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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Omega-3

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 4

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Tehran University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: CVD, Placebo; patients with cardiovascular disease who receive 4 cap of placebo/day	Dietary supplement: Placebo; 4 cap 1 g Placebo(paraffin) per day for 2 months
Active Comparator: CVD, Omega-3; patients with Cardiovascular disease who receive 4g/d omega-3	Dietary supplement: Omega-3; 4 cap 1 g Omega-3 per day for 2 months; Other Names: n-3 fatty acids; n-3 PUFA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum Irisin	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
Serum Myostatin	Change from baseline at 2 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Serum high-sensitivity C-reactive protein (hsCRP)	Change from baseline at 2 months

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences
• Investigators: Study Director: Mohammad Hasan Javanbakht, MD, Ph.D, Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS)

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: February 16, 2015
• First Submitted That Met QC Criteria: March 2, 2015
• First Posted (Estimate): March 6, 2015

Study Record Updates

• Last Update Posted (Estimate): March 6, 2015
• Last Update Submitted That Met QC Criteria: March 2, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: atherosclerotic; BDNF; Follistatin; Irisin
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 159753

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No