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Clinical research

Faculty at the College of Health Solutions are engaged in a wide variety of clinical research to improve health outcomes. Studies look at the effectiveness of interventions — including medications, devices, behavior modifications, diagnostic products and treatment regimens — for prevention, treatment and diagnosis that improve quality of life.

Assisted cycle therapy to improve cognitive abilities in children with Down syndrome

Assisted cycle therapy to improve cognitive abilities in children with Down syndrome

Shannon Ringenbach

The objective of this study is to develop a pediatric version of the current adult-sized bicycle used for Assisted Cycle Therapy (ACT) with modifications for the smaller bodies of young children, laying the foundation to translate findings to broad clinical applications and early interventions. This study also aims to pilot test the effectiveness of the pediatric theracycle on young children with Down syndrome. The innovative strategies utilized in this project lie in both the mechanical motor in the bicycle and its importance for early intervention in pediatric neurologic populations.

Attention and balance in people with Parkinson’s disease

Attention and balance in people with Parkinson’s disease

Dan Peterson

Cognition, and in particular, attention, is negatively affected in people with Parkinson’s disease, and levodopa, a common pharmacological treatment for PD, can have variable effects on this symptom. Further, the ability to focus and divide attention is critical to effectively and safely move through one’s environment. This project seeks to understand how levodopa impacts attention in people with PD, as well as the activity in the brain while completing an attention task. This project will enhance our understanding of how medication impacts a patient's attention (from both neural and behavioral perspectives), and how this relates to everyday balance and attention tasks.

Beneficial effects of maqui berry extract combination with omega-3 fatty acids

Beneficial effects of maqui berry extract combination with omega-3 fatty acids

Carol Johnston

Natural products have been used medicinally for centuries. Anthocyanins, a subclass of flavonoids, are pigments that provide the rich color of many plants, fruits and flowers. Health benefits of anthocyanins have been widely reported in research, particularly for conditions associated with oxidative stress, such as cardiovascular and neurodegenerative diseases. Emerging evidence suggests that anthocyanins may also modulate gut microbiota, which can impact a wide variety of health conditions. Maqui berries (Aristotelia chilensis), indigenous to Chile, have one of the highest concentrations of anthocyanins in the plant world; moreover, the dominant anthocyanin in maqui berries is delphinidin. Delphinidin is more bioavailable than most flavonoids, with intact molecules absorbed in appreciable amounts in less than an hour after consumption. Systemic effects of delphinidin include reduced inflammation due to downregulation of NF-kB, the transcription factor that initiates the generation of pro-inflammatory cytokines. The omega-3 fatty acid eicosapentaenoic acid [EPA], a component of omega-3 fatty acid concentrates, also has anti-inflammatory properties. There is much empirical evidence demonstrating beneficial effects of EPA supplementation, linked mainly to reductions in inflammation. It has been demonstrated that dietary supplementation with EPA-rich marine oil concentrations reduces cytokine levels up to 15%. This trial aims to determine the effect of maqui extract plus omega-3 fatty acids compared to a placebo for reducing inflammatory cytokine levels in older, obese adults.

Blood biomarkers and treatment responses to aerobic exercise and/or cognitive training in amnestic mild cognitive impairment

Blood biomarkers and treatment responses to aerobic exercise and/or cognitive training in amnestic mild cognitive impairment

Fang Yu

This study investigates whether blood tests can track responses to treatments that are aimed to slow cognitive decline and help maximize lifestyle treatment outcomes. This study may also help researchers develop blood tests that can identify those at risk for cognitive decline. This study is supplemental to the main ACT Trial, and thus, only participants who are enrolled in the main ACT Trial are eligible to participate. More information at www.theacttrial.com.

Brain mechanisms of reducing polysubstance use following a novel body-mind intervention

Brain mechanisms of reducing polysubstance use following a novel body-mind intervention

YiYuan Tang

This study aims to address the widespread, critical public health issue of polysubstance use, namely alcohol, tobacco and cannabis in adults, and to investigate brain mechanisms and intervention effects of a novel integrative body-mind training. Study findings will have significant implications for the design of new effective brain-based interventions for addictions related to self-control deficits.

Corn and heart health study

Corn and heart health study

Corrie Whisner

This study aims to use food to lower LDL cholesterol by looking at individuals with mild-to-moderately high LDL who do not want to take medication. Participants are generally healthy with elevated cholesterol (LDL) between the ages of 18-70 years. Interested prospective research participants should take the screening survey.

The effect of metabolic alkalosis on exercise regulation (pacing)

The effect of metabolic alkalosis on exercise regulation (pacing)

Jason Siegler

The ingestion of sodium bicarbonate, or baking soda, prior to competition has been used as a strategy by athletes to minimize the effects of fatigue in the muscle during prolonged, high-intensity exercise. Ingestion of baking soda increases the body’s natural blood buffering capacity by reducing acidosis, the burn you feel in your legs during exercise. Recent research has demonstrated that acidosis in the muscle also stimulates nerve fibers responsible for alerting the brain. Theoretically, if sodium bicarbonate was introduced to reduce the acidosis experienced by the muscle, this might also reduce the signaling rate of these fibers and ultimately affect motor drive back down to the working muscle from the central nervous system. This research study aims to investigate whether reducing acidity in the muscle can delay this signaling cascade and increase the body’s ability to sustain higher force output longer during prolonged, intense exercise sessions.

Effect of two food supplements on proinflammatory markers in adults with COVID-19

Effect of two food supplements on proinflammatory markers in adults with COVID-19

Carol Johnston

Inflammation is at the core of many chronic conditions and exacerbates infectious conditions, and inflammatory responses appear to be key determinants of COVID-19 virus severity. Hence, controlling inflammation is considered a key strategy for slowing the progression of disease. Since inflammation is fueled by anxiety and stress, amplifying the pathophysiology of disease and infection further emphasizes the importance of subduing the mediators of inflammation. This research offers a natural, dietary approach to managing inflammation through the beneficial effects of two food supplements, palmitoylethanolamide (PEA) and curcumin. This study aims to demonstrate the efficacy of these dietary supplements in adults from a college campus population with robust immune protection — those who recently tested positive for COVID-19 but were asymptomatic or mildly symptomatic.

Effects of Vitamin C supplementation on erythrocyte osmotic fragility in individuals with Type 2 diabetes mellitus

Effects of Vitamin C supplementation on erythrocyte osmotic fragility in individuals with Type 2 diabetes mellitus

Carol Johnston

Many symptoms of diabetes are similar to those of scurvy, the vitamin C deficiency disease, and vitamin C deficiency is more prevalent in individuals with diabetes compared to their healthy counterparts. Vitamin C terminology encompasses both the active form of the vitamin (ascorbic acid) and the oxidized (or used) form of vitamin C (dehydroascorbic acid). The oxidized form of vitamin C, dehydroascorbic acid (DHA) and glucose, both enter the erythrocyte via a GLUT receptor because of structural similarities. Once in a cell, DHA is recycled into ascorbic acid. Under conditions of high blood glucose, erythrocytes become ascorbate deficient due to poor DHA uptake. Additional evidence shows that ascorbate deficient erythrocytes are more fragile and susceptible to lysis under conditions of osmotic stress. This project examines whether vitamin C status is related to erythrocyte osmotic fragility in individuals with type 2 diabetes and healthy controls.

Efficacy and mechanism of combined aerobic exercise and cognitive training in mild cognitive impairment

Efficacy and mechanism of combined aerobic exercise and cognitive training in mild cognitive impairment

Fang Yu

This study investigates whether physical and brain training will impact the symptoms of, and delay the progression of, cognitive decline in adults 65-years and older. Participants may engage in various forms of physical exercise and/or brain games/mental activities, will have their cognitive status tested and undergo MRI brain scans throughout the study. More information at www.theacttrial.com.

Examination of the daily ingestion of high protein nutrition bars on satiety

Examination of the daily ingestion of high protein nutrition bars on satiety

Carol Johnston

Few studies have examined the health impact of energy bar consumption, particularly in regards to overall energy intake and satiety. Commercial nutrition bars provide energy and essential nutrients such as protein and fiber, and evidence shows that protein and fiber have the potential to promote satiety and suppress energy intake. Although many studies have found that protein and fiber promote satiety and reduce energy intake in the short term, only a few studies have examined the effects of long-term satiety on body weight. Most of these studies utilized protein and fiber supplements in a liquid form with only one study investigating the long-term impact of energy bars on appetite and energy intake in free-living individuals. However, the effect of commercial energy bars that combine high protein and high fiber (HPHF) on appetite and energy intake remain unclear. This study will examine daily consumption for seven consecutive days of HPHF energy bars compared to high protein energy bars on 24-h energy intake and satiating effects in free-living healthy adults in the Phoenix metropolitan area.

Examining cognitive capacity and oxygen cost in adults with Charcot-Marie-Tooth disease

Examining cognitive capacity and oxygen cost in adults with Charcot-Marie-Tooth disease

Ed Ofori

Research has shown that walking outcomes can be an indicator of performance fatigue in individuals with Charcot-Marie-Tooth (CMT) disease. In this study, participants complete a series of walking tasks, including a 6-min walk test, in order to understand the clinical meaningfulness of the observed changes, which may involve the consideration of physiological variables such as the rate of oxygen consumption. We aim to study whether there are symptoms, such as fatigue, pain and cognition impairment reported by CMT patients that relate to the oxygen cost of walking. Our results could potentially highlight that cadence of walking as a target for rehabilitation for increasing metabolic efficiency for individuals with CMT.

Genetic and neuroimaging markers of adolescent and adult cannabis users

Genetic and neuroimaging markers of adolescent and adult cannabis users

Ed Ofori

Cannabis is the most commonly abused illicit drug in the United States. With legalization of recreational cannabis and commercialization of high potency cannabis products, it is likely that more individuals will be at risk for developing cannabis use disorder. Currently no FDA-approved treatment for cannabis use disorders (CUD) are available. This study utilizes unique tools to examine brain health and brain inflammation to predict decline or relapse. The combination of these tools could lead to new treatments and interventions in individuals with cannabis use disorders.

Metabolic biomarkers for Parkinson’s disease: discovery and initial validation

Metabolic biomarkers for Parkinson’s disease: discovery and initial validation

Dan Peterson

Balance dysfunction and falls are among the most important symptoms in people with Parkinson’s Disease. Being able to predict and track progression of balance dysfunction can improve the ability of clinicians to precisely treat these symptoms. This project seeks to understand predictors of balance degradation in people with Parkinson’s disease. Specifically, we will determine whether changes in voice or cognition predict changes in balance over one year.

Metabolomics diagnosis of Parkinson’s

Metabolomics diagnosis of Parkinson’s

Dan Peterson

Balance dysfunction and falls are among the most important symptoms in people with Parkinson’s disease. Being able to predict and track progression of balance dysfunction would improve the ability of clinicians to precisely treat these symptoms. This project seeks to understand predictors of balance degradation in people with Parkinson’s disease. Specifically, we will determine whether changes in voice or cognition predict changes in balance over one year.

Nitrogen balance and protein intake at the RDA in underactive male vegans

Nitrogen balance and protein intake at the RDA in underactive male vegans

Carol Johnston

Vegan and vegetarian diets have gained in popularity in recent years due to potential health benefits and concerns of animal welfare. Though considered to be nutritionally adequate, questions remain over whether current protein recommendations of 0.8g/kg/d are sufficient to maintain body processes and growth. Protein is unique in that it is the only macronutrient that contains nitrogen. Its status can be determined through nitrogen balance analysis of the urine if protein content of the diet is known. Nitrogen balance is considered the gold standard for determining protein intake requirements. A negative balance indicates a catabolic state, whereas a positive nitrogen balance is seen during anabolism. In healthy people, nitrogen equilibrium is desired under normal circumstances. This equilibrium reflects the net synthesis and breakdown of proteins. While nitrogen balance techniques have been used for decades, currently there are no known studies measuring nitrogen balance and protein intake in vegans. This study aims to determine nitrogen balance in vegan individuals following short-term, structured, eucaloric vegan diets at the protein RDA, 0.8g/kg/d.

Non-pharmaceutical fentanyl use and opportunities for intervention through the expansion of drug checking services

Non-pharmaceutical fentanyl use and opportunities for intervention through the expansion of drug checking services

Raminta Daniulaityte

This Phoenix Health Study focuses on the risks associated with non-pharmaceutical fentanyl use. Non-pharmaceutical fentanyl and other fentanyl-like drugs are highly potent opioids, and they have become the primary drivers of the accelerating overdose crisis in the U.S. We aim to understand how people who use drugs experience and navigate risks associated with the increased presence of non-pharmaceutical fentanyl in the local illicit drug supply. We also aim to utilize lab-based urine toxicology analysis to identify the presence of fentanyl, a broad range of fentanyl analogs and other drugs. Building on the collaboration with Sonoran Prevention Works, a leading harm reduction organization in Arizona, we will obtain data to inform the development of community-based drug checking services to help reduce harms associated with the increasing proliferation of highly potent illicit synthetic opioids, such as fentanyl and others.

OMNI 2

OMNI 2

Carol Johnston

Many vegetarians struggle to eat a substantial diet and get enough protein because plant protein has protein bioavailability that is 10-30% lower than animal protein. Thus, current research suggests that a separate protein dietary reference intake (DRI) is needed for vegetarians that is larger than the protein DRI for meat eaters. This is a major concern because inadequate protein intake can affect bone health and alter muscle mass. The research available on this topic has included strength training as a variable for increasing lean muscle mass. This study examines the effect of supplemental plant protein on strength and lean body mass in adult, non-athletic vegetarians in the Phoenix area. 

Phase 3 trial evaluating the efficacy and safety of cytisinicline in adult smokers

Phase 3 trial evaluating the efficacy and safety of cytisinicline in adult smokers

Scott Leischow

This study assesses the potential of a new medication, cytisinicline, to safely help smokers quit. Cytisinicline is a naturally occurring substance that exists in many plants around the world (including in Arizona), and it works in a way that is similar to varenicline. The importance of this study is that there has not been a new smoking cessation medication approved by the FDA in over 10 years and new approaches are needed to help smokers quit. This study is supported by Achieve Life Sciences and Veristat.

Preventing diabetes in Latino families

Preventing diabetes in Latino families

Gabriel Shaibi

The purpose of this study is to determine if a 16-week, family-focused lifestyle intervention that includes physical activity, nutrition education and behavior change strategies will reduce Type 2 diabetes risk factors and increase quality of life among high-risk Latino families compared to a control group.

Protective step training in people with multiple sclerosis

Protective step training in people with multiple sclerosis

Dan Peterson

Balance dysfunction and falls are among the most important symptoms in people with multiple sclerosis. Developing and testing rehabilitative approaches to reduce falls in this population will enhance the ability of clinicians to treat falls, ultimately improving patient quality of life. This study tests the preliminary effectiveness of slip training to improve balance and reduce falls in people with multiple sclerosis.

Protective step training in people with Parkinson’s disease and postural disturbances

Protective step training in people with Parkinson’s disease and postural disturbances

Dan Peterson

Balance dysfunction and falls are among the most important symptoms in people with Parkinson’s disease. Developing and testing rehabilitative approaches to reduce falls in this population will enhance the ability of clinicians to treat falls, ultimately improving patient quality of life. This study tests the preliminary effectiveness of slip training to improve balance and reduce falls in people with Parkinson’s disease.

Rise for health

Rise for health

Dorothy Sears

Research shows that reducing sedentary behavior may improve health. This research study aims to better understand how extended sitting may impact health by looking at whether short standing or walking breaks help to improve health. The study looks at women 55 years or older who have gone through menopause, are considered overweight and spend a lot of time sitting down each day.

Skeletal muscle protein metabolism in obesity

Skeletal muscle protein metabolism in obesity

Christos Katsanos

A key defect in the metabolism observed in muscle of humans with obesity-associated pre-diabetes is altered expression of proteins responsible for determining the human muscle phenotype. The research seeks to unravel the underlying biology that sustains distorted expression of such proteins in muscles of humans with obesity. Such knowledge is key in order to develop interventions that modify muscle metabolism in humans with obesity and prevent progression to Type 2 diabetes.

Smoking Cessation Study: Varenicline OTC trial on efficacy and safety

Smoking Cessation Study: Varenicline OTC trial on efficacy and safety

Scott Leischow

This study is designed to determine whether the most effective smoking cessation medication on the market, varenicline (ChantixTM), is still safe and effective when used without a doctor’s prescription, such as when it is available in local markets and stores as a consumer product. The importance of this study is that many smokers either don’t have easy access to a health care provider or don’t take the time to visit one, so making such medications more readily available has the potential to help far more smokers quit. Results will be available summer 2022. This study is funded by the National Institute on Drug Abuse (NIDA), which is part of NIH, and medications were provided by Pfizer.

Time 4 health

Time 4 health

Dorothy Sears

This study seeks to understand how lifestyle habits, such as sleep and timing of meals, influence the daily variation of hormones related to metabolic health among Hispanic women who have already passed menopause.

Transcranial direct current stimulation to enhance physical activity behavior

Transcranial direct current stimulation to enhance physical activity behavior

Christos Katsanos

The purpose of this study is to determine the extent to which stimulation targeting the neurobiology of the brain can be used as an intervention to enhance overall daily physical activity in healthy individuals. The importance of this research is based on the well-established health benefits of physical activity, yet only a small number of adults engage in regular physical activity. Subjects receive brain stimulation using transcranial direct current stimulation (tDCS) over a period of a few weeks during which time their physical activity patterns are monitored using a physical activity tracker.

Using remote ischemic preconditioning to improve neural recruitment during resistance exercise after spinal cord injury

Using remote ischemic preconditioning to improve neural recruitment during resistance exercise after spinal cord injury

Jason Siegler

The clinical application of ischemic preconditioning and remote IPC (RIPC) has historically been used in the cardiovascular field to improve surgical outcomes prior to heart procedures. Recently, however, RIPC has been studied in other clinical populations, such as stroke patients as well as healthy individuals, to explore whether this treatment improves exercise performance. Two possible mechanisms appear to be responsible for exercise performance improvements. The first, humoral (in the blood), is more commonly seen in prolonged, strenuous aerobic exercise tasks. The second, and less studied, is the effect RIPC has on improving neural recruitment of skeletal muscle. A recent study has also shown in a spinal cord injury-induced rat model that RIPC improves sensory motor function. Although somewhat related to blood flow restriction training (BFR), RIPC may be more practical and require less oversight during supervised exercise training as the intervention is prior to, and not during, exercise. As such, this research is investigating the effect of RIPC to determine whether this intervention improves neural recruitment and the ability to generate muscle force in people with partial spinal cord injury.

Vitamin C supplementation and RBC hemolysis in Type 2 diabetes mellitus

Vitamin C supplementation and RBC hemolysis in Type 2 diabetes mellitus

Carol Johnston

Many symptoms of diabetes are similar to those of scurvy, the vitamin C deficiency disease, and vitamin C deficiency is more prevalent in individuals with diabetes compared to their healthy counterparts. Vitamin C terminology encompasses both the active form of the vitamin (ascorbic acid) and the oxidized (or used) form of vitamin C (dehydroascorbic acid). The oxidized form of vitamin C, dehydroascorbic acid (DHA) and glucose, both enter the erythrocyte via a GLUT receptor because of structural similarities. Once in a cell, DHA is recycled into ascorbic acid. Under conditions of high blood glucose, erythrocytes become ascorbate deficient due to poor DHA uptake. Additional evidence shows that ascorbate deficient erythrocytes are more fragile and susceptible to lysis under conditions of osmotic stress. This project examines whether vitamin C status is related to erythrocyte osmotic fragility in individuals with type 2 diabetes and healthy controls.

WalkIT adolescent pilot

WalkIT adolescent pilot

Marc Adams

This research aims to help inactive teens improve their physical activity by testing innovative ways of setting activity goals, including earning rewards for meeting goals and motivational text messages. This study will recruit 40 adolescents from Maricopa County to participate in a 3-month intervention. Eligible adolescents will receive an activity watch, text messages each day with exercise goals and positive feedback on their activities, gift cards for meeting goals, and learn about the health benefits of physical activity while contributing to health research. Prospective study participants should complete the recruitment survey.

WorkWell: Increased standing and light-intensity physical activity in prediabetic sedentary office workers

WorkWell: Increased standing and light-intensity physical activity in prediabetic sedentary office workers

Metabolic Translational Team: Matt Buman, Dorothy Sears and Corrie Whisner

This preclinical pilot study looks at how prolonged sitting might impact health by studying men and women at least 18 years old who spend the majority of their work day seated. The goal is to understand how sitting, standing and moving during the workday impacts one’s health.