Clinical Research Directory

Examining Effects of Active Plant Engagement on College Student Well-Being and Performance

The goal of this feasibility study is to determine if active engagement with plants (e.g. care, maintenance) improves mental health and academic performance in college students. The main questions it aims to answer are: 1. Does active engagement with plants result in improvements in academic motivation and study habits? 2. Does active engagement with plants result in reductions in stress and improvements in mood? Researchers will compare two interventions groups (campus plant engagement group and home plant engagement group) to the comparison group (no plant engagement or passive exposure) to clarify the practical and potential benefits of active plant care for college students. Participants will: * Complete four surveys over the course of a 16-week semester * Water, prune and check the soil of their assigned plants

PURSUIT: A Technologically Augmented School-based Program to Improve Child Coping and Prevent Substance Use.

The study investigators aim to test an online support platform for Michigan youth aged 8-18 years enrolled in elementary, middle, or high school and their parent/caregiver. The online support platform will be hosted on the Computerized Intervention Authoring System (CIAS) 3.0 and will provide evidence-based cognitive behavioral coping skills for physical (pain) and mental (stress, mood) health symptoms, with additional substance use prevention content for youth aged 12 and older. Evaluations will occur at baseline and then a post assessment approximately 8 weeks later.

Effects of a Collagen Supplement on Quality of Life, Appetite and Glycaemic Control

This is a clinical trial aimed to investigate if a collagen supplement can improve quality of life, appetite and blood sugar in overweight and obese adults aged 18-65. Hypothesis: Consumption of a collagen supplement for 8 days will improve quality of life and improve glycaemic control in comparison with a placebo in individuals overweight or with obesity with a perceived low quality of life. Participants will be asked to: 1. Consume a collagen peptide supplement for a total of 8 days at a time 2. Fill in questionnaires about quality of life, appetite, mood and energy 3. Wear continuous glucose monitors

Exploring the Cognitive Benefits of a Blackcurrant-Based Supplement in Normobaric Hypoxia

This study investigates the cognitive effects of Ārepa, a blackcurrant-based drink, under simulated high-altitude conditions (4,500m normobaric hypoxia for \~180 minutes). Using a double-blind, randomised, placebo-controlled crossover design, participants will consume either the nootropic blackcurrant-based drink or a taste-matched placebo. Cognitive testing (\~80 minutes) includes Trail-making, Stroop, N-back, Serial 7s/3s, and RVIP tasks. Physiological measures (heart rate, SpO₂, blood) and biomarkers (MAO-B, BDNF, hsCRP, S100B, Prolactin, C3G, Sarmentosin) will be assessed. Scales will evaluate mood, wellbeing, and perceived effects. The aim is to determine if the nootropic drink can support cognitive function in hypoxic environments.

Diet, Food, Exercise and Nutrition During Social Distancing

Our long-term goal is to contribute to the development of evidence-based nutritional and physical activity recommendations for the prevention and management of overweight and obesity and related chronic diseases. The overall objective for this study is to determine if a 20-week educational program, project DFEND, related to behavior change and health will improve nutrition and physical activity outcomes as well as indicators of wellbeing. Our central hypothesis is that regular attendance of weekly lectures, weekly meetings with personalized coaches, and weekly health challenges via virtual platforms (e.g. Zoom, Facebook, YouTube) will improve health outcomes related to nutrition and physical activity. Our rationale for these studies is that the results of this research will enhance the potential to develop evidence-based nutritional and physical activity behavioral recommendations to treat and/or prevent development of overweight and obesity.

Physiological and Mood Changes After Walking in Green Spaces. A Comparison of Environments.

Natural environments, and more specifically forest environments, have shown in the last decade a growing interest as a protection against the frenetic pace of life of a large part of the urban population in developed countries, where symptoms related to stress and anxiety are associated with an increasingly frequent state of sub-health. The investigators propose to perform a randomized crossover study to analyze the effects of a walk in the forest on physiological and psychological markers related to autonomic nervous system activity in healthy adult. In addition, the investigators intend to observe whether the characteristics and perceptions of the forest environment could affect the results obtained in these markers using a scale created for this purpose. Participants will be healthy adults with no history of serious physical or psychological illnesses, who will be exposed to three forest environments. Physiological markers will be measured, including heart rate variability, which will be measured with a heart rate sensor that will monitor data throughout the exposure period, and heart rate and systolic and diastolic blood pressure, which will be measured with an automated device before and after each exposure. Before and after the walk through each of the forest environments, mood will be measured using the POMS scale, and our scale will be used to measure the perceived environmental quality after exposure to each environment. In addition to the walk through the three forest environments, a control environment on an indoor treadmill will be used as a comparator, where distance, slope and walking speed will be adjusted to replicate the intensity and physical demand of the three outdoor routes. The four interventions will be organized to create three different exposure sequences. Each exposure sequence will be randomly assigned to a different group. In turn, each participant will be randomly assigned to one of the three groups, so that all participants will undergo all four interventions in a repeated measures design. Our hypothesis supports the idea that exposure to forest environments causes changes in physiological parameters and mood associated with positive regulation for health and for the autonomic nervous system in healthy adults compared to a neutral non-forest environment. As a second hypothesis, environmental characteristics as well as the perceived quality of the forest environment would be related to the magnitude of such changes associated with autonomic nervous system regulation and mood in healthy adults.

Effectiveness of Microdosed GLP-1 in Improving Health, Quality of Life, and Longevity Measures

The goal of this clinical study has two objectives. The Primary Objective is to evaluate the effectiveness of microdosed GLP-1 receptor agonists in improving measures of health, quality of life, and longevity. The Secondary Objective: To assess the impact of these therapies on weight management practices and metabolic health.

Combined Blood Pressure Medication and Activity Scheduling for Low Mood

This study explores the effects of 7-day losartan (50mg) versus placebo with brief behavioural activation on emotional processing in young volunteers low in positive mood

Developing Resilience and Anxiety Management Through the Arts

The Developing Resilience and Anxiety Management Through the Arts (DRAMA) Study examines the degree to which the arts can help to address stress, anxiety, and sad mood in children and adolescents. The researchers will pair theatrical improvisation exercises with cognitive-behavioral therapy (CBT) techniques versus improvisation exercises alone versus a social craft group on reducing elevated levels of anxiety and depression.

Intern Health Study 2025

The aim of this study is to evaluate the efficacy of using a reinforcement learning algorithm to determine the optimal content of a mobile health intervention (message delivered via smartphone) for improving the mood, physical activity, and sleep of medical interns.

Investigation of the Acute Effects of Nepalese Pepper Extract (Zanthoxylum Armatum DC) on Cognitive Function, Mood and Gaming Performance in Young, Healthy, Competitive Gamers

The goal of this clinical trial is to learn if a Nepalese Pepper Extract (Zanthoxlum Armatum, ZA) supplement can improve cognitive performance and mental abilities in competitive gamers aged 16 to 34. The main questions it aims to answer are: 1. Does ZA supplement improve cognitive abilities like attention, memory, and decision-making? 2. What is the most effective dose of ZA supplement (300mg vs 150mg)? 3. How do the effects of ZA supplement compare to caffeine? Researchers will compare four different treatments (high-dose ZA, low-dose ZA, caffeine, and placebo) to see if ZA supplement produces better cognitive performance than placebo and how it compares to caffeine\*\*. Participants will: * Complete a screening visit with health checks and training on computer tasks * Attend four testing visits (7-14 days apart) where they receive different treatments * Avoid alcohol and energy drinks for 24 hours before each visit, and caffeine from waking * Take assigned treatment at 11:30am and complete cognitive tests at -1, 1, 3, and 5 hours in relation to dose. * Complete mood questionnaires, sleep assessments, and gaming-specific tasks (aim training, character control) * Wear heart rate monitors during testing * Eat standardized meals provided during visits * Play competitive games at home in the evening and complete performance questionnaires

Use Muscadine Wine Nutraceuticals to Improve Brain Health, Cognition, and Mental Health

Previous studies have shown that polyphenol-rich foods can positively affect cognitive functions, memory, and mood in humans. We hypothesize that both acute and chronic intake of muscadine wine polyphenols will improve cognitive performance and mood through regulating the HPA axis, alleviating inflammation and oxidative stress, and/or inhibiting monoamine oxidase activities

Acute Cognitive Effects of Brain Edge

A double-blind placebo-controlled crossover study exploring the cognitive effects of Brain Edge; a supplement consisting of a blend of herbs and amino acids. 50 healthy adult subjects will be evaluated over 3 sessions. Evaluation of cognitive performance will be determined by computer-based software, surveys, and VR headset experiences.

Effect of Black Cumin Seed Oil Supplementation on Cortisol, Stress and Mood

The primary objective of this study will be to collect data to support the role of black cumin seed oil, also known as black seed oil (BSO), in moderating the stress response, including objective markers of stress (cortisol/DHEA) as well as subjective measures (mood/stress/sleep/beauty). The primary outcomes will be salivary cortisol, subjective stress, and psychological vigor. Subjects will be recruited from among the clients of the Certified Mental Wellness Coaches (CMWCs) that have passed the digital badge course via Marietta College (https://www.credly.com/org/marietta-college/badge/certified-mental-wellness-coach-cmwc-online). If volunteers meet the inclusion/exclusion criteria, they will review/sign the Informed Consent Form (ICF - attached) before any Baseline measurements are collected. Because BSO is already known to deliver a wide range of potential health benefits, including anti-inflammatory, anti-oxidant, anti-diabetic, and immune-modulating effects - we expect to observe improvements on both subjective psychological and objective biochemical measures. Our primary outcome measures will be salivary cortisol and psychological mood state (POMS, including tension, mood, irritability, focus, fatigue, vigor and well-being).

The Effect of Portion Sizes on Mood

The purpose of this study is to investigate whether different portion sizes will effect overall mood.

Impact of Bright Light Therapy on Prader-Willi Syndrome

This is a placebo controlled clinical trial to assess the utility of light therapy as a sufficient treatment for excessive daytime sleepiness in patients with Prader-Willi Syndrome

Investigating the Acute and Chronic Effects of a Supplement Containing Caffeine, Vitamins, Minerals and Botanical Extracts on Cognition, Sleep and Wellbeing, in Healthy Volunteers

The aim of the study is to investigate the acute and chronic effects of a supplement containing Caffeine, Vitamins, Minerals and Botanical extracts on cognitive function, sleep and wellbeing, in healthy volunteers. The study will follow a randomised, double-blind, placebo-controlled, crossover design. Participants will receive both treatments, and both study arms will include an acute testing visit (day 1) and a chronic testing visit (day 29). The active treatment contains a blend of 120mg caffeine, vitamins, minerals and botanical extracts and the matched placebo treatment contains marigold extract and brown rice flour. The trial will use computerised cognitive tasks, administered via COMPASS software (Northumbria University, UK), online cognitive assessments via Cognimapp and self-reported questionnaires and sleep diary, as measures of the outcome variables. 90 participants will participate, aged 18-75, and self-ported as being in good health. Participants will be randomly allocated to a treatment order and will be supplied with either the active treatment or the placebo whilst visiting the research centre for the acute testing visits. Participants will take the treatment home to consume daily for the duration of the supplementation period. Participants will record the time of taking treatment each day in a treatment diary which will be returned to the research centre, along with any unused treatment, at each chronic testing visit.

Technology Exposure and Child Health: Wellness Impact and Social Effects: an Observational Product Registry Study

The goal of this study is to understand how children's mobile device usage (smartphones or tablets), including social media use and online games, are related to their mental wellness and mental health, as well as some aspects of their physical activity and sleep. This study is available to all children between the ages of 8 and 17 years and a parent/caregiver. Researchers will compare participant mobile device usage with their survey responses on sleep, stress, mental health, and physical activity, as well as their parent/caregiver's survey responses. Participants will: * run the Aura app with parental controls on their dedicated mobile device * complete monthly surveys * answer daily questions on mood, stress, sleep and physical activity The study is fully virtual. Duration is 3 months.

Efficacy and Safety of Shatavari for Treatment of Menopausal Symptoms in Women: A Randomized, Double-blind, Three-arm, Parallel, Placebo-controlled Study

This is a Multi-center, Multi-national, Prospective, Randomized, Double-Blind, Placebo- Controlled three arm study to evaluate the efficacy and safety of Shatavari for the treatment of Menopausal symptoms in Women. Participants will be randomized to either one of the three treatment arms.Participants will then be asked to either take one capsule containing Shatavari or Shatavari + Ashwagandha or Placebo orally once daily in the morning after breakfast with a glass of water for 8 weeks. All the subjects will be asked to continue their routine diet and physical activities during the whole study period. The primary objective is to compare the efficacy of shatavari for treatment of menopausal symptoms in women. The secondary objective is to compare the safety of shatavari for treatment of menopausal symptoms in women.

Student Exercise and Sleep Timing Study - Part 2

The purpose of this study is to examine the effects of a morning exercise intervention on sleep (quality and duration), mood (positive affect, anxiety, depression, anger), stress and productivity among undergraduate students (18-23 years) evening-exercisers with poor self-reported sleep quality. Aim 1. Compared to the control condition, evening-exercisers prescribed morning exercise will exhibit improved sleep quality (increased efficiency, decreased fragmentation) and increased sleep duration. Aim 2. Compared to the control condition, evening-exercisers prescribed morning exercise will exhibit improved mood (increased positive affect, decreased depression, anxiety and anger). Aim 3. Compared to the control condition, evening-exercisers prescribed morning exercise will exhibit decreased stress and increased productivity.

Contraceptive Hormone and Reward Measurement (CHARM Study)

Purpose of this study: The purpose of this study is to learn more about how hormonal oral contraceptives affect brain processes and emotional wellbeing. Procedures: If participants agree to participate, the following will happen: 1. Eligibility visit (remote screening session) 2. If participants are eligible to participate in the study, they will be placed in one of two groups. If they are in the first group, they will be asked to take an oral contraception pill ("study drug") every day for 21 days. If they are in the second, they will take a placebo every day for 21 days. A placebo is a pill that looks like medicine but is not real and will have no medical effect on participants. Participants will not get to choose which group they are in, nor will they be told which group they are in. 3. During the three-week period in which participants will take either the study drug or placebo, they will be asked to complete daily check-in surveys on their computer or mobile device. 4. Participants will be asked to attend two additional visits over the course of about three weeks. At these visits, participants will be asked to undergo a urine drug screen, a blood draw, and a magnetic resonance imaging (MRI). They will also be asked to complete behavioral questionnaires.

Effects of Diet on Perinatal Mood and Cognition

The baby blues are a significant event which can occur immediately following childbirth and is a normal experience occurring in up to 76% of new mothers, characterised by mood swings, irritability and sadness typically lasting 10-14 days. Research suggests that the more severe and longer duration of the baby blues, the higher risk of later postnatal mood disorders. Therefore, this represents a critical period which could benefit from an intervention which may prevent symptom onset or an increase in the severity of mood disorders later in the postpartum. Evidence suggests that consumption of flavonoid rich foods can improve physical health, mood and cognition. Prior research investigating flavonoid intervention in mothers in the first 6 months and 1 year postpartum found significant benefits to mood in the new mothers after daily flavonoid supplementation, showing promise for the management of mood in a key period for mothers, where risk of Postnatal Depression (PND) is high. The immediate postpartum also represents a period of cognitive changes reported to affect up to 80% of new mothers. In addition, women during this time are at an increased risk of high blood pressure and hypertension, which is thought to be a risk factor for the onset and severity of depressive symptoms and cognitive decrements. Flavonoids have been reported to improve cognition and cardiovascular health, therefore, introducing a flavonoid intervention could have benefits to cognition and blood pressure in new mothers. The aim of the current study will be to explore whether the implementation of a high flavonoid diet across a 30-day period will positively affect maternal mental health, cognition and blood pressure. Participants will be assigned to one of three groups; high or low flavonoid diet or a control condition for 30-days, starting at days 0-4 after birth. They will have visits from the researcher at 6 separate time points between the third trimester and 12 weeks postpartum. At each visit, participants will be asked to complete mood questionnaires (PANAS-NOW), Edinburgh Postnatal Depression Scale (EPDS), Postpartum Specific Anxiety Scale (PSAS), State-Trait Anxiety Inventory (STAI), Edinburgh Postnatal Depression Scale- Partner (EPDS-P) followed by a cognitive battery (MANT, RAVLT, PRMQ) and blood pressure recordings (systolic and diastolic blood pressure). Between visits, participants will be contacted by the researcher to record retrospective 24hr food recalls (Intake24).

Intern Health Study 2024

The aim of this trial is to evaluate the efficacy of an intervention (delivered through a smartphone) for improving the mood, physical activity, and sleep of medical interns.

Research Framework Exploring Sleep Health

This is a digital health study in which participants are recruited to collect sleep and activity data from digital activity trackers. We are also collecting survey/questionnaire data on baseline health and sleep characteristics as well as bi-weekly assessments of sleep quality and mood. Overall, we aim to examine how sleep relates to physical and mental health in a large population of activity tracker users.