Clinical trial NCT02052986: An Open-Label Study of Vascazen in Cardiac Rehab Patients With Deficient Blood Omega-3 Fatty Acid Levels
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Dyslipidemia
Keywords: Fatty Acids, Omega-3
Omega-3 fatty acids
Docosahexaenoic acid (DHA)
Eicosapentaenoic acid (EPA)
Docosapentaenoic acid (DPA)
Omega Index
Omega Score
Cardiac Rehab
Lead sponsor: New York Hospital Queens
Sponsor class: OTHER
Collaborators: name: NYHQ Cardiac Health Center
name: Pivotal Therapeutics
First posted: 2014-02-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The investigators aim to test the hypothesis that dietary supplementation with VASCAZEN will correct omega-3 deficiency in cardiac rehab patients and improve biochemical risk factors.


Eligibility criteria: Inclusion Criteria:

* Adult subjects (\> or = 18 years of age)
* Enrolled in Cardiac Rehabilitation clinic with documented cardiovascular disease as assessed by the principle investigator
* Has had cardiovascular examination within the past 2 months

Exclusion Criteria:

* Subjects who refuse to provide written consent
* Subjects with medical conditions, as determined by the principal investigator, which prevented them from study participation
* Subjects with a known bleeding or clotting disorder
* Subjects with known allergies to fish
* Subjects with an implantable cardiac defibrillator
* Subjects with a heart transplant
* Female subjects who are currently taking hormone replacement therapy
* Subjects who are pregnant or planning on becoming pregnant
* Subjects currently taking Omega-3 fatty acid supplements (either under medical supervision or self-administered)

Primary outcomes:
measure: Change in sum of Omega-Score and Omega-Index
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in patient health questionnaire-9 (PHQ-9) depression scale
timeFrame: 12 weeks
Other outcomes:
measure: Change in Omega-3 Score and Omega-3 Index
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in high-sensitivity C-reactive protein (hsCRP)
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in blood levels of total cholesterol, low-density lipoprotein (LDL), high density lipoprotein (HDL), very-low density lipoprotein (VLDL) cholesterol and their subfractions (particle size)
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in blood level of Triglycerides
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in fasting plasma glucose
timeFrame: Baseline,12 weeks
measure: Change in blood glucose and insulin measurements following administration of oral glucose tolerance test (OGTT)
timeFrame: Baseline, 12 weeks
measure: Change in glycated hemoglobin (HbA1c)
timeFrame: Baseline,12 weeks
measure: Change in Lipoprotein associated Phospholipase (Lp-PLA2)
timeFrame: Baseline, 6 weeks, 12 weeks
Locations:
city: Fresh Meadows
country: United States
facility: The NYHQ Cardiac Health Center
state: New York
Study officials:
affiliation: New York Hospital Queens
name: Brian S Marino, DO
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Mori TA, Burke V, Puddey IB, Watts GF, O'Neal DN, Best JD, Beilin LJ. Purified eicosapentaenoic and docosahexaenoic acids have differential effects on serum lipids and lipoproteins, LDL particle size, glucose, and insulin in mildly hyperlipidemic men. Am J Clin Nutr. 2000 May;71(5):1085-94. doi: 10.1093/ajcn/71.5.1085.
citation: Grimsgaard S, Bonaa KH, Hansen JB, Nordoy A. Highly purified eicosapentaenoic acid and docosahexaenoic acid in humans have similar triacylglycerol-lowering effects but divergent effects on serum fatty acids. Am J Clin Nutr. 1997 Sep;66(3):649-59. doi: 10.1093/ajcn/66.3.649.
citation: Geleijnse JM, Giltay EJ, Grobbee DE, Donders AR, Kok FJ. Blood pressure response to fish oil supplementation: metaregression analysis of randomized trials. J Hypertens. 2002 Aug;20(8):1493-9. doi: 10.1097/00004872-200208000-00010.
citation: Thies F, Garry JM, Yaqoob P, Rerkasem K, Williams J, Shearman CP, Gallagher PJ, Calder PC, Grimble RF. Association of n-3 polyunsaturated fatty acids with stability of atherosclerotic plaques: a randomised controlled trial. Lancet. 2003 Feb 8;361(9356):477-85. doi: 10.1016/S0140-6736(03)12468-3.
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citation: Harris WS, Von Schacky C. The Omega-3 Index: a new risk factor for death from coronary heart disease? Prev Med. 2004 Jul;39(1):212-20. doi: 10.1016/j.ypmed.2004.02.030.
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citation: Derosa G (2011) Effects of n-3 PUFA on Insulin Resistance After an Oral Fat Load. European Journal of Lipid Science. 113: (8) 950-960