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

Tehran University of Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Cardiovascular Disease

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Omega-3

Study type: Interventional

Funder types: Other

Identifiers

NCT02382471

159753

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: Male

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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21 participants in 2 patient groups, including a placebo group

CVD, Placebo

Placebo Comparator group

Description:

patients with cardiovascular disease who receive 4 cap of placebo/day

Treatment:

Dietary Supplement: Placebo

CVD, Omega-3

Active Comparator group

Description:

patients with Cardiovascular disease who receive 4g/d omega-3

Treatment:

Dietary Supplement: Omega-3