Baseline Physiology Studies in Carriers of Gene Variant X Conferring Major Risk of CVD-prone Metabolic...
HyperlipidemiaDiabetes Mellitus3 moreThe purpose of the present study is to conduct a thorough and relevant physiology study of carriers and non-carriers of the gene variant X in order to determine the effect of the genetic variant on various metabolic parameters.
Efficacy and Safety of Geneferm Nattokinase
HyperlipidemiaNattokinase, first found by Dr. Hiroyuki Sumi in 1980, is a potent fibrinolytic enzyme extracted from Natto, a popular soybean fermented food in Japan. It was confirmed that oral administration of nattokinase (or natto) produced a mild and frequent enhancement of the fibrinolytic activity in the plasma as indicated by the fibrinolytic parameters and the production of tissue plasminogen activator. Other studies also showed a reduction in lipid peroxidation and improvement of lipid metabolism. Short-term effect (less then 10 days) of oral administration of nattokinase on both animal and human subjects has been studied and reported. However, whether nattokinase possesses a beneficial effect to dyslipidemic patients remains unclear. The aim of this study is to investigate the long-term effect (six month) of the mono and multiple formulae of nattokinase, change of BP, lipid and fibrinolytic factors from baseline and 6 months on dyslipidemic patients.
A Study Of Nutraceutical Drinks For Cholesterol (Evaluating Effectiveness and Tolerability)
HyperlipidemiaGreat controversy exists about the feasibility and safety of a product that can be employed for self-directed cholesterol reduction. The position that self-directed cholesterol lowering could lead those that do not need lower cholesterol to take the product is likely unfounded. This is because there is no convincing evidence to suggest that there are cholesterol levels so low that a lower one would not be beneficial or conversely be dangerous. Ample evidence exists that cholesterol causes cardiovascular disease and that lower cholesterol places individuals and populations at lower risk. Because of the high cost, insurance concerns and suboptimal access to physician care, a self-directed, effective and safe approach to cholesterol maintenance or reduction would be very desirable. Drug therapy also has been associated with suboptimal results. Though a new concept that addresses cholesterol by several mechanisms simultaneously has been shown to be more consistently effective and with better tolerability, there is still a need for a self-directed cholesterol optimizing alternative. It is, therefore, our intent in this study to evaluate certain foods, specifically nutraceutical containing fruit flavored drinks in the hopes that they can be proven a safe and effective alternative approach for cholesterol management.
Prioritized Clinical Decision Support (CDS) to Reduce Cardiovascular Risk
HypertensionHyperlipidemia4 moreThe objective of this project is to develop and implement sophisticated point-of-care Electronic Health Record (EHR)-based clinical decision support that (a) identifies and (b) prioritizes all available evidence-based treatment options to reduce a given patient's cardiovascular risk (CVR). After developing the EHR-based decision support intervention, the investigators will test its impact on CVR, the components of CVR, in a group randomized trial that includes 18 primary care clinics, 60 primary care physicians, and 18,000 adults with moderate or high CVR. This approach, if successful, will (a) improve chronic disease outcomes and reduce CVR for about 35% of the U.S. adult population, (b) maximize the clinical return on the massive investments that are increasingly being made in sophisticated outpatient EHR systems, and (c) provide a model for how to use EHR technology support to deliver "personalized medicine" in primary care settings
A Human Trial to Evaluate the Efficacy and Safety of Aged Garlic Powder on Improvement of Blood...
HyperlipidemiaWe performed a double-blind parallel study in a group of mildly hypercholesterolemic subjects who were given aged garlic powder over a period of 12 weeks. We measured serum lipids, including total cholesterol, low-density-lipoprotein (LDL) and high-density-lipoprotein (HDL) cholesterol, and triglycerides, and monitored their blood pressure.
Golden Black Seed: Support of Metabolic Health and General Wellness.
HyperlipidemiasHyperglycemiaTo document effects of consuming Golden Black Seed (brand: New Chapter Inc.) on metabolic health and wellness in human subjects. Golden Black Seed contains extracts from the turmeric root (Curcuma longa) and black cumin seeds (Nigella sativa). Both botanicals have been used traditionally in Asian cooking, and also in herbal medicine for reducing inflammation.
Medication Adherence Clinical Decision Support
HyperlipidemiaHypertension2 moreMore than 50% of adults treated for diabetes, hypertension, or lipid disorders have suboptimal medication adherence, a prominent barrier to continued improvement in chronic disease care in the United States. Primary care providers (PCPs) often fail to identify medication nonadherence and/or have insufficient time and training to address underlying reasons for it. In this project, we propose a patient-centered and technology-driven strategy to identify patients with adherence issues and apply a team approach to help them achieve evidence-based personalized goals for glucose, blood pressure, or lipids. This intervention extends the use of a widely available clinical decision support (CDS) infrastructure to support a model of care that, for the first time outside of a fully integrated care environment, will integrate pharmacists within the primary care team. The intervention relies on a continuous health informatics loop to do the following: (a) identify high-risk patients with adherence problems at the point of care by expanding the capability of an electronic medical record (EMR)-linked CDS to identify poor adherence to medications; (b) establish and maintain an auto-populating up-to-date registry of patients identified for proactive pharmacist outreach; (c) implement a pharmacist outreach strategy based on an information-motivation-behavioral (IMB) framework recommended by the World Health Organization (WHO) with demonstrated ability to influence adherence across a variety of clinical applications; and (d) coordinate care and adherence information by incorporating pharmacist assessment and action plans into CDS at subsequent office encounters.
PROSPective Evaluation of Fortified Eggs Related to Improvement in The Biomarker Profile for Your...
HypercholesterolemiaHyperlipidemia2 moreThe objective of the study is to assess the effect of fortified eggs (compared to a non-egg supplemented diet) and intermittent fasting (IF) (compared to a usual care diet) on biomarker profile at 4 months. This will be a 140-participant, 2x2 factorial, randomized clinical trial comparing fortified eggs vs. a non-egg supplemented diet and IF vs. usual care diet through 4 months. Participants will be randomized 1:1:1:1 to the four treatment groups. Participants will have in-person follow-up visits at 1- and 4- months (inclusive of laboratory assessments) in addition to telephone calls at months 2 and 3. A subset of patients (~24 in each egg randomized strata) will undergo microbiome assessment at baseline and at 4 months.
Postprandial Monocyte Maturation and Vascular Dysfunction Following High-Fat Meals - Study 1
Cardiovascular Risk FactorLipemiaThe purpose of this research study is to examine the effect of high-fat meals on the health of blood vessels. In addition, the study will examine how exercise/fitness/physical activity impacts blood vessels after consumption of a high-fat meal.
Psyllium-enriched Hamburger Meatballs: Effects on Postprandial Lipidemia, Glycemia, Appetite, and...
NutritionHealthy4 moreThe goal of this clinical trial is to enrich the hamburger meatball with psyllium without impairing its sensory properties and to investigate the effects on acute postprandial lipemia and glycemia, prospective food intake, and some appetite indicators in healthy adults. The main hypotheses of the study are: There is no difference in sensory analysis results between hamburger meatballs enriched with psyllium and those that are not enriched. The rise in postprandial lipids after consuming psyllium-enriched hamburger meatballs is lower than that of classic hamburgers. The rise in postprandial glycemia after consuming psyllium-enriched hamburger meatballs is lower than that of classic hamburgers. The feeling of satiety after consuming psyllium-enriched hamburger meatballs lasts longer, and the feeling of hunger lasts for a shorter period compared to classic hamburgers. Daily food intake after consuming psyllium-enriched hamburger meatballs is less than that of classic hamburgers. Participants will, Eat hamburgers, after fasting for 12 hours, with psyllium-enriched and classic meatballs on intervention days. Keep a record of their food intake for the previous and following 24 hours of each intervention. Be given fasting and postprandial blood samples. Evaluate their hunger and satiety levels on a 100 mm horizontal visual analog scale (VAS) at the beginning and every hour for the following 6 hours of the study.