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Maki K.C.,Biofortis Clinical Research | Maki K.C.,Midwest Center for Metabolic and Cardiovascular Research | Lawless A.L.,Biofortis Clinical Research | Kelley K.M.,Biofortis Clinical Research | And 4 more authors.
Journal of Clinical Lipidology | Year: 2015

BACKGROUND: Restricted intakes of saturated and trans-fatty acids is emphasized in heart-healthy diets, and replacement with poly- and monounsaturated fatty acids is encouraged. OBJECTIVE: To compare the effects of polyunsaturated fatty acid-rich corn oil (CO) and monounsaturated fatty acid-rich extra-virgin olive oil (EVOO) on plasma lipids in men and women (N = 54) with fasting low-density lipoprotein cholesterol (LDL-C) ≥130 mg/dL and <200 mg/dL and triglycerides (TG) ≤350 mg/dL. METHODS: In a double-blind, randomized, crossover design (21-day treatments, 21-day washout between), 4 tablespoons/day CO or EVOO were provided in 3 servings study product/day (muffin, roll, yogurt) as part of a weight-maintenance diet (∼35% fat, <10% saturated fat, <300 mg cholesterol). Subjects ate breakfast at the clinic every weekday throughout the study. Lunches, dinners, and snacks (and breakfasts on weekends) were provided for consumption away from the clinic. RESULTS: Baseline mean (standard error) lipids in mg/dL were: LDL-C 153.3 (3.5), total cholesterol (total-C) 225.7 (3.9), non-high-density lipoprotein (non-HDL)-C 178.3 (3.7), HDL-C 47.4 (1.7), total-C/HDL-C 5.0 (0.2), and TG 124.8 (7.2). CO resulted in significantly larger least-squares mean % changes (all P < .001 vs EVOO) from baseline in LDL-C -10.9 vs -3.5, total-C -8.2 vs -1.8, non-HDL-C -9.3 vs -1.6, and total-C/HDL-C -4.4 vs 0.5. TG rose a smaller amount with CO, 3.5 vs 13.0% with EVOO (P = .007). HDL-C responses were not significantly different between conditions (-3.4 vs -1.7%). CONCLUSION: Consumption of CO in a weight-maintenance, low saturated fat and cholesterol diet resulted in more favorable changes in LDL-C and other atherogenic lipids vs EVOO. © 2015 National Lipid Association.

Maki K.C.,Biofortis Clinical Research | Maki K.C.,Midwest Center for Metabolic and Cardiovascular Research | Nieman K.M.,Biofortis Clinical Research | Schild A.L.,Biofortis Clinical Research | And 4 more authors.
Journal of Nutrition | Year: 2015

Background: Dietary patterns characterized by high intakes of fruits and vegetables, whole grains, low-fat dairy products, and low glycemic load have been associated with lower type 2 diabetes mellitus (T2DM) risk. In contrast, dietary patterns that include high intakes of refined grains, processed meats, and high amounts of added sugars have been associated with increased T2DM risk. Objective: This randomized, 2-period crossover trial compared the effects of dairy and sugar-sweetened product (SSP) consumption on insulin sensitivity and pancreatic b-cell function in men and women at risk of the development of T2DM who habitually consume sugar-sweetened beverages. Methods: In a randomized, controlled crossover trial, participants consumed dairy products (474 mL/d 2% milk and 170 g/d low-fat yogurt) and SSPs (710 mL/d nondiet soda and 108 g/d nondairy pudding), each for 6 wk, with a 2-wk washout between treatments. A liquid meal tolerance test (LMTT) was administered at baseline and the end of each period. Results: Participants were 50% female with a mean age and body mass index of 53.8 y and 32.2 kg/m2, respectively. Changes from baseline were significantly different between dairy product and SSP conditions for median homeostasis model assessment 2-insulin sensitivity (HOMA2-%S) (1.3 vs. 221.3%, respectively, P = 0.009; baseline = 118%), mean LMTT disposition index (20.03 vs.20.36, respectively, P = 0.011; baseline = 2.59), mean HDL cholesterol (0.8 vs.24.2%, respectively, P = 0.015; baseline = 44.3 mg/dL), and mean serum 25-hydroxyvitamin D [25(OH)D] (11.7 vs. 23.3, respectively, P = 0.022; baseline = 24.5 μg/L). Changes from baseline in LMTT Matsuda insulin sensitivity index (20.10 vs. 20.49, respectively; baseline = 4.16) and mean HOMA2-β-cell function (22.0 vs. 5.3%, respectively; baseline = 72.6%) did not differ significantly between treatments. Conclusion: These results suggest that SSP consumption is associated with less favorable values for HOMA2-%S, LMTT disposition index, HDL cholesterol, and serum 25(OH)D in men and women at risk of T2DM vs. baseline values and values during dairy product consumption. This trial was registered at clinicaltrials.gov as NCT01936935. © 2015 American Society for Nutrition.

Liska D.J.,Biofortis Innovation Services | Kern H.J.,Biofortis Innovation Services | Maki K.C.,Midwest Center for Metabolic and Cardiovascular Research
Advances in Nutrition | Year: 2016

Cranberry has been used traditionally to prevent urinary tract infections (UTIs), primarily among generally healthy women prone to recurrent UTIs. Results from a number of published clinical studies have supported this benefit; however, meta-analyses on cranberry and UTI prevention have reported conflicting conclusions. This article explores the methodological differences that contributed to these disparate findings. Despite similar research questions, the meta-analyses varied in the studies that were included, as well as the data that were extracted. In the 2 most comprehensive systematic reviews, heterogeneity was handled differently, leading to an I2 of 65% in one and 43% in the other. Most notably, the populations influencing the conclusions varied. In one analysis, populations with pathological/physiological conditions contributed 75.6% of the total weight to the summary risk estimate (RR: 0.86; 95% CI: 0.71, 1.04); another weighted the evidence relatively equally across UTI populations (RR: 0.62; 95% CI: 0.49, 0.80); and a third included only women with recurrent UTIs (RR: 0.53; 95% CI: 0.33, 0.83). Because women with recurrent UTIs are the group to whom most recommendations regarding cranberry consumption is directed, inclusion of other groups in the efficacy assessment could influence clinical practice quality. Therefore, conclusions on cranberry and UTIs should consider differences in results across various populations studied when interpreting results from meta-analyses. © 2016 American Society for Nutrition.

Rice H.B.,Global Organization for EPA and DHA Omega 3s GOED | Bernasconi A.,Global Organization for EPA and DHA Omega 3s GOED | Maki K.C.,Midwest Center for Metabolic and Cardiovascular Research | Harris W.S.,Health Diagnostic Laboratory | And 4 more authors.
Prostaglandins Leukotrienes and Essential Fatty Acids | Year: 2016

In contrast to earlier long-chain (LC) omega-3 (i.e. EPA and DHA) investigations, some recent studies have not demonstrated significant effects of EPA and DHA on cardiovascular disease (CVD) outcomes. The neutral findings may have been due to experimental design issues, such as: maintenance on aggressive cardiovascular drug treatment overshadowing the benefits of LC omega-3s, high background LC omega-3 intake, too few subjects in the study, treatment duration too short, insufficient LC omega-3 dosage, increase in omega-6 fatty acid intake during the study, failure to assess the LC omega-3 status of the subjects prior to and during treatment and lack of clarity concerning which mechanisms were expected to produce benefits. At the 11th ISSFAL Congress, a workshop was held on conducting LC omega-3 clinical trials with cardiovascular outcomes, with the goal of gaining a better understanding concerning aspects of experimental design that should be considered when planning clinical studies related to EPA and DHA and potential cardiovascular benefits. © 2016 The Authors.

Rains T.M.,SALTT LLC | Rains T.M.,Biofortis Clinical Research | Leidy H.J.,University of Missouri | Sanoshy K.D.,Biofortis Clinical Research | And 3 more authors.
Nutrition Journal | Year: 2015

Background: Dietary protein at breakfast has been shown to enhance satiety and reduce subsequent energy intake more so than carbohydrate or fat. However, relatively few studies have assessed substitution of protein for carbohydrate on indicators of appetite and glucose homeostasis simultaneously. Methods: The acute appetitive and metabolic effects of commercially-prepared sausage and egg-based breakfast meals at two different protein levels (30 g and 39 g/serving), vs. a low-protein pancake breakfast (3 g protein) and no breakfast (water), were examined in premenopausal women (N = 35; age 32.5 ± 1.6 yr; BMI 24.8 ± 0.5 kg/m2). Test products provided ~280 kcal/serving and similar fat (12-14 g) and fiber contents (0-1 g). Visual Analog Scale ratings for appetite (hunger, fullness, prospective consumption, desire to eat) and repeated blood sampling for plasma glucose and insulin concentrations were assessed throughout each test day. Energy intake was recorded at an ad libitum lunch meal at 240 min. Results: Results showed increased satiety ratings for both the 30 and 39 g protein meals vs. the low-protein and no breakfast conditions (p < 0.001 for all). Postprandial glucose and insulin excursions were lower following the 30 g and 39 g protein conditions vs. the low-protein condition, with smaller responses following the 39 g vs. 30 g protein condition (p < 0.05 for all). Energy intake at lunch was significantly less (p < 0.001) following the 39 g protein meal (692 kcal) vs. the low-protein and no breakfast conditions (789 and 810 kcal, respectively). Total energy intake from the test condition + lunch was higher (p < 0.01) for the 30 and 39 g meals (982 and 983 kcal, respectively) vs. no breakfast (810 kcal), and less than the low protein breakfast (1064 kcal; p < 0.01 vs. 39 g condition only). Conclusions: Results suggest that convenience meals providing 30 or 39 g protein/serving produce greater appetite control, lower postprandial glycemia and insulinemia, and reduced subsequent intake at lunch relative to a low-protein control, or no breakfast. Trial registration: NCT01713114 © 2015 Rains et al.; licensee Biomed Central.

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