Skip to main content
OpenTrials
Completed

NCT Number: NCT02117960

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

45 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Tehran University of Medical Sciences

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3

Dietary Supplement

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

Other names: n-3 fatty acids, n-3 PUFA

Placebo

Dietary Supplement

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

Primary outcomes

  1. Serum Heat Shock Protein 70(HSP70)

    Time frame: Change frome baseline at 2 months

Secondary outcomes

  1. Serum Ox-LDL

    Time frame: Change frome baseline at 2 months

  2. Serum BMP4 (Bone Morphogenic Protein4)

    Time frame: Change frome baseline at 2 months

  3. Serum Heat Shock Protein 27(HSP27)

    Time frame: Change frome baseline at 2 months

  4. Serum YKL40

    Time frame: Change frome baseline at 2 months

  5. Serum hsCRP

    Time frame: Change frome baseline at 2 months

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 21, 2014
Registry last updated
Apr 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.