Provident Clinical Research

Addison, IL, United States

Provident Clinical Research

Addison, IL, United States

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Heaney R.P.,Creighton University | Kopecky S.,Mayo Medical School | Maki K.C.,Provident Clinical Research | Hathcock J.,John Hathcock Consulting | And 2 more authors.
Advances in Nutrition | Year: 2012

A group of academic and industry experts in the fields of nutrition, cardiology, epidemiology, food science, bone health, and integrative medicine examined the data on the relationship between calcium supplement use and risk of cardiovascular events, with an emphasis on 4 of the Bradford Hill criteria for causal inference: strength, consistency, dose-response, and biological plausibility. Results from 2 epidemiological studies and a meta-analysis of randomized, controlled clinical trials, including a subgroup analysis from the Women's Health Initiative, have prompted concern about a potential association between calcium supplement use and a small increase in the risk of adverse cardiovascular events. However, a number of issues with the studies, such as inadequate compliance with the intervention, use of nontrial calcium supplements, potential bias in event ascertainment, and lack of information on and adjustment for known cardiovascular risk determinants, suggest that bias and confounding cannot be excluded as explanations for the reported associations. Findings from other cohort studies also suggest no detrimental effect of calcium from diet or supplements, with or without vitamin D, on cardiovascular disease risk. In addition, little evidence exists for plausible biological mechanisms to link calcium supplement use with adverse cardiovascular outcomes. The authors do not believe that the evidence presented to date regarding the hypothesized relationship between calcium supplement use and increased cardiovascular disease risk is sufficient to warrant a change in the Institute of Medicine recommendations, which advocate use of supplements to promote optimal bone health in individuals who do not obtain recommended intakes of calcium through dietary sources. © 2012 American Society for Nutrition.


Bays H.E.,Atherosclerosis Research Center | Evans J.L.,Stratum Nutrition | Evans J.L.,0 Research Park Drive | Maki K.C.,Provident Clinical Research | And 4 more authors.
European Journal of Clinical Nutrition | Year: 2013

Background/objectives: Elevated oxidized low-density lipoprotein (OxLDL) may promote inflammation, and is associated with increased risk of atherosclerotic coronary heart disease and worsening complications of diabetes mellitus. The primary objective of this study was to evaluate the efficacy of chitin-glucan (CG), alone and in combination with a potentially anti-inflammatory olive oil (OO) extract, for reducing OxLDL in subjects with borderline to high LDL cholesterol (LDL-C) levels. Subjects/methods: This 6-week, randomized, double-blind, placebo-controlled study of a novel, insoluble fiber derived from the Aspergillus niger mycelium, CG, evaluated 130 subjects free of diabetes mellitus with fasting LDL-C 3.37-4.92 mmol/l and glucose ≤6.94 mmol/l. Participants were randomly assigned to receive CG (4.5 g/day; n=33), CG (1.5 g/day; n=32), CG (1.5 g/day) plus OO extract (135 mg/day; n=30), or matching placebo (n=35). Results: Administration of 4.5 g/day CG for 6 weeks significantly reduced OxLDL compared with placebo (P=0.035). At the end of study, CG was associated with lower LDL-C levels relative to placebo, although this difference was statistically significant only for the CG 1.5 g/day group (P=0.019). CG did not significantly affect high-density lipoprotein cholesterol, triglycerides, glucose, insulin or F2-isoprostane levels. Adverse events did not substantively differ between treatments and placebo. Conclusions: In this 6-week study, CG (4.5 g/day) reduced OxLDL, an effect that might affect the risk for atherosclerosis. © 2013 Macmillan Publishers Limited.


Maki K.C.,Provident Clinical Research | Rubin M.R.,Provident Clinical Research | Wong L.G.,Shaklee Corp. | McManus J.F.,Shaklee Corp. | And 2 more authors.
International Journal of Food Sciences and Nutrition | Year: 2011

The objective of the present trial was to assess the effects of vitamin D supplementation on serum 25-hydroxyvitamin D [25(OH)D] and high-density lipoprotein cholesterol (HDL-C) in subjects with high waist circumference. Subjects were randomly assigned a daily multivitamin and mineral (MVM) supplement or a MVM supplement plus vitamin D 1,200 IU/day (MVM+D) for 8 weeks. There was a significant difference in mean change for 25(OH)D between the MVM and MVM+D treatment groups (-1.2 ± 2.5 nmol/l vs. 11.7 ± 3.0 nmol/l, respectively; P = 0.003). Vitamin D 1,200 IU/day did not increase 25(OH)D to a desirable level ( ≥ 75 nmol/l) in 61% of participants. There were no significant changes in cardiovascular disease risk markers. Thus, vitamin D supplementation with 1,200 IU/day was insufficient to achieve desirable serum 25(OH)D in most participants and did not affect cardiovascular disease risk markers. © 2011 Informa UK, Ltd.


Maki K.C.,Provident Clinical Research | Bays H.E.,Louisville Metabolic and Atherosclerosis Research Center | Dicklin M.R.,Provident Clinical Research | Johnson S.L.,Glaxosmithkline | Shabbout M.,Glaxosmithkline
Journal of Clinical Lipidology | Year: 2011

Background: Prescription omega-3-acid ethyl esters (POM3) reduce triglycerides (TG) and very low-density lipoprotein cholesterol and increase high-density lipoprotein cholesterol (HDL-C) in patients with hypertriglyceridemia. Objective: To examine the effects of POM3 plus atorvastatin versus placebo plus atorvastatin on lipoprotein particle concentrations and sizes, apolipoprotein (Apo) CIII, and lipoprotein-associated phospholipase A2 mass in subjects with mixed dyslipidemia. Methods: After a 4-week diet lead in, men and women with non-HDL-C >160 mg/dL and TG 250-599 mg/dL, while taking no lipid-altering drugs, received double-blind 4 g/d POM3 (n = 118) or placebo (n = 119) with open-label atorvastatin 10 mg/d for 8 weeks, followed by escalation to 20 mg/d atorvastatin for 4 weeks, then 40 mg/d atorvastatin for 4 weeks. Results: Total low-density lipoprotein particle (LDL-P) concentration decreased significantly from baseline, and the reductions did not differ between the POM3 and placebo groups (-659.7 vs -624.4 nmol/L, P =.181). With POM3, compared with placebo, small LDL-P concentration decreased (P =.026), large LDL-P concentration increased (P <.001), mean LDL-P size increased (P =.001), a larger fraction of subjects switched from LDL subclass pattern B to A, and Apo CIII and lipoprotein-associated phospholipase A 2 levels were reduced (P <.001). The incremental effects of POM3 were similar across atorvastatin doses for most variables. Conclusion: This analysis supports the view that LDL-P concentration is not increased by POM3 plus atorvastatin, relative to atorvastatin monotherapy, and is associated with potentially favorable shifts in LDL-P subfractions, Apo CIII and lipoprotein-associated phospholipase A2 in mixed dyslipidemia. © 2011 National Lipid Association. All rights reserved.


Bays H.E.,Louisville Metabolic and Atherosclerosis Research Center | Maki K.C.,Provident Clinical Research | Schmitz K.,Louisville Metabolic and Atherosclerosis Research Center
International Journal of Clinical Practice | Year: 2010

Aims: The primary objective of this study was to validate a novel Bile Acid Sequestrant Acceptability (BASA) Scale intended to assess the acceptability andor tolerability of bile acid sequestrant (BAS) beverage preparations. A secondary objective was to assess the utility of weightings based on subjective clinical importance for the BASA scale individual components and its composite score. Methods: This was a randomised, single-blind, single site, controlled study of oral administration of 4 g of orange-flavoured generic cholestyramine powder, 12 g of orange-flavoured generic cholestyramine powder and an orange-flavoured sweetened control drink powder, each mixed with water. Results: The study sample included 42 subjects; 26 men and 16 women. Participants were non-Hispanic white (76.2%) or blackAfrican American (23.8%), with a mean age of 51.4 years and body mass index of 30.1 kgm 2. The components of the BASA scale were taste, texture, appearance and mixability; the possible total BASA scores ranged being 4-20; the higher the BASA scale score, the better the acceptabilitytolerability. Composite BASA scale scores were significantly lower for the 4 g (mean BASA score = 10.3) and 12 g (mean BASA score = 9.4) cholestyramine compared with the control drink powder (mean BASA score = 16.7) (p < 0.001). BASA scale scores did not significantly differ between the 4 and 12 g of cholestyramine. (p = 0.215). Weighting of the components did not materially alter the results. Findings for the individual components of the BASA scale were similar to the composite values. Conclusion: The BASA scale effectively distinguished between an orange-flavoured BAS powder and a commercial orange-flavour control powder. © 2010 Blackwell Publishing Ltd.


Bays H.E.,Louisville Metabolic and Atherosclerosis Research Center | Maki K.C.,Provident Clinical Research | Schmitz K.,Louisville Metabolic and Atherosclerosis Research Center
Endocrine Practice | Year: 2011

Objective: To compare tolerability of colesevelam hydrochloride powder versus a cholesterol-lowering equivalent dose of generic cholestyramine powder, each mixed in water, by means of the validated Bile Acid Sequestrant Acceptability (BASA) Scale.Methods: We conducted a randomized, single-blind, single-visit, single-site study, comparing doses of 2 different bile acid sequestrant powders for oral suspension that produce similar cholesterol lowering: colesevelam hydrochloride (3.75 g) and generic cholestyramine (12 g), each mixed in a transparent cup with tap water.Results: The study sample consisted of 42 participants-12 men and 30 women. The study subjects were non-Hispanic white (64%) or black (36%), with a mean age of 50 years and a mean body mass index of 32.2 kg/m2. The components of the BASA Scale included taste, texture, appearance, and mixability. Colesevelam hydrochloride and cholestyramine did not differ significantly when assessed by both the unweighted and the weighted global BASA Scale. Although study participants indicated that the colorless or whitish colesevelam hydrochloride powder tasted better (P<.0001), they thought that the orange-colored cholestyramine had a more appealing appearance (P<.0001). Regarding the potential for taking the drug "for the rest of your life," 71.4% of study participants rated taste as "very important," and 11.9% rated appearance as "very important."Conclusion: Although study participants thought that the orange-colored generic cholestyramine powder had a better appearance, they also reported that colesevelam hydrochloride for oral suspension tasted better. A minority of study participants thought appearance was "very important"; a substantial majority thought taste was "very important" for potential long-term compliance. Copyright © 2011 AACE.


Maki K.C.,Provident Clinical Research | Rains T.M.,Provident Clinical Research | Dicklin M.R.,Provident Clinical Research | Bell M.,ClinData Services Inc.
Diabetes Technology and Therapeutics | Year: 2010

Background: The objective of this investigation was to evaluate the test-retest repeatability of insulin sensitivity and secretion indices derived from liquid meal tolerance tests (MTTs) in subjects with normal fasting glucose (NFG) (n=20), impaired fasting glucose (IFG) (n=20), or type 2 diabetes mellitus (n=38). Methods: The Matsuda Index of insulin sensitivity and a Disposition Index (the product of the Matsuda Index and the ratio of the total areas under the curves for glucose and insulin from 0 to 120min) were assessed in two standard liquid MTTs, separated by approximately 1 week. Results: Mean±SD Matsuda Index values were 14.2±7.6, 8.8±4.7, and 6.3±4.0, and Disposition Index values were 1,009.6±355.5, 671.4±249.0, and 201.8±101.3 for NFG, IFG, and diabetes, respectively (all P<0.05 except Matsuda Index for IFG vs. diabetes, P=0.241). Differences between tests in subjects with NFG, IFG, and diabetes, respectively, were-0.2±3.6 (coefficient of variation for the method error, 17.9%), 0.2±3.2 (26.1%), and 0.1±3.0 (34.1%) for the Matsuda Index and 16.5±225.8 (16.1%), 13.3±221.6 (23.1%), and 15.2±79.4 (28.1%) for the Disposition Index. Conclusions: The Matsuda and Disposition indices derived from liquid MTTs appropriately ranked categories of fasting glucose tolerance and have repeatability profiles suggesting potential usefulness in population studies and moderately sized clinical trials requiring repeated measurements. © Copyright 2010, Mary Ann Liebert, Inc.


Maki K.C.,Provident Clinical Research | Rains T.M.,Provident Clinical Research
Journal of Nutrition | Year: 2012

The consumption of EPA and DHA has been associated with reduced risk for cardiovascular disease morbidity andmortality. Mean intakes of EPA and DHA in the United States and elsewhere are below levels recommended by health authorities. The main non-marine source of dietary (n-3) fatty acids (a-linolenic acid) is poorly converted to EPA in humans. Stearidonic acid (SDA) is a non-marine fatty acid that appears to be more readily converted to EPA in humans. Results from previous studies suggested that SDA, relative to EPA, increases RBC EPA, with reported efficiencies ranging from;16 to 30%. A recently published, randomized, single-blind, controlled, parallel group study in healthy men and women characterized the relationships between intakes of SDA and EPA and EPA enrichment of RBC membranes over a 12-wk period.%EPA in RBC membraneswas greater after EPA (0.44, 1.3, or 2.7 g/d, respectively) and SDA (1.3, 2.6, or 5.2 g/d, respectively) consumption compared to a safflower control (all P, 0.02). Based on quadratic response surface models, for EPA intakes of 0.25, 0.50, and 0.89 g/d, SDA intakes of 0.61, 1.89, and 5.32 g/d, respectively, would be required to produce equivalent values for RBC% EPA, translating to relative efficiencies of 41.0, 26.5, and 16.7%. Thus, dietary SDA over a range of intakes increases RBC% EPA, with declining relative efficiency as SDA intake increases. © 2012 American Society for Nutrition.


Davidson M.H.,University of Chicago | Kling D.,Omthera Pharmaceuticals | Maki K.C.,Provident Clinical Research
Current Opinion in Lipidology | Year: 2011

Purpose of review: Omega-3 polyunsaturated fatty acids (n-3 PUFAs) have been attributed with several health benefits, including triglyceride lowering and cardiovascular disease risk reduction. This review focuses on new prescription omega-3 fatty acid products in development and recently published data regarding omega-3 fatty acid effects on arrhythmias, heart failure, and platelet inactivation. Recent findings: A free fatty acid form of n-3 PUFA was found to produce a four-fold higher area under the plasma n-3 PUFA curve than prescription omega-3-acid ethyl esters in patients on a low-fat diet. Eicosapentaenoic acid ethyl esters reduced triglyceride without significantly elevating LDL cholesterol in patients with severe hypertriglyceridemia and in those with mixed dyslipidemia. Recent investigations of n-3 PUFA effects on ventricular and atrial arrhythmias, including studies in patients with implanted defibrillators, failed to demonstrate a significant benefit. However, increased fatty fish or n-3 PUFA consumption was associated with a lower rate of hospitalization in heart failure patients. A further important finding was potentiation of the antiplatelet response when n-3 PUFAs were added to aspirin+?clopidogrel. Summary: Although n-3 PUFA therapy continues to show promise in the prevention and management of cardiovascular diseases, further research is necessary to more fully elucidate its role in specific disorders. © 2011 Wolters Kluwer Health | Lippincott Williams & Wilk.


Maki K.C.,Provident Clinical Research | Lawless A.L.,Provident Clinical Research | Kelley K.M.,Provident Clinical Research | Dicklin M.R.,Provident Clinical Research | And 4 more authors.
Journal of Cardiovascular Pharmacology | Year: 2011

This double-blind, randomized crossover study investigated the effects of 6 weeks of treatment with prescription omega-3-acid ethyl esters (POM3, 4 g/day) versus placebo (soy oil) on low-density lipoprotein cholesterol (LDL-C) and other aspects of the fasting lipid profile in 31 men and women with primary, isolated hypercholesterolemia (LDL-C 130-220 mg/dL and triglycerides less than 150 mg/dL while free of lipid-altering therapies). Mean ± standard error of the mean baseline concentrations of total cholesterol, LDL-C, high-density lipoprotein cholesterol (HDL-C), very-low-density lipoprotein cholesterol, and triglycerides were 229 ± 3, 146 ± 3, 60 ± 2, 23 ± 2, and 113 ± 8 mg/dL, respectively. POM3 produced a modest increase from baseline in LDL-C (3.4%) versus the placebo response (-0.7%, P = 0.010). Significant changes (P < 0.05) for POM3 (placebo-corrected) were observed for very-low-density lipoprotein cholesterol (-18.8%), triglycerides (-18.7%), and HDL-C (3.3%). Nuclear magnetic resonance-determined very-low-density lipoprotein particle concentration and size and HDL particle concentration decreased significantly more with POM3 versus placebo, whereas LDL and HDL particle sizes increased significantly more with POM3 versus placebo. Total cholesterol, non-HDL-C, apolipoproteins A1 and B, and LDL particle concentration responses did not differ between treatments. These results did not confirm the hypothesis that POM3 treatment would lower LDL-C in primary, isolated hypercholesterolemia. Effects on other variables were consistent with prior results in mixed dyslipidemia. Copyright © 2011 by Lippincott Williams & Wilkins.

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