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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT02382471
First received: February 16, 2015
Last updated: March 2, 2015
Last verified: March 2015
  Purpose
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 Intervention Phase
Cardiovascular Disease Dietary Supplement: Omega-3 Dietary Supplement: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • 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 ]

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

Enrollment: 21
Study Start Date: December 2011
Study Completion Date: October 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   45 Years to 65 Years   (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02382471

Locations
Iran, Islamic Republic of
Tehran University of Medical Sciences
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Study Director: Mohammad Hasan Javanbakht, MD, Ph.D Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS)
  More Information

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02382471     History of Changes
Other Study ID Numbers: 159753
Study First Received: February 16, 2015
Last Updated: March 2, 2015

Keywords provided by Tehran University of Medical Sciences:
atherosclerotic
BDNF
Follistatin
Irisin

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 26, 2017