Assessing the Effects of Omega-3 Supplementation on Some Serum BDNF، Follistatin، Irisin Levels in Men With CAD

Cardiovascular Disease Clinical Trial

Official title:

Assessing the Effects of Omega-3 Supplementation on Some Serum BDNF، Follistatin، Irisin Levels in Men With Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02382471
• Other study ID #: 159753
• Status: Completed
• Phase: Phase 4
• First received: February 16, 2015
• Last updated: March 2, 2015
• Start date: December 2011
• Est. completion date: October 2013

Study information

• Verified date: March 2015
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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 BDNF، Follistatin، Irisin in patients with cardiovascular disease.

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 BDNF، Follistatin، Irisin 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 65 Years

Eligibility

Inclusion Criteria:

• cardiovascular disease 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,

• movement disorders,

• myopathy ,

• hypo- or hyperthyroidism,

• Smokers

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Omega-3
4 cap 1 g Omega-3 per day for 2 months
• Placebo
4 cap 1 g Placebo(paraffin) per day for 2 months

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tehran University of Medical Sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Irisin		Change from baseline at 2 months	No
Primary	Serum Brain-Derived Neurotrophic Factor(BDNF)		Change from baseline at 2 months	No
Primary	Serum Follistatin		Change frome baseline at 2 months	No
Primary	Serum Myostatin		Change from baseline at 2 months	No
Secondary	Serum high-sensitivity C-reactive protein (hsCRP)		Change from baseline at 2 months	No