Cardiovascular Disease
Conditions
Keywords
atherosclerotic, BDNF, Follistatin, Irisin
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.
Interventions
DIETARY_SUPPLEMENTOmega-3
4 cap 1 g Omega-3 per day for 2 months
DIETARY_SUPPLEMENTPlacebo
4 cap 1 g Placebo(paraffin) per day for 2 months
Sponsors
Tehran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
45 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| Serum high-sensitivity C-reactive protein (hsCRP) | Change from baseline at 2 months |
Countries
Iran
Outcome results
None listed