NCT02052986

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 3, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Last Updated

February 3, 2014

Status Verified

January 1, 2014

First QC Date

December 16, 2013

Last Update Submit

January 31, 2014

Conditions

Dyslipidemia

Keywords

Fatty Acids, Omega-3Omega-3 fatty acidsDocosahexaenoic acid (DHA)Eicosapentaenoic acid (EPA)Docosapentaenoic acid (DPA)Omega IndexOmega ScoreCardiac Rehab

Outcome Measures

Primary Outcomes (1)

  • Change in sum of Omega-Score and Omega-Index

    Change in the sum of the subject's blood Eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA) + Docosapentaenoic acid (DPA) levels (Omega-Score) and the change in the sum of the subject's red blood cell (RBC) EPA + DHA levels (Omega-Index) over 12 weeks of study treatment with Vascazen

    12 weeks

Secondary Outcomes (1)

  • Change in patient health questionnaire-9 (PHQ-9) depression scale

    12 weeks

Other Outcomes (8)

  • Change in Omega-3 Score and Omega-3 Index

    Baseline, 6 weeks, 12 weeks

  • Change in high-sensitivity C-reactive protein (hsCRP)

    Baseline, 6 weeks, 12 weeks

  • 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)

    Baseline, 6 weeks, 12 weeks

  • +5 more other outcomes

Study Arms (1)

Vascazen

EXPERIMENTAL

Enrolled patients will receive four capsules daily of VASCAZEN (a 3.0 gram daily dose of EPA+DHA) for a total of 12 weeks.

Other: VASCAZEN

Interventions

VASCAZENOTHER

All enrolled subjects will receive 4 capsules daily of VASCAZEN which delivers 3.0 grams of EPA and DHA

Vascazen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The NYHQ Cardiac Health Center

Fresh Meadows, New York, 11365, United States

Location

Related Publications (11)

  • Albert CM, Campos H, Stampfer MJ, Ridker PM, Manson JE, Willett WC, Ma J. Blood levels of long-chain n-3 fatty acids and the risk of sudden death. N Engl J Med. 2002 Apr 11;346(15):1113-8. doi: 10.1056/NEJMoa012918.

    PMID: 11948270BACKGROUND

  • Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico. Lancet. 1999 Aug 7;354(9177):447-55.

    PMID: 10465168BACKGROUND

  • Bays H. Clinical overview of Omacor: a concentrated formulation of omega-3 polyunsaturated fatty acids. Am J Cardiol. 2006 Aug 21;98(4A):71i-76i. doi: 10.1016/j.amjcard.2005.12.029. Epub 2006 May 30.

    PMID: 16919519BACKGROUND

  • 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.

    PMID: 10799369BACKGROUND

  • 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.

    PMID: 9280188BACKGROUND

  • 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.

    PMID: 12172309BACKGROUND

  • 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.

    PMID: 12583947BACKGROUND

  • Kris-Etherton PM, Harris WS, Appel LJ; American Heart Association. Nutrition Committee. Fish consumption, fish oil, omega-3 fatty acids, and cardiovascular disease. Circulation. 2002 Nov 19;106(21):2747-57. doi: 10.1161/01.cir.0000038493.65177.94. No abstract available.

    PMID: 12438303BACKGROUND

  • 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.

    PMID: 15208005BACKGROUND

  • von Schacky C, Harris WS. Cardiovascular risk and the omega-3 index. J Cardiovasc Med (Hagerstown). 2007 Sep;8 Suppl 1:S46-9. doi: 10.2459/01.JCM.0000289273.87803.87.

    PMID: 17876200BACKGROUND

  • 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

    BACKGROUND

MeSH Terms

Conditions

Dyslipidemias

Interventions

VASCAZEN

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Brian S Marino, DO

    New York Hospital Queens

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian S Marino, DO

CONTACT

814-404-4169brm9071@nyp.org

Donna Cheslik, RN, MSN

CONTACT

718-670-1695djc9001@nyp.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

December 16, 2013

First Posted

February 3, 2014

Primary Completion

January 1, 2015

Last Updated

February 3, 2014

Record last verified: 2014-01

Locations

US(1)