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

NCT ID: NCT02382471

Last Updated: 2015-03-06

Basic Information

• 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

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.

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 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.

Conditions

Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

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

Interventions

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

n-3 fatty acids; n-3 PUFA

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Tehran University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohammad Hasan Javanbakht, MD, Ph.D

Role: STUDY_DIRECTOR

Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS)

Locations

Tehran University of Medical Sciences

Tehran, , Iran

Countries

Iran

Other Identifiers

159753

Identifier Type: -

Identifier Source: org_study_id