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Maki K.C.,Midwest Center for Metabolic and Cardiovascular Research | Geohas J.G.,Evanston Premier Healthcare Research | Dicklin M.R.,Midwest Center for Metabolic and Cardiovascular Research | Huebner M.,ClinData Services Inc. | Udani J.K.,Medicus Research LLC
Prostaglandins Leukotrienes and Essential Fatty Acids | Year: 2015

This randomized, double-blind, placebo-controlled multi-center trial investigated the lipid-altering effects of a medical food (PDL-0101) providing 1.8. g/d eicosapentaenoic acid; 12. mg/d astaxanthin, a marine algae-derived carotenoid; and 100. mg/d tocopherol-free gamma/delta tocotrienols enriched with geranylgeraniol, extracted from annatto, on triacylglycerols (TAG), other lipoprotein lipids, and oxidized low-density lipoprotein (LDL) in 102 subjects with TAG 150-499. mg/dL (1.69-5.63. mmol/L) and LDL cholesterol (LDL-C) ≥70. mg/dL (1.81. mmol/L). Compared to placebo, after eight weeks of treatment, PDL-0101 significantly reduced median TAG (-9.5% vs. 10.6%, p<0.001), while not significantly altering mean LDL-C (-3.0% vs. -8.0% for PDL-0101 and placebo, respectively, p=0.071), mean high-density lipoprotein cholesterol (~3% decrease in both groups, p=0.732), or median oxidized LDL concentrations (5% vs. -5% for PDL-0101 and placebo, respectively, p=0.112). These results demonstrate that PDL-0101 is an effective medical food for the management of elevated TAG. © 2015 Elsevier Ltd.

Udani J.K.,Medicus Research LLC | Udani J.K.,Northridge | Bloom D.W.,Medicus Research LLC
Nutrition Journal | Year: 2013

Objective. To evaluate the efficacy of Kivia powder on supporting overall gut health through the relief of the discomfort of occasional constipation. Design. Randomized, double-blind, placebo-controlled, parallel-group trial. Interventions. The investigational product for this study was Kivia powder (Vital Food Processors Ltd., Auckland, New Zealand), containing the active ingredient Zyactinase™, 5.5 g taken daily for four weeks. Results: One hundred thirty-eight subjects reporting occasional constipation were screened and 87 were randomized to placebo (n = 44) and product (n = 43). Bowel movement frequency, as measured by both average daily spontaneous bowel movements (SBM) and complete spontaneous bowel movements (CSBM), were the same in both groups at baseline. There were significant increases in spontaneous bowel movements at week 1 (p = 0.001), week 2 (p = 0.001), week 3 (p = 0.000), and week 4 (p = 0.000) compared to baseline. SBM demonstrated significant differences between the treatment group and the placebo group at week 3 (p = 0.000), and week 4 (p = 0.020). The treatment group demonstrated a significantly higher rate of SBM at week 3 (p = 000) and from baseline to week 4 (p = 0.019). Significant increases in complete spontaneous bowel movements were observed at week 1 (p = 0.000), week 2 (p = 0.000), week 3 (p = 0.000), and week 4 (p = 0.000) compared to baseline. Moreover, CSBM was significantly higher for the treatment group compared to placebo at week 2 (p = 0.001). The change in average daily CSBM from baseline to week 2 was significantly higher in the treatment group than in the placebo group (p = 0.004).Abdominal discomfort or pain demonstrated significant differences between groups at week 1 (p = 0.044) and week 3 (p = 0.026). Flatulence was significantly lower for active group compared to placebo at week 2 (p = 0.047) and week 3 (p = 0.023). The number of bowel movements associated with urgency was significantly lower in the treatment group compared to the placebo group at week 3 (p = 0.048). In addition, it was decreased from baseline to week 1 (p = 0.040) and from baseline to week 3 (p = 0.024) in the treatment group, while the placebo group did not report any reductions in bowel urgency. Bowel movements in the treatment arm were significantly smoother and softer by week 2 (p = 0.020) and week 3 (p = 0.041). Conclusions: Treatment with Kivia powder, an extract of kiwifruit containing Zyactinase™, for four weeks was well tolerated and more effective than placebo in gently enhancing bowel movement frequency and reducing abdominal pain and flatulence in subjects with occasional constipation. Trial registration. ISRCTN: ISRCTN49036618. © 2013 Udani and Bloom; licensee BioMed Central Ltd.

Lugo J.P.,InterHealth Nutraceuticals | Saiyed Z.M.,InterHealth Nutraceuticals | Lau F.C.,InterHealth Nutraceuticals | Molina J.P.L.,Medicus Research LLC | And 4 more authors.
Journal of the International Society of Sports Nutrition | Year: 2013

Background: UC-II contains a patented form of undenatured type II collagen derived from chicken sternum. Previous preclinical and clinical studies support the safety and efficacy of UC-II in modulating joint discomfort in osteoarthritis and rheumatoid arthritis. The purpose of this study was to assess the efficacy and tolerability of UC-II in moderating joint function and joint pain due to strenuous exercise in healthy subjects.Methods: This randomized, double-blind, placebo-controlled study was conducted in healthy subjects who had no prior history of arthritic disease or joint pain at rest but experienced joint discomfort with physical activity. Fifty-five subjects who reported knee pain after participating in a standardized stepmill performance test were randomized to receive placebo (n = 28) or the UC-II (40 mg daily, n = 27) product for 120 days. Joint function was assessed by changes in degree of knee flexion and knee extension as well as measuring the time to experiencing and recovering from joint pain following strenuous stepmill exertion.Results: After 120 days of supplementation, subjects in the UC-II group exhibited a statistically significant improvement in average knee extension compared to placebo (81.0 ± 1.3o vs 74.0 ± 2.2o; p = 0.011) and to baseline (81.0 ± 1.3o vs 73.2 ± 1.9o; p = 0.002). The UC-II cohort also demonstrated a statistically significant change in average knee extension at day 90 (78.8 ± 1.9o vs 73.2 ± 1.9o; p = 0.045) versus baseline. No significant change in knee extension was observed in the placebo group at any time. It was also noted that the UC-II group exercised longer before experiencing any initial joint discomfort at day 120 (2.8 ± 0.5 min, p = 0.019), compared to baseline (1.4 ± 0.2 min). By contrast, no significant changes were seen in the placebo group. No product related adverse events were observed during the study. At study conclusion, five individuals in the UC-II cohort reported no pain during or after the stepmill protocol (p = 0.031, within visit) as compared to one subject in the placebo group.Conclusions: Daily supplementation with 40 mg of UC-II was well tolerated and led to improved knee joint extension in healthy subjects. UC-II also demonstrated the potential to lengthen the period of pain free strenuous exertion and alleviate the joint pain that occasionally arises from such activities. © 2013 Lugo et al.; licensee BioMed Central Ltd.

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