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

Phase 4

Completed

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

• Registration Number: NCT02382471
• 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 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.

Study Timeline

• Study Start: 2011-12
• Primary Completion: 2013-08
• Study Completion: 2013-10
• Study First Submitted: 2015-02-16
• Status Verified: 2015-03
• Study First Submitted QC: 2015-03-02
• Last Update Submitted: 2015-03-02
• Study First Posted: 2015-03-06
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

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

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Serum Irisin	Change from baseline at 2 months
Serum Myostatin	Change from baseline at 2 months
Serum Brain-Derived Neurotrophic Factor(BDNF)	Change from baseline at 2 months
Serum Follistatin	Change frome baseline at 2 months

Secondary Outcome Measures

Name	Time	Method
Serum high-sensitivity C-reactive protein (hsCRP)	Change from baseline at 2 months

Trial Locations

Locations (1)

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