261545 | Unknown Phase 4 DMC

• 1 other identifier: 25367
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Diabetes Mellitus Type II

Keywords

n-3 fatty acid; Sirt-1; AdipoR1; AdipoR2; MCP-1; Adiponectin; Resistin; T2DM

Outcome Measures

Primary Outcomes (1)

• Serum Fasting Blood Sugar(FBS)

  Change from baseline at 10 weeks

Secondary Outcomes (13)

• Serum Insulin

  Change from baseline at 10 weeks

• Serum HbA1C

  Change from baseline at 10 weeks

• Serum Resistin

  Change from baseline at 10 weeks

• Serum adiponectin

  Change from baseline at 10 weeks

• Serum mcp-1

  Change from baseline at 10 weeks

Study Arms (2)

n-3 Fatty Acid Supplemetation

ACTIVE COMPARATOR

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

Dietary Supplement: n-3 Fatty Acid

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

n-3 Fatty Acid 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.

Also known as: omega-3, n-3 PUFA

n-3 Fatty Acid Supplemetation

Placebo 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.

Placebo

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Related Publications (1)

• 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.

  PMID: 29900143 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Fatty Acids, Omega-3; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 10, 2014
• Study Start: September 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2016
• Last Updated: November 18, 2015

Record last verified: 2015-11