Clinical Research Directory

Mushrooms, Mood and Mental Wellbeing in Gen Z Women

The aim of the study is to investigate the effects of 28 days supplementation of Lions mane mushroom and mushroom blend of Lions mane and reishi mushroom, on wellbeing in stressed or anxious women. The study will follow a randomized, double-blind, placebo-controlled, parallel group design. Participants will receive either lion's mane mushroom mane (1.8 gram per day, consisting of 3 x 600mgcapsules), a blend of lion's mane mushroom and reishi mushroom 1.8 gram per day, consisting of 3x600mg capsules) or placebo (1.8-gram microcrystalline cellulose placebo powder, 3x600mg capsules). The trial will utilise Generalised Anxiety Disorder Assessment (GAD-7); the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS); Chalder Fatigue Scale; Rosenberg's Self-Esteem Scale; Perceived Stress Scale (PSS) and Stress Visual Analogue Scales (S-VAS) at baseline and after 28 days supplementation. Participants will complete the HADS and S-VAS at home on days 7, 14 and 21. On day 42 (14 days after treatment ending) participants will complete the GAD-7, HADS and S-VAS. 135 healthy women (who self-report being stressed and/or anxious) aged 18-26 (and born between 1997 and 2013) will be recruited using opportunity sampling. Participants will be supplied with either one of the active treatments or the placebo (allocated by a randomised schedule) whilst visiting the research centre for the testing appointments and will take treatment home to consume daily for the duration of the study. Participants will record time of taking treatment each day in a treatment diary which will be returned to the research centre, along with any unused treatment, upon completion of the study.

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

BabaCare: Testing a Care Copilot

Baba is a novel AI "care copilot" designed to improve emotional well-being, cognitive stimulation, and social connection through emotionally present conversations, proactive engagement, and personalized communication. Unlike many existing solutions, Baba operates through SMS text and voice calls, requiring no apps, Wi-Fi, or new devices, making it particularly accessible to older adults.

Intern Health Study 2026

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.

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.

Investigating the Effects of Dietary Phospholipids on Measures of Human Brain Health and Psychological Wellbeing

The aim of this study is to investigate the effects of 6- and 12-week supplementation of a bioactive whey protein concentrate drink containing dairy phospholipids on cognitive function and mood in healthy young to middle aged adults. The proposed randomised, double blind, placebo-controlled, parallel groups design methodology will assess the cognitive, mood and lifestyle effects of 40g per day of bioactive whey protein concentrate powder mixed with water and matched placebo prior to (baseline) and after -6 and 12-week supplementation. The trial will utilise the COMPASS cognitive assessment system (Northumbria University) during the laboratory visits to measure performance on the cognitive tasks and a range of mood measures between visits examining general mood, stress, depression, anxiety, sleep quality, fatigue, and physical symptoms. Additionally, dairy dietary habits will be recorded throughout to allow for any significant changes to diet to be assessed for the potential influence on the outcome variables. Participants will be asked not to make any major changes to their diet or exercise regime for the duration of the trial. This will be checked by asking the participant if there has been any significant changes at each visit. Blood samples will also be taken from a subset of participants who opt into this part of the trial to measure any changes to plasma phospholipid profiles. 220 participants will participate, aged 25-49, and self-report as in good health. Participants will be supplied with the treatment whilst visiting the research centre on testing days and will then consume treatment at home daily. Participants will record the time they take their treatment each day in a diary that will then be returned to the research team at the end of the study testing period.

THE EFFECT OF REIKI APPLIED DURING THE POSTPARTUM PERIOD ON THE QUALITY OF POSTPARTUM RECOVERY, COMFORT AND MOOD.

The postpartum period, also defined as the fourth trimester of pregnancy, encompasses the approximately 6-8 week period following childbirth, during which the organs that underwent changes during pregnancy return to their previous state. This period is of great importance in terms of protecting the health of both mother and baby, meeting their care needs, and increasing their comfort. During the postpartum period, women experience physiological, psychological, and social changes; hormonal changes, assuming parental roles, changes in family dynamics, and increased responsibilities related to infant care can lead to adjustment difficulties. This can cause problems for the mother in both her own care and infant care. In the postpartum period, mothers may experience various health problems such as pain, fatigue, sleep disturbances, infections, breastfeeding problems, hemorrhoids, constipation, urinary incontinence, depressive symptoms, and mood swings. Pain, in particular, arises due to uterine contractions, breast engorgement, nipple tenderness, and other complications, negatively affecting the mother's mobility, sleep patterns, social interaction, and quality of life. Furthermore, stress and adjustment problems experienced during the postpartum period can lead to serious psychological problems such as delayed maternal bonding, postpartum blues, postpartum depression, psychosis, and communication problems between couples. Pharmacological and non-pharmacological methods are used in the management of these problems. However, due to the negative effects that pharmacological methods may have during breastfeeding, interest in complementary and alternative medicine practices has increased. Reflexology, aromatherapy, music therapy, acupressure, and Reiki are among these methods. Reiki is an energy therapy method that aims to balance an individual's life energy and support the natural healing process, applied through touch or the placement of hands on specific points. Reiki application is reported to have positive effects on pain, stress, anxiety, sleep quality, and coping skills. Although it is one of the preferred methods for adapting to changes and reducing problems experienced in the postpartum period, studies directly examining the effects of Reiki application on postpartum recovery quality, comfort, and mood are quite limited. Due to its low cost, ease of application, and lack of side effects, Reiki is considered an important complementary care approach that can be used in the postpartum period. The aim of this study is to determine the effect of face-to-face Reiki treatment on the quality of postpartum healing, comfort level, and mood in women who have had cesarean deliveries, on days 1, 2, and 7 of the postpartum period.

Psilocybin Efficacy With or Without Pimavanserin Pretreatment

Twenty healthy adults (≥21 years old) will be enrolled to evaluate the efficacy of a single oral dose of psilocybin (25 mg) administered with or without pretreatment using oral pimavanserin (34 mg) or placebo. Outcome assessments will occur at 1 week and 1 month following psilocybin administration. The purpose of this study is to clarify the receptor-level mechanisms underlying psilocybin's effects on mood and well-being, along with the associated neurophysiologic signatures. These mechanisms will be examined using psychometric scales, autonomic and fMRI-based neurophysiologic markers, and integrated pharmacokinetic/pharmacodynamic modeling.

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

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.

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.

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.

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.

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

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.

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.

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

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.