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

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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CVD, Omega-3

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

Group Type ACTIVE_COMPARATOR

Omega-3

Intervention Type DIETARY_SUPPLEMENT

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

CVD, Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Omega-3

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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n-3 fatty acids n-3 PUFA

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No