Effect of Omega-3 Supplementation on Serum Level and Gene Expression of IGF-1and IGFBP-3 in Men With CVD.

NCT02092584 | Completed Phase 4 DMC

• 1 other identifier: 5144
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is the comparison between the effects of supplementation with omega 3 or placebo for 8 weeks in serum level of IGF-1 and IGFBP-3 and gene expression of IGF-1 in patients with cardiovascular disease.

Conditions

Cardiovascular Disease

Keywords

atherosclerotic; IGF-1; IGFBP-3

Outcome Measures

Primary Outcomes (9)

• Serum Total Cholesterol

  Change from baseline at 2 months

• Serum HDL-C

  Change frome baseline at 2 months

• Serum LDL-C

  Change frome baseline at 2 months

• Serum TG

  Change frome baseline at 2 months

• Serum Fasting Blood Sugar(FBS)

  Change frome baseline at 2 months

• Serum Insulin

  Change frome baseline at 2 months

• Serum hsCRP

  Change frome baseline at 2 months

• Serum Insulin Like Growth Factor-1(IGF-1)

  Change frome baseline at 2 months

• Serum IGF binding protein 3(IGFBP-3)

  Change frome baseline at 2 months

Secondary Outcomes (2)

• Gene Expression of IGF-1

  Change frome baseline at 2 months

• Gene expression of IGFBP3

  change from baseline at 2 months

Study Arms (2)

CVD, Omega-3

ACTIVE COMPARATOR

patients with Cardiovascular disease who receive 4g/d omega-3

Dietary Supplement: Omega-3

CVD, Placebo

PLACEBO COMPARATOR

patients with cardiovascular disease who receive 4 cap of placebo/day

Dietary Supplement: Placebo

Interventions

Omega-3 DIETARY_SUPPLEMENT

4 cap 1 g Omega-3 per day for 2 months

Also known as: n-3 fatty acids, n-3 PUFA

CVD, Omega-3

Placebo DIETARY_SUPPLEMENT

4 cap 1 g Placebo(paraffin) per day for 2 months

CVD, Placebo

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CVD patients 45- 65 years old, patients with ≥ 50% stenosis in at least one coronary angiogram demonstrated, body mass index in the range 18.5- 35, avoidance of dietary supplements, vitamins and herbal products at least 3 months before and throughout the intervention, willingness to participation,

You may not qualify if:

• people who have used omega 3 supplements in last 3 months, having chronic renal disease , GI disease, hepatobiliary diseases, hematological disorders, hypo- or hyperthyroidism, Smokers

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Tehran University of Medical Sciences

Tehran, Iran

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Docosahexaenoic Acids; Fatty Acids, Omega-3

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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: March 20, 2014
• Study Start: December 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: October 1, 2013
• Last Updated: March 20, 2014

Record last verified: 2014-03

Locations

IR (1)