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

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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

Tracking Information
First Submitted Date  ICMJE February 16, 2015
First Posted Date  ICMJE March 6, 2015
Last Update Posted Date March 6, 2015
Study Start Date  ICMJE December 2011
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2015)
  • Serum Irisin [ Time Frame: Change from baseline at 2 months ]
  • Serum Brain-Derived Neurotrophic Factor(BDNF) [ Time Frame: Change from baseline at 2 months ]
  • Serum Follistatin [ Time Frame: Change frome baseline at 2 months ]
  • Serum Myostatin [ Time Frame: Change from baseline at 2 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2015)
Serum high-sensitivity C-reactive protein (hsCRP) [ Time Frame: Change from baseline at 2 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessing the Effects of Omega-3 Supplementation on Some Serum BDNF، Follistatin، Irisin Levels in Men With CAD
Official Title  ICMJE Assessing the Effects of Omega-3 Supplementation on Some Serum BDNF، Follistatin، Irisin Levels in Men With Coronary Artery Disease
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cardiovascular Disease
Intervention  ICMJE
  • Dietary Supplement: Omega-3
    4 cap 1 g Omega-3 per day for 2 months
    Other Names:
    • n-3 fatty acids
    • n-3 PUFA
  • Dietary Supplement: Placebo
    4 cap 1 g Placebo(paraffin) per day for 2 months
Study Arms  ICMJE
  • Placebo Comparator: CVD, Placebo
    patients with cardiovascular disease who receive 4 cap of placebo/day
    Intervention: Dietary Supplement: Placebo
  • Active Comparator: CVD, Omega-3
    patients with Cardiovascular disease who receive 4g/d omega-3
    Intervention: Dietary Supplement: Omega-3
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2015)
21
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 45 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02382471
Other Study ID Numbers  ICMJE 159753
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tehran University of Medical Sciences
Study Sponsor  ICMJE Tehran University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mohammad Hasan Javanbakht, MD, Ph.D Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS)
PRS Account Tehran University of Medical Sciences
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP