Clinical trial NCT02382471: Assessing the Effects of Omega-3 Supplementation on Some Serum BDNF، Follistatin، Irisin Levels in Men With CAD
Official title: Assessing the Effects of Omega-3 Supplementation on Some Serum BDNF، Follistatin، Irisin Levels in Men With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Disease
Keywords: atherosclerotic
BDNF
Follistatin
Irisin
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-03-06
Enrollment: 21
Sex: MALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Serum Irisin
timeFrame: Change from baseline at 2 months
measure: Serum Brain-Derived Neurotrophic Factor(BDNF)
timeFrame: Change from baseline at 2 months
measure: Serum Follistatin
timeFrame: Change frome baseline at 2 months
measure: Serum Myostatin
timeFrame: Change from baseline at 2 months
Secondary outcomes:
measure: Serum high-sensitivity C-reactive protein (hsCRP)
timeFrame: Change from baseline at 2 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran University of Medical Sciences
Study officials:
affiliation: Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS)
name: Mohammad Hasan Javanbakht, MD, Ph.D
role: STUDY_DIRECTOR
References: