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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02382471
Recruitment Status : Completed
First Posted : March 6, 2015
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Dietary Supplement: Omega-3 Dietary Supplement: Placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessing the Effects of Omega-3 Supplementation on Some Serum BDNF، Follistatin، Irisin Levels in Men With Coronary Artery Disease
Study Start Date : December 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Serum Irisin [ Time Frame: Change from baseline at 2 months ]
  2. Serum Brain-Derived Neurotrophic Factor(BDNF) [ Time Frame: Change from baseline at 2 months ]
  3. Serum Follistatin [ Time Frame: Change frome baseline at 2 months ]
  4. Serum Myostatin [ Time Frame: Change from baseline at 2 months ]

Secondary Outcome Measures :
  1. Serum high-sensitivity C-reactive protein (hsCRP) [ Time Frame: Change from baseline at 2 months ]

Eligibility Criteria
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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02382471


Locations
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Iran, Islamic Republic of
Tehran University of Medical Sciences
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
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Study Director: Mohammad Hasan Javanbakht, MD, Ph.D Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS)
More Information
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Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02382471    
Other Study ID Numbers: 159753
First Posted: March 6, 2015    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015
Keywords provided by Tehran University of Medical Sciences:
atherosclerotic
BDNF
Follistatin
Irisin
Additional relevant MeSH terms:
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Cardiovascular Diseases