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1.  Efficacy of a unique omega-3 formulation on the correction of nutritional deficiency and its effects on cardiovascular disease risk factors in a randomized controlled VASCAZEN® REVEAL Trial 
Low blood levels of long chain omega-3 polyunsaturated fatty acids (LC n-3 PUFA) have been reported to be associated with increased risk for cardiovascular disease (CVD) deaths. Systematic studies measuring LC n-3 PUFA blood levels (pre and post-treatment) in defined subjects, and monitoring the correction of nutritional deficiency with a pure LC n-3 PUFA formulation in sufficient doses, while monitoring CVD risk factors are lacking. We tested the efficacy of a novel LC n-3 PUFA Medical Food formulation (VASCAZEN®, > 90 % pure with a 6:1 eicosapentaenoic acid-(EPA):docosahexaenoic acid-(DHA) ratio; 6:1-OM3), to correct such deficiency and determine the concomitant effects on lipid profiles. Of 655 subjects screened, 89 % were LC n-3 PUFA deficient (Omega-Score, (OS) = blood EPA + DHA + Docosapentaenoic acid < 6.1 %). From these, a study was conducted on 110 ambulatory cardiovascular subjects. Placebo: corn oil. Primary endpoint: change in OS. Secondary endpoint: changes in blood lipid profiles. At 8 weeks of treatment with 6:1-OM3 (4 g/day), placebo-adjusted median OS levels (n = 56) significantly improved (132 %, P < 0.0001) with a decrease in AA (arachidonic acid): EPA ratio (82 %, P < 0.0001). In hypertriglyceridemic subjects (TG 2.26–5.65 mmol/L), HDL-C improved (9 %, P = 0.0069), TG-reduced (48 %, P < 0.0001), and VLDL-C reduced (30 %, P = 0.0023), without significantly affecting LDL-C levels. This study confirms that LC n-3 PUFA deficiency is prevalent in the US population, and its correction with 6:1-OM3 in CVD subjects improves lipid profiles. The purity, EPA:DHA ratio and dose are determinant factors for optimal efficacy of a formulation in reducing CVD risk factors.
PMCID: PMC4176569  PMID: 25185754
Nutrition; Omega-3 (n-3) polyunsaturated fatty acids; Omega-3 deficiency; Lipids and lipoproteins, cardiovascular disease; Biomarkers; Randomized control trials
2.  A randomized clinical trial to determine the efficacy of manufacturers’ recommended doses of omega-3 fatty acids from different sources in facilitating cardiovascular disease risk reduction 
Omega-3 fatty acids confer beneficial health effects, but North Americans are lacking in their dietary omega-3-rich intake. Supplementation is an alternative to consumption of fish; however, not all omega-3 products are created equal. The trial objective was to compare the increases in blood levels of omega-3 fatty acids after consumption of four different omega-3 supplements, and to assess potential changes in cardiovascular disease risk following supplementation.
This was an open-label, randomized, cross-over study involving thirty-five healthy subjects. Supplements and daily doses (as recommended on product labels) were:
Concentrated Triglyceride (rTG) fish oil: EPA of 650 mg, DHA of 450 mg
Ethyl Ester (EE) fish oil: EPA of 756 mg, DHA of 228 mg
Phospholipid (PL) krill oil: EPA of 150 mg, DHA of 90 mg
Triglyceride (TG) salmon oil: EPA of 180 mg, DHA of 220 mg.
Subjects were randomly assigned to consume one of four products, in random order, for a 28-day period, followed by a 4-week washout period. Subsequent testing of the remaining three products, followed by 4-week washout periods, continued until each subject had consumed each of the products. Blood samples before and after supplementation were quantified for fatty acid analysis using gas chromatography, and statistically analysed using ANOVA for repeated measures.
At the prescribed dosage, the statistical ranking of the four products in terms of increase in whole blood omega-3 fatty acid levels was concentrated rTG fish oil > EE fish oil > triglyceride TG salmon oil > PL krill oil. Whole blood EPA percentage increase in subjects consuming concentrated rTG fish oil was more than four times that of krill and salmon oil. Risk reduction in several elements of cardiovascular disease was achieved to a greater extent by the concentrated rTG fish oil than by any other supplement. Krill oil and (unconcentrated) triglyceride oil were relatively unsuccessful in this aspect of the study.
For the general population, the form and dose of omega-3 supplements may be immaterial. However, given these results, the form and dose may be important for those interested in reducing their risk of cardiovascular disease.
Trial registration NCT01960660.
PMCID: PMC4085663  PMID: 24952576
Omega-3 supplements; Cardiovascular disease; Risk biomarkers
4.  Effects of A Breast-Health Herbal Formula Supplement on Estrogen Metabolism in Pre- and Post-Menopausal Women not Taking Hormonal Contraceptives or Supplements: A Randomized Controlled Trial 
Both indole-3-carbinol and dietary lignans have beneficial effects on estrogen metabolism and breast cancer risk. There is no published literature on the effects of a combination product. This study was designed to investigate the impact of a combination product on estrogen metabolism. The major trial objective was to determine whether a breast health supplement containing indole-3-carbinol and hydroxymatairesinol lignan would alter estrogen metabolism to favour C-2 hydroxylation and reduce C-16 hydroxylation. Higher concentrations of C-2 metabolites and lower concentrations of C-16 metabolites may reduce breast cancer risk and risk for other hormonally-related cancers.
Forty-seven pre-menopausal and forty-nine post-menopausal women were recruited for this study, and were divided by random allocation into treatment and placebo group. The treatment supplement contained HMR lignan, indole-3-carbinol, calcium glucarate, milk thistle, Schisandra chinesis and stinging nettle, and each woman consumed either treatment or placebo for 28 days. At day 0 and day 28, blood samples were analysed for serum enterolactone concentrations, and first morning random urine samples were assessed for estrogen metabolites. Repeated measures ANOVA statistical testing was performed.
In pre-menopausal women, treatment supplementation resulted in a significant increase (P < 0.05) in urinary 2-OHE concentrations and in the 2:16α-OHE ratio. In post-menopausal women, treatment supplementation resulted in a significant increase in urinary 2-OHE concentrations. In pre- and post-menopausal women combined, treatment supplementation produced a significant increase in urinary 2-OHE concentration and a trend (P = 0.074) toward an increased 2:16α-OHE ratio. There were no significant increases in serum enterolactone concentrations in the treatment or placebo groups.
Supplementation with a mixture of indole-3-carbinol and HMR lignan in women significantly increased estrogen C-2 hydroxylation. This may constitute a mechanism for the reduction of breast cancer risk as well as risk for other estrogen-related cancers. Further studies with higher numbers of subjects are indicated.
Trial registration registration #NCT01089049.
PMCID: PMC3018890  PMID: 21234288
herbal supplement; breast health; estrogen metabolites

Results 1-4 (4)