Medicine and Health Sciences Commons^™

Innovation Meets Rigor: A Case Study Of Decentralized Clinical Trials In Consumer Health Research, Belinda Tan

Oxford ICSB

Direct-to-consumer decentralized clinical trials (DCTs) conducted with mobile digital technologies and at-home or local clinical testing are accelerating rigorous clinical studies by virtualizing study activities and collecting data from mobile devices and web-based systems. Through technology automations, decentralized study designs allow for high quality and compliance with objective and subjective data collection. The result is increased study efficiency, high rigor, and more diverse participation, while generating high quality data to meet regulatory standards. Using a proprietary clinical trial software application Chloe, we conducted a double-blinded, randomized, placebo-controlled trial with optional open label extension investigating the impact of 2 doses of …

Cannabidiol And Other Minor Cannabinoids: Pharmacological Targets And Interactions With Thc., Larry Walker

Oxford ICSB

This talk will examine the pharmacology of minor phytocannabinoids, including cannabidiol (CBD) and its interactions with delta-9-tetrahydrocannabinol (THC). Of particular interest is the impact – if any – of varying ratios of THC and CBD on THC responses, and potential mechanisms for the interplay. We will also consider the pharmacology and potential therapeutic impacts of other minor cannabinoids, including cannabigerol, tetrahydrocannabivarin, and cannabichromene.

Effects Of Caffeinated Green Tea Extract And Exercise In Obese Nzo/Hlltj Mice, Igor Koturbash

Oxford ICSB

Green tea extracts (GTEs) are common ingredients among dietary supplements marketed for weight loss and weight management. However, GTEs and their various catechin polyphenols have also been linked to a number of hepatotoxicity cases. The purpose of this study was to investigate, using the NZO/HlLtJ obese mouse model, the hepato- and cardiotoxic potential of a well-characterized GTE in combination with caffeine (CAF) moderate exercise (EX, 1 hour daily for the duration of 8 weeks) as well as its ability to promote weight loss. No evidence of hepato- or cardiotoxicity was noted when GTE was administered either alone or in combination …

A Randomized, Double-Blinded, Parallel, Placebo-Controlled Clinical Trial To Study The Effect And Safety Of Korean Red Ginseng Extract Powder On Cardiovascular Health Markers In Healthy Adults, Amir Rafie

Oxford ICSB

Cardiovascular disease is a prevalent condition that imposes a significant socioeconomic burden. Korean red ginseng, a medicinal plant traditionally used in Asia, has been suggested to potentially protect against cardiovascular dysfunction by improving blood flow. We conducted a randomized, double-blind, parallel, placebo-controlled trial to assess the effects of Korean Red Ginseng Extract Powder (G1899) on blood flow and platelet aggregation (primary endpoints) and other cardiovascular health markers (e.g., blood coagulation parameters) in healthy adults. Participants (N=108) were randomized in a 1:1:1 ratio to three groups: high dose (2000 mg G1899 per day), low dose (480 mg G1899 per day), and …

Functional Mushrooms Supplementation As A Prebiotic Fibre Impacting Microbiome Composition, The Gut Metabolome And Impact On The Intestinal Epithelial Barrier Integrity, Julie Daoust

Oxford ICSB

This study aimed to determine if functional mushroom preparation supplementation with Cordyceps militaris mycelium and fruiting body, Ganoderma lucidum mycelium and fruiting body, and a blend of ten species of functional mushrooms could impact gut health. The Ex Vivo model Simulator of Human Intestinal Microbial Ecosystem (SHIME®) has been used to study the behaviour of a human microbiome in response to various factors. The aim of this study was to demonstrate changes in the microbiome after supplementation with functional mushroom preparation and the resulting neuroactive metabolome using the SHIME® model. The endpoints measured were microbial fermentation activity, metabolic fingerprinting, microbial …

Caffeine-Free Plant-Based Nootropics: The Evolving Science And Regulatory Journey Of Alpinia Galanga., Deshanie Rai

Oxford ICSB

Consumer interest in using botanicals as complementary medicine to help address a variety of health benefits is rooted in the traditional use of botanicals to support for example vision performance, joint health, and mental wellbeing. With increasingly busy lifestyles, consumers are seeking ways to support their mental energy. While caffeine is a widely used nootropic, consumers are wary of consuming too much caffeine and/or it’s associated “caffeine-crash” effects, and therefore looking for plant-based nootropic alternates. Plant-derived nutraceutical research is now on the research agendas in academic and industry settings. At OmniActive Health Technologies, we are helping to address consumer health …

South African Plants With Potential Applications In Traditional Medicine For Wound Healing, Salome Mahlo

Oxford ICSB

Skin infections are primarily fungal and bacterial attacks on the skin. The aim of the study was to investigate medicinal plants used for the treatment of wound infections by the local people and traditional health practitioners. An ethnobotanical survey was conducted in the Greater Tzaneen Local Municipality, Limpopo Province to identify plant species used to treat skin infections. Guided fieldwork and a semi-structured questionnaire were used to gather information from the traditional healers. A questionnaire was designed to gather information on the common names, plant parts used, preparation, administration, and illnesses treated were recorded for each species. In the current …

Publicly Available Online Data From National Adverse Event Reporting Schemes: Observations On Cases Involving ‘Ashwagandha’, Jo Barnes

Oxford ICSB

No abstract provided.

Evaluation Of Potential Hormonal Activities Of Ashwagandha (Withania Somnifera), Guenter Vollmer

Oxford ICSB

No abstract provided.

Ashwagandha: Is It Safe? A Review Of The Clinical Evidence., Thomas Brendler, Elizabeth Williamson

Oxford ICSB

Over the last decade, ashwagandha (Withania somnifera (L.) Dunal, AS) has been brought under increasing scrutiny regarding its safety for the use in food supplements, culminating in a recent recommendation for an Article 8 procedure according to Regulation (EC) No 1925/2006 in the European Union (EU). Once executed, this could lead to a ban of the use as an ingredient in food supplements. One of the regulators’ concerns is the purported lack of clinical safety data combined with evidence for what may constitute a safe daily dose. In this overwiew we assess evidence stemming from 96 clinical trials conducted over …

The Pharmaceutical Quality Of Herbal Medicinal Products And Dietary Supplements – Assessment Of Products From Lavandula Species, Banaz Jalil, Michael Heinrich

Oxford ICSB

Several Lavandula species are important aromatic and medicinal plants with great economic value as phytopharmaceuticals, foods, in perfumery, cosmetics, and aromatherapy. The genus Lavandula comprises 39 species with many hybrids. Over 20 years ago about 400 registered cultivars were recorded (1) , with the three main cultivated species being used to produce essential oils, including fine lavender oil, spike lavender oil and lavandin oil. Lavandula angustifolia Mill. is used traditionally to treat restlessness, agitation, insomnia and intestinal discomfort linked to nervousness (2). For example, Silexan® is a high-quality fine lavender oil licensed as an active ingredient in medicines for the …

Dosage Form Performance Assessment Of Four Commercially Available Turmeric-Containing Dietary Supplements To Inform Clinical Study Design., Bill Gurley

Oxford ICSB

Clinical studies assessing structure-function claims, safety, phytochemical pharmacokinetics, or drug interaction potential of botanical dietary supplements (BDS) often overlook the disintegration and dissolution characteristics of the administered dosage form. Consequently, inadequate disintegration or dissolution profiles may prevent key study endpoints from being met. Given the high cost of clinical research, no study should proceed without first verifying the disintegration and dissolution performance of the selected dosage form. Failure to do so may compromise the study’s validity and render its findings inconclusive. Assessing dosage form performance, particularly in biorelevant media, is a cost-effective strategy that can provide critical insights for optimizing …

Abstract Title: What Is Chaga? Unique Biochemistry Of The Sterile Conk., Anna Kreynes

Oxford ICSB

Fungal based supplements or functional mushrooms are growing in popularity worldwide. Among them, Chaga is attracting increasing attention for its broad immune-modulatory and anti-inflammatory properties. Chaga is unique among “mushroom” supplements as it is technically neither a mushroom (fruiting body), nor a sclerotia, as some researchers assert, but rather a sterile conk or canker that forms on trees, infected and colonized by mycelia of the pathogenic fungus Inonotus obliquus. Commonly associated with birch (Betula spp.), I. obliquus also parasitizes other hardwood species such as alder (Alnus), beech (Fagus), and ash (Fraxinus), found in boreal forests of northern Europe, Asia and …

An Update From The U.S. Drug Induced Liver Injury Network And Plans For Sentinel Surveillance For Supplement Induced Liver Injury, Victor Navarro

Oxford ICSB

Herbal and dietary supplements (HDS) are commonly used by consumers, and some have been linked to liver injury severe enough in some cases to result in transplantation and death. The U.S. Drug Induced Liver Injury is funded by the NIH to study liver injury from supplements. The DILIN investigators have identified many supplements linked to liver injury, as well as risks for the development of hepatotoxicity. The Network has also observed temporal trends in the occurrence of supplement related liver injury, some that parallel regulatory actions. In order to use these observations to promote consumer protection and supplement safety, the …

Misidentification Remains Common In Selected Historically Substituted Traditional Chinese Medicine Herbs., Wendy Applequist

Oxford ICSB

Various studies have observed that some minimally processed botanicals sold for use in Traditional Chinese Medicine are adulterated or substituted with species having similar appearance and/or traditional uses. In this study, commercial samples of several plants for which aboveground parts are used, and for which Leon & Lin’s (2017) reference work reported known substitutes, were examined. All samples of Ma Chi Xian (Portulaca oleracea), Yi Mu Cao (Leonurus japonicus), Ze Lan (Lycopus lucidus), and Zi Hua De Ding (Viola philippica) were at least mostly consistent with the stated identities, though some contained contaminants. Three of nine samples of Xi Xian …

Supplement Product Quality Woes: A Call To Action, Andrew Shao

Oxford ICSB

No abstract provided.

Digitization Of Hptlc Chromatograms For Chemometric Analysis, Menglian Zhang, Jianghao Sun

Oxford ICSB

HPTLC has been a major analytical tool for the botanical industry for many years. Its strength has been the ability to provide multiple chromatograms for parallel visual comparison of standards and samples. It’s weakness has been the lack of digitization to allow objective chemometric analysis of the data. Two studies are presented: analysis of 3 species of Echinacea (E. angustifolia, E. palida, and E. purpurea) and analysis of cranberry supplements, fruits, and juices (35 supplements, 8 dried fruits, and 4 juices). Accurate comparison of the patterns of the chromatograms required pre-processing: removing initial and final peaks, derivatization, alignment of samples …

Simultaneous Botanical Identification And Marker Compound Assay By High Performance Thin Layer Chromatography, James Kababick, Stacy Wise, Christine Goularte

Oxford ICSB

21 CFR part 111 (the Dietary Supplement cGMPs) require identity testing on all dietary ingredients. In many cases, botanicals are also standardized to selected marker compounds and require potency testing to ensure products meet label claim. We present a novel approach to combining the identification and assay testing into one analytical run utilizing High Performance Thin Layer Chromatography. The method eliminates the need for subsequent assay testing and greatly reduces chemical waste in the laboratory saving both time and money. Case studies will be presented.

Foraging For Methods: The Right Hptlc Method For The Right Spec, Khanh Tran, Sidney Sudberg, Anthony Fontana

Oxford ICSB

High Performance Thin Layer Chromatography (HPTLC) is a well-established analytical technique widely utilized for botanical and fungal identification. Mushrooms are known for their bioactive compounds (beta-glucans, sterols, and triterpenoids) that can have a wide range of human health benefits, such as boosting the immune system, antioxidant, and anti-inflammatory among others. The method selection for mushrooms is dependent on the species of mushroom, the compound(s) of interest, form of material, as well as standardization of extracts. Over 15 different mushroom species were analyzed by various methods by HPTLC, for both mycelia and fruiting body.

Rooted In Quality: Elevating Standards In Botanical Supplements, Katie Banaszewski

Oxford ICSB

The botanical supplement industry is currently navigating a landscape that demands an unwavering commitment to high standards of quality, transparency, and sustainability. This sector faces a host of challenges alongside new opportunities, particularly emphasizing the vital role of quality assurance in preserving the integrity of botanical products. To ensure the authenticity of botanical ingredients and safeguard consumer health, advanced scientific testing techniques have become indispensable. Methods such as DNA barcoding, mass spectrometry, and NMR spectroscopy play crucial roles in verifying the purity and identity of these natural products. Furthermore, as the market increasingly prioritizes ethical consumption, there is a growing …

Innovative Integration Of Hptlc And Ai For Detecting Adulteration And Ensuring Quality In European Elder Berry Products, Maria Monagas, Wilmer Perera, Roy Upton, Eike Reich, Tiên Do

Oxford ICSB

European Elder berry, Sambucus nigra L. has a long history of traditional use as a cold and flu remedy. Since COVID-19 pandemic, the increased demand and limited supply have increased adulteration risk. Major concerns related to adulteration are substitution of Elder berry with black rice extract, addition of synthetic dyes and species mislabeling. HPTLC analysis of a total of 167 samples from different types of ingredients marketed as containing S. nigra was conducted, including whole fruits, juice concentrates, dry juices, fruit powders, liquid extracts, aqueous extracts and Dietary Supplements (DS) products (capsules and syrups). Related species (S. cerulea, S. canadensis, …

Herbs In Commerce: Sales Trends And Consumer Attitudes In The $13 Billion U.S. Herbal Supplement Market, Bill Giebler

Oxford ICSB

No abstract provided.

The Cruciality Of Early Recognition Of Postpartum Depression In Neonatal Intensive Care Unit (Nicu) Mothers, Shelby Clark

Scholars Week

Postpartum depression is a serious complication of childbirth that is largely dismissed by society for a variety of reasons. Unfortunately, the condition is intensified for NICU mothers. If left untreated, postpartum depression can have detrimental effects. This quality-improvement project focused on early recognition of postpartum depression symptoms in mothers of infants admitted to a neonatal intensive care unit in Western Kentucky. The goal of the project was education for and recognition of postpartum depression in NICU mothers. Methodology for the project included utilizing the Edinburgh Postnatal Depression Scale to determine the severity of symptoms of postpartum depression for NICU mothers. …

Improving The Rates Of Sexually Transmitted Infection Diagnosis By Increasing Provider Knowledge About Testing, Lauren Cunningham

Student Scholarship & Creative Works

There has been a significant increase in sexually transmitted infection rates since 2021. Though this issue is nationwide, rural providers require education regarding testing, screening, and transmission of disease processes. The infections with the most significant increase being gonorrhea, chlamydia, and syphilis. The purpose of this project was to provide education to providers regarding local statistics, in addition to when to and not to test for sexually transmitted infections. Education was given to three Advance Practice Nurse Practitioners on disease signs and symptoms, transmission, and local STI statistic rates. STI testing rates were observed three months prior to an educational …

Cultural Linguistic Bias In Language Assessments For Children, Madison Wester

Spring Showcase for Research and Creative Inquiry

Cultural linguistic bias is present in almost all language assessments for children, such as the Preschool Language Scales (PLS-5) and the Clinical Evaluation of Language Fundamentals (CELF-5). Cultural linguistic bias is bias against those who speak a different dialect, such as African American Vernacular English or Appalachian English. Bias in these assessments leads to over-diagnosing children with language disorders, which is harmful in a number of ways. To decrease this bias, SLPs should take a language sample to assess a child’s natural language. However, this process can be time-consuming, which is why the use of online tools, such as SUGAR, …

Empowering Staff Wellbeing: A Team-Based Qi Initiative, Rebecca Lauren Smith, Elizabeth Morse, David Phillippi

SPARK Symposium Presentations

Project Title: Empowering Staff Wellbeing: A Team-Based QI Initiative

Keywords: Burnout, wellbeing, DNP, primary care, QI methodology

Background and Rationale: The consequences of burnout in healthcare are alarming: worse patient outcomes, lack of continuity of care, higher turnover, and increased cost to employers. Many studies of burnout and wellbeing of clinicians focus on larger institutions such as hospitals and Federally Qualified Health Centers. Over the past several years, burnout has been discussed among our small, eight-person clinician team working in a small, non-profit primary care clinic. Yet, there has been no formal assessment of the level of burnout among …

Enhancing Quality Of Life Through Participant-Led Programming For Adults With Intellectual Disabilities, Hannah Bolton

Entry-Level Occupational Therapy Doctorate - Doctoral Capstone Symposium

There are currently over 6.5 million Americans living with an intellectual disability (Centers for Disease Control and Prevention [CDC], 2019). Research shows that individuals with intellectual disabilities are more likely to experience a lower quality of life (QOL) compared to those without disabilities (Hughes-McCormack et al., 2017). Eight core domains have been identified as essential to quality of life: emotional well-being, interpersonal relationships, material well-being, personal development, physical well-being, self-determination, social inclusion, and rights (Lachapelle et al., 2005). In response to these needs, this capstone project aimed to implement customized, supported, participant-led programming at a day program for adults with …

Educational Resource Development For College Students With Intellectual & Developmental Disability:A Focus On Adls And Mental Health, Regan Fosmire

Entry-Level Occupational Therapy Doctorate - Doctoral Capstone Symposium

This Occupational Therapy (OT) Doctoral Capstone project was completed in a university-based Inclusive Post-Secondary Education (IPSE) program serving enrolled students with intellectual and developmental disabilities (IDD). These programs offer college students with IDD opportunities in academic learning, independent living, personal development, career training, and social participation. In response to a site needs analysis, this quality improvement project sought to develop educational resources to improve student confidence and preparedness for independent living and mental health education.

The project had two primary goals: (1) to create accessible, evidence-based educational materials to support students’ understanding of mental health and activities of daily living …

Sensory Processing And Intervention In The Pediatric Setting: Resources For Implementing Sensory Strategies In The Pediatric Outpatient Clinic, Community, And Among Different Diagnoses, Sophia Evatt

Entry-Level Occupational Therapy Doctorate - Doctoral Capstone Symposium

Sensory Integration is such an important concept as sensory processing underlies all independent functioning (Miller et al., 2017), and it is particularly important for pediatric occupational therapists as sensory processing differences are especially common in pediatric populations (Ahn et al., 2004; Leekam et al., 2007).

The purpose of this capstone project is to facilitate occupational therapy clinician competence and confidence in implementing sensory strategies and techniques within an outpatient pediatric clinic that provides in-clinic and community-based services. Project goals include the creation of educational materials in order to improve confidence and to facilitate creativity when incorporating sensory strategies into treatment …

Expanding Health Literacy Among Community-Dwelling Older Adults: Developing And Delivering Educational Sessions, Mary H. Lambert

Entry-Level Occupational Therapy Doctorate - Doctoral Capstone Symposium

Older adults face numerous challenges in maintaining their health and independence, often due to limited access to health information that supports aging in place. This capstone project was executed in a community-based setting catered to older adults and focused on increasing health literacy to promote independence and overall well-being. Through interactive educational sessions, the project aimed to enhance participants’ understanding of key health topics relevant to their daily lives.

The overarching goals of this project were to provide accessible, engaging, and practical health education to older adults, empowering them to make informed decisions about their health. Specifically, the sessions addressed …