Dyslipidemia
Conditions
Keywords
Fatty Acids, Omega-3, Omega-3 fatty acids, Docosahexaenoic acid (DHA), Eicosapentaenoic acid (EPA), Docosapentaenoic acid (DPA), Omega Index, Omega Score, Cardiac Rehab
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.
Interventions
OTHERVASCAZEN
All enrolled subjects will receive 4 capsules daily of VASCAZEN which delivers 3.0 grams of EPA and DHA
Sponsors
NYHQ Cardiac Health Center
Pivotal Therapeutics
New York Hospital Queens
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in sum of Omega-Score and Omega-Index | 12 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in patient health questionnaire-9 (PHQ-9) depression scale | 12 weeks | Change in patient health questionnaire-9 (PHQ-9) depression scale after 12 weeks of study treatment |
Other
| Measure | Time frame |
|---|---|
| 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 |
| Change in blood glucose and insulin measurements following administration of oral glucose tolerance test (OGTT) | Baseline, 12 weeks |
| Change in fasting plasma glucose | Baseline,12 weeks |
| Change in Lipoprotein associated Phospholipase (Lp-PLA2) | Baseline, 6 weeks, 12 weeks |
| Change in blood level of Triglycerides | Baseline, 6 weeks, 12 weeks |
| Change in glycated hemoglobin (HbA1c) | Baseline,12 weeks |
Countries
United States
Contacts
Primary ContactBrian S Marino, DO
Backup ContactDonna Cheslik, RN, MSN
Outcome results
None listed