Dietetics and Clinical Nutrition Commons^™

Quality By Design: Process Trajectory Development For A Dynamic Pharmaceutical Coprecipitation Process Based On An Integrated Real‐Time Process Monitoring Strategy, Huiquan Wu, Mansoor A. Khan

United States Food and Drug Administration: Publications

Increasing prevalence of poorly water‐soluble drugs in pharmaceutical development provides notable risks of new products demonstrating low and erratic bioavailability. This dissolution‐limited bioavailability may have consequences for safety and efficacy, particularly for drugs delivered by the oral route of administration. Several novel drug delivery technologies have been developed to improve drug solubility, dissolution rates, and bioavailability. Among those are solid dispersion, nanotechnology, supercritical fluid technology, lipid‐based technology, and crystal engineering. Although these strategies are available for enhancing the bioavailability of drugs with low aqueous solubility, the success of these approaches is not yet guaranteed and is greatly dependent on the …

The Impact Of The Boxed Warning On The Duration Of Use For Depot Medroxprogesterone Acetate, Efe Eworuke, Joo-Yeon Lee, Lisa Soule, Vaishali Popat, David G. Moeny

United States Food and Drug Administration: Publications

Objective The objective of this study was to examine the impact of the Food and Drug Administration’s boxed warning on the utilization of depot medroxyprogesterone (DMPA).

Methods From the IMS Lifelink data (2001–2009), we identified DMPA and oral combined hormonal contraceptive (CHC) users without a prescription claim 6 months before and after the first and last claim. Episodes were defined as all contiguous claims with no more than 90- day DMPA or 30-day CHC between claims. Days’ supply (CHC) and 90-day duration (DMPA) was used to determine episodes. We used interrupted time series to evaluate changes in the mean episode …

Modeling And Statistical Issues Related To Salmonella In Low Water Activity Foods, Sofia M. Santillana Farakos, Michelle Danyluk, Donald Schaffner, Régis Pouillot, Linda J. Harris, Bradley P. Marks

United States Food and Drug Administration: Publications

The presence and survival of Salmonella in low water activity (a_w) foods continues to pose a challenge for the food industry. Peer‐reviewed literature data on prevalence and levels of contamination of Salmonella in low water activity foods in the United States are limited. Available published data include those on: Salmonella contamination on nuts and peanuts (Calhoun et al., 2013), almonds (Danyluk et al., 2007; Bansal et al., 2010), pecans (Brar, Strawn, and Danyluk, 2016), and walnuts (Davidson et al., 2015); prevalence and levels of Salmonella on spices (Van Doren et al., 2013); as …

Disparities In Hypertension And Cardiovascular Disease In Blacks: The Critical Role Of Medication Adherence, Keith C. Ferdinand, Kapil Yadav, Samar A. Nasser, Helene D. Clayton-Jeter, John Lewin, Dennis R. Cryer, Fortunato Fred Senatore

United States Food and Drug Administration: Publications

Blacks are two to three times as likely as whites to die of preventable heart disease and stroke. Declines in mortality from heart disease have not eliminated racial disparities. Control and effective treatment of hypertension, a leading cause of cardiovascular disease, among blacks is less than in whites and remains a challenge. One of the driving forces behind this racial/ethnic disparity is medication nonadherence whose cause is embedded in social determinants. Eight practical approaches to addressing medication adherence with the potential to attenuate disparities were identified and include: (1) patient engagement strategies, (2) consumer-directed health care, (3) patient portals, (4) …

Current Practices In Corrosion, Surface Characterization, And Nickel Leach Testing Of Cardiovascular Metallic Implants, Srinidhi Nagaraja, Matthew Di Prima, David Saylor, Erica Takai

United States Food and Drug Administration: Publications

In an effort to better understand current test practices and improve nonclinical testing of cardiovascular metallic implants, the Food and Drug Administration (FDA) held a public workshop on Cardiovascular Metallic Implants: corrosion, surface characterization, and nickel leaching. The following topics were discussed: (1) methods used for corrosion assessments, surface characterization techniques, and nickel leach testing of metallic cardiovascular implant devices, (2) the limitations of each of these in vitro tests in predicting in vivo performance, (3) the need, utility, and circumstances when each test should be considered, and (4) the potential testing paradigms, including acceptance criteria for each test. In …

High Throughput Quantification Of Apolipoproteins A-I And B-100 By Isotope Dilution Ms Targeting Fast Trypsin Releasable Peptides Without Reduction And Alkylation, Bryan A. Parks, David M. Schieltz, Michael L. Andrews, Michael S. Gardner, John C. Rees, Christopher A. Toth, Jeffrey I. Jones, Lisa G. Mcwilliams, Zsuzsanna Kuklenyik, James L. Pirkle, John R. Barr

United States Food and Drug Administration: Publications

Purpose: Apolipoprotein A-I (ApoA-I) and apolipoprotein B-100 (ApoB-100) are amphipathic proteins that are strong predictors of cardiovascular disease risk. The traceable calibration of apolipoprotein assays is a persistent challenge, especially for ApoB-100, which cannot be solubilized in purified form.

Experimental design: A simultaneous quantitation method for ApoA-I and ApoB-100 was developed using tryptic digestion without predigestion reduction and alkylation, followed by LC separation coupled with isotope dilution MS analysis. The accuracy of the method was assured by selecting structurally exposed signature peptides, optimal choice of detergent, protein: enzyme ratio, and incubation time. Peptide calibrators were value assigned by isobaric tagging …

Microbial Ecology Of Fresh Vegetables, J. Zheng, A. De Jesus, S. Sahu, A. E. Hayford, Y. Luo, A. R. Datta, E. W. Brown, R. Bell

United States Food and Drug Administration: Publications

The total consumption of fresh and processed vegetables has exceeded 123 kg per capita in the United States and 118 kg per capita in the European Union (http://www.helgilibrary.com/ indicators/index/vegetable‐consumption‐percapita) in 2009. Changes in lifestyles and consumption trends have prompted the sustained growth of fresh‐cut or minimally processed vegetables that are fresh and ready‐to‐eat (RTE). In 2011, for example, total US fresh‐cut produce sales through both food service and retail channels were estimated to surpass $27 billion (Cook et al., 2012).

Adolescent Food Purchasing Patterns And The Association With Dietary Intake And Body Mass Index In Rural Communities In Kentucky And North Carolina, Paige M. Connelly

Theses and Dissertations--Nutrition and Food Systems

The local food environment plays an important role in the health of adolescents, especially in rural areas. Often, rural areas lack the accessibility and availability of healthy food choices, making a healthy lifestyle difficult to achieve. This study presents a cross-sectional survey of rural adolescents in 8 counties in Kentucky and North Carolina to determine the association between food store choice, body mass index (BMI), and key dietary outcomes. Although BMI had no association with food store choice, those who infrequently shopped at gas stations, convenience stores, and fast food restaurants consumed significantly less added sugar (p < 0.05) than those who shopped at those stores more regularly. Increasing the availability and accessibility of food venues with healthy food options such as supermarkets may decrease added sugar intake among rural adolescents.

Hemp: A Composition Review Plus, Agustin Gonzalo Miguel Garcia

Food Science and Nutrition

Hemp has been utilized by many societies around the world yet is currently absent in U.S. food production. The paper described and assessed various sources to aggregate hemp seed composition data and to decipher hemp seed consumption effect on health. There are copious components in hemp seeds that are discussed; some beneficial to human health as well as some anti-nutritional components that interfere. Numerous articles were analyzed and aspects of each were compiled to provide a source to assess the effectiveness of hemp seed as a nutritious source. Many components found in hemp seeds are found to be beneficial to …

Blurred Lines: Emerging Practice For Registered Dietitian-Nutritionists In Integrative And Functional Nutrition, Patricia Grace-Farfaglia, Denise L. Pickett-Bernard, Andrea Gorman, Jaleh Dehpahlavan

Nutrition Sciences Faculty Publications

Background This study explored the health philosophy and practice orientation of RDNs in the United States. Methods A randomly selected group of RDNs were recruited to take an online survey using a reduced version of Integrative Medicine practice (IM-30). Confirmatory factor analysis, analyses of variance, and non-parametric tests were used to investigate the relationships between dietetic professionals' personal health philosophy, lifestyle, and orientation to Integrative Medicine. Results Overall construct validity of the IM-26 scale was demonstrated by Cronbach's α with reliabilities ranging from 0.766 to 0.89. Results from chi-square test of goodness-of-fit test (N = 477, χ2 = 228.72, p …

Impact Of Omega-3 Fatty Acid Supplementation On Baseline Levels Of Inflammatory Markers In The General Population, Alex Nhan

Honors Undergraduate Theses

Inflammation is a complex physiological response normally initiated by the innate immune system, often as a response to exposure to otherwise harmful stimuli. While generally useful in humans as a protective response to foreign matter, chronically elevated quantities of associated inflammatory factors C-reactive protein, TNF-alpha, IL-6, and IL-1beta have been linked in literature with decreased overall lifespan and well-being in humans via inflammatory processes. It is possible that by lowering these associated factors, increased well-being and lifespan may be experienced by the general population. One common health supplement with such promise is fish oil, which, through compounds eicosapentaenoic acid and …

The School Food Environment And Its Association With Dietary Intake Among Rural Adolescents, Hannah F. Hickey

Theses and Dissertations--Nutrition and Food Systems

The school food environment has the ability to increase the consumption of fruit and vegetables in rural adolescents. This study used a survey to allow adolescents in seven rural counties to self-report their fruit and vegetable intake as well as utilizing the USDA Mathematica tool and the School Nutrition and Meal Cost Study audits to evaluate what food and beverage products were actually available to adolescents. By using these two measures, associations between fruit and vegetable intake and availability of healthy and unhealthy foods were determined. The availability of healthy snacks and beverages was found to be associated with sugar-sweetened …

Steroids: A Growing Dilemma In Athletics, Seara Ontiveros

Nebraska College Preparatory Academy: Senior Capstone Projects

A comprehensive and straight forward description of what exactly steroids are and what they do to the body is described by Gary Wadler, a health major at the New York University School of Medicine, he comments: “When the receptor sites in their bodies, which don’t have much testosterone in them, suddenly are presented with a lot of testosterone, they get activated…The unbalance of hormones increases the red blood cell formations... They’ll get more muscular, more defined. They’ll lose some fat, and increase their lean body mass, [they’ll] get stronger”. Although anabolic steroids and other hormones are consumed by many athletes …

Association Between Plant-Based Diets And Plasma Lipids: A Systematic Review And Meta-Analysis, Yoko Yokohama, Susan Levin, Neal Barnard

Medicine Faculty Publications

Context: Although a recent meta-analysis of randomized controlled trials showed that adoption of a vegetarian diet reduces plasma lipids, the association between vegetarian diets and long-term effects on plasma lipids has not been subjected to meta-analysis.

Objective: The aim was to conduct a systematic review and meta-analysis of observational studies and clinical trials that have examined associations between plant-based diets and plasma lipids.

Data Sources: MEDLINE, Web of Science, and the Cochrane Central Register of Controlled Trials were searched for articles published in English until June 2015.

Study Selection: The literature was searched for controlled trials and observational studies …

Exploring Community-Based Nutrition Education Programs On Children’S Knowledge Of Effective Budgeting And Nutritional Analysis, Danielle Beard, Katie Harris, Charlotte Harrison, Amanda Hawley, Kerri Healy, Ashley Tuttle

OUR Journal: ODU Undergraduate Research Journal

Children from low-income areas, ages 5-18, are at high risk for obesity and other related nutritional issues, partially due to lack of knowledge about effective budgeting and nutritional content analysis. Little information is known about the education provided by current community programs in Hampton Roads for teaching children to 1) shop smart, 2) read nutrition labels, and 3) the importance of eating healthier. We propose a longitudinal (12-week) observational study to determine what community-based education is provided to children on how and why to shop smart and read nutritional content; and to determine whether or not the education is effective. …

Nutritional Status Of Food Insecure Older Adults, Chelsie Walker, Lindsey Asbury, Javier Way, Brent Johnson, Alex Biddle, Courtney Wagner

OUR Journal: ODU Undergraduate Research Journal

Approximately 9.8 million seniors across America were at risk of going hungry in 2015. The percentage of seniors who faced the threat of hunger was equivalent to the percentage of seniors compared with the whole population of the United States. The prevalence rate of hypertension, which contributes to heart attacks and strokes, is over 50%, and the prevalence rate of diabetes is over 25% in seniors. Both heart disease and diabetes are among the top 10 leading causes of death in America with heart disease being number one. Appropriate dieting is recommended as a way to prevent and treat both …

Let Them Eat Beef: Effects Of Beef Consumption On Markers Of Metabolic Syndrome, Kristin L. Olson

Electronic Theses and Dissertations

To determine the effects of a diet that provides 30% energy from protein with ½ as lean, red meat on risk factors of metabolic syndrome in humans. This pilot study was a 3- month, randomized, control, intervention trial with 33 participants (Beef-Intervention n=18; DASH-Control n=15) who displayed markers of metabolic syndrome. Registered Dietitians Nutritionists recruited and educated participants on Beef-Intervention Lean Beef Pattern, (30% of energy from protein with ½ as lean red meat, 40% carbohydrate, 30% fat) or DASH-Control dietary pattern, (15% of energy from protein, 55% carbohydrate and 30 % fat). Of the 33 participants who completed the …

Nutritional Needs In Collegiate Female Soccer Athletes, Alysa M. Brown

Graduate Student Theses, Dissertations, & Professional Papers

Brown, Alysa, ATC, Spring 2017 Athletic Training

Nutritional Needs in Collegiate Female Soccer Athletes

Chairperson: Dr. Valerie Moody

Many times, athletes do not have enough time to meet their nutritional needs. They are busy going to school, attending meetings, lifting weights, receiving treatments and attending practices and may forget to eat or simply do not have enough time. Several studies suggest nutritional knowledge and habits directly impact how well an athlete will perform. Due to the rigorous training regimen of a collegiate athlete, they should be fueling their bodies throughout the day to maximize their performance. The Women’s soccer team …

The Financial Burdens Associated With Managing Pku Dietary Needs As An Adult, Melissa C. Bernzen

Masters Theses

This study was designed to identify the financial burdens associated with purchasing medical foods and the impact this has on the dietary management of adults with PKU. PKU is a genetic disorder in which the body cannot metabolize the amino acid, phenylalanine, which occurs in all foods with protein. Dietary treatment of foods low in protein along with medical supplementation is required for the treatment of PKU. If PKU is left untreated this can lead to severe neurological damage. Medical guidelines indicate that dietary treatment is needed for the duration of one's life, but the medical foods needed are expensive …

Recent Analytical Methods For The Analysis Of Sweeteners In Food: A Regulatory Perspective, Romina Shah, Lowri S. De Jager

United States Food and Drug Administration: Publications

Non-nutritive or low calorie sweeteners are commonly used worldwide in the food industry, often in combination in order to limit undesirable tastes. The list of allowable sweeteners varies among countries and it is important for regulatory agencies and food safety laboratories to monitor these highly consumed products to ensure compliance with worldwide regulations. Current analytical methods for confirmation and quantification of sweeteners must allow for confirmation of analyte identity in order to be compatible with today’s standards. Various methods for the determination of non-nutritive sweeteners have been reported in the literature. Th e most common multi-sweetener methods involve high performance …