Assessing the Effects of Omega-3 Supplementation on Serum HSP27, HSP70, YKL40, BMP-4 Levels in Male Patient With CAD

Phase 4

Completed

• Conditions: Cardiovascular Disease
• Interventions: Dietary Supplement: Omega-3; Dietary Supplement: Placebo

• Registration Number: NCT02117960
• Lead Sponsor: Tehran University of Medical Sciences

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 BMP-4, YKL40, HSP70, HSP27 in patients with cardiovascular disease.

Detailed Description

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 BMP-4, YKL40, HSP70, HSP27 in patients with cardiovascular disease. In this randomized, double-blind clinical trial, placebo-controlled, single-center, and phase two trials, 42men aged 45-65 years with Coronary Artery Disease are enrolled in the study from Tehran Heart Center. After signing informed consent all individuals complete a general information form , 24-hour food recall for 3 days 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 4 g/day omega 3 fatty acid for 8 weeks and the placebo group will also receive placebo (containing 4 g 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 8-12 hours fasting and anthropometric variables, biochemical parameters and physical activity before and after the trial will be measured.

Study Timeline

• Study Start: 2011-12
• Primary Completion: 2013-08
• Study Completion: 2013-10
• Study First Submitted: 2014-04-16
• Study First Submitted QC: 2014-04-16
• Study First Posted: 2014-04-21
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 21

Inclusion Criteria

• 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,

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CVD, Omega-3	Omega-3	patients with Cardiovascular disease who receive 4g/d omega-3
CVD, Placebo	Placebo	patients with cardiovascular disease who receive 4 cap of placebo/day

Primary Outcome Measures

Name	Time	Method
Serum Heat Shock Protein 70(HSP70)	Change frome baseline at 2 months

Secondary Outcome Measures

Name	Time	Method
Serum BMP4 (Bone Morphogenic Protein4)	Change frome baseline at 2 months
Serum Heat Shock Protein 27(HSP27)	Change frome baseline at 2 months
Serum Ox-LDL	Change frome baseline at 2 months
Serum YKL40	Change frome baseline at 2 months
Serum hsCRP	Change frome baseline at 2 months

Trial Locations

Locations (1)

Tehran University of Medical Sciences; 🇮🇷 Tehran, Iran, Islamic Republic of