Clinical Research Directory

ELITE: Deep Profiling and Algorithmic Polytherapy to Map Individual Response in Healthy Aging

ELITE, Evidence-Based Longevity Interventions and Targeted Engagement, was a randomized, open-label, two-active-arm Phase IIa pilot conducted at Sheba Medical Center in Ramat Gan, Israel. The purpose of ELITE was to characterize individual response to multidomain healthy-aging interventions over approximately eight weeks by combining a clinical measure of muscular, immune and cognitive function with frequent digital monitoring between study visits. The primary outcome was change from baseline to Week 8 in the Muscular-Immune-Cognitive Composite (MIC-C). The study hypothesis was that repeated digital measurements could capture the trajectory of individual response over time and relate that trajectory to clinical change measured at Week 8. Prespecified secondary outcomes included safety, study completion and overall protocol adherence. The protocol-defined intervention was algorithmic polytherapy, integrating a multicomponent pharmacologic and investigational-product regimen with longitudinal digital response monitoring and physician-supervised decision support. In this eight-week pilot, randomized treatment assignments remained fixed. Algorithm-derived response states were generated and reviewed by physicians but did not trigger treatment reassignment. ELITE enrolled 31 community-dwelling adults aged 50 to 80 years without diabetes and with a body-mass index of at least 25 kg/m2. Participants were randomized 1:1 to one of two active treatment regimens. Arm A received metformin plus semaglutide, and Arm B received metformin plus empagliflozin. Both groups also received the investigational AgeBiotics products AB-01 and AB-02 as common components of the multidomain intervention. Individual study products could be interrupted or discontinued for clinical or safety reasons under physician supervision. Between clinic visits, participants completed structured assessments through the ANI.AI application, including tongue, left-eye, right-eye, face and wrist imaging, a short micro-survey and a voice recording. Multispectral measurements of the tongue, face and wrist were collected with a dedicated capture device. These repeated digital measurements were integrated with scheduled clinical, functional, laboratory and multi-omic assessments to create a longitudinal view of biological and functional change during treatment. The ANI.AI platform generated a Composite Response Score (CRS/ADAPT Score) from longitudinal digital biomarker data. The CRS tracked change relative to each participant's baseline and was used within a Bayesian response framework with four prespecified states for physician review: KEEP, AUGMENT, SWITCH and STOPP. The study also included a complementary longitudinal digital health composite to characterize broader multidomain change across repeated digital measurements. These digital measures were prespecified for evaluation in relation to the Week 8 MIC-C clinical outcome.

Fractal-based Gait Training in Older Adults

The purpose of the study is to investigate the influence of walking with external visual cues on brain adaptations.

Cost-Effectiveness Analysis of the Healthy Beat Acupunch Regimen on Physical Fitness, Sleep Quality, and Quality of Life Among Community-Dwelling Older Adults

This study will evaluate the effects and preliminary cost-effectiveness of the Healthy Beat Acupunch (HBA) exercise program among community-dwelling older adults in Thailand. HBA is a 40-minute exercise program that combines gentle body movements with rhythmic tapping along traditional Chinese medicine meridian points. Older adults in the intervention group will participate in HBA exercise three times per week for 6 months. During months 1-3, the sessions will be led by trained exercise leaders. During months 4-6, participants will exercise using a prerecorded HBA video, with personnel present to monitor safety. Participants in the control group will continue their usual daily activities and usual health services without receiving the HBA program during the study period. Physical fitness, sleep quality, and health-related quality of life will be assessed at baseline, 3 months, and 6 months. The study will also compare the direct and indirect costs of the leader-led and video-led phases and conduct a preliminary cost-effectiveness analysis to examine whether the HBA program may be a practical and sustainable health-promotion approach for older adults living in the community.

Vicia Faba Peptides and Resistance Training in the Elderly

This randomized, double-blind, placebo-controlled clinical trial aims to investigate the effects of supplementation with peptides derived from Vicia faba L. combined with supervised resistance training in physically active and inactive older adults. Approximately 100 adults aged 60 years or older will be enrolled. Participants will first be classified as physically active or inactive according to their habitual physical activity level and will then be randomly assigned to receive either Vicia faba L.-derived peptides (2.5 g/day) or placebo. All participants will complete the same supervised resistance training program three times per week for four weeks and will receive nutritional monitoring. Assessments will be performed before and after the intervention to investigate changes in muscle strength and power, body composition, functional mobility, postural balance, physical function, frailty, mental health, quality of life, and cognitive performance. The study will also examine whether habitual physical activity level influences the responses to the combined supplementation and resistance training intervention.

Immersive Group Dance in Virtual Reality and Perceived Social Cohesion in Older Adults

This is a two-arm, parallel-group randomized controlled trial designed to evaluate the effects of an immersive virtual reality (VR)-based group dance program on perceived social cohesion among community-dwelling older adults, compared with a dose-matched conventional light physical activity program. A total of 180 eligible participants (men and women) will be randomized (1:1) to either the VR group dance condition or the control condition. Both interventions are delivered three times per week for five weeks (15 sessions total). The primary outcome is perceived social cohesion, measured using the Perceived Cohesion Scale (PCS) at baseline, post-intervention (week 5), and 30-day follow-up. Sex differences in response to the intervention will be examined as a secondary objective. This study has been approved by the Institutional Ethics Committee of Capital University of Physical Education and Sports (Approval No. IEC/CUPES/345KJB).

Effect of Pentadecanoic Acid Supplementation on Red Blood Cell Health and Biological Aging in Healthy Older Adults

This Phase II randomized, double-blind, placebo-controlled, parallel-group study will evaluate the effects of pentadecanoic acid (C15:0) supplementation on red blood cell (RBC) health and predicted biological age in healthy adults aged 55 years and older. A total of 93 participants will be randomized to receive 200 mg of C15:0, 300 mg of C15:0, or placebo daily for approximately 12 weeks. The primary objective is to assess the effect of C15:0 on red blood cell distribution width (RDW-CV), a marker of RBC health, compared with placebo. Secondary outcomes include measures of inflammation, hematologic and iron metabolism markers, circulating C15:0 levels, biological age-related biomarkers, sleep quality, fatigue, energy, and health-related quality of life. Safety and tolerability will also be evaluated throughout the study.

Disease Modifying Potential of 5mg of Melatonin on Cognition and Brain Health in Aging

The study will examine whether 5mg melatonin (over the counter, OTC) over a 9-month period improves Alzheimer's disease (AD) biomarkers and cognitive function in two groups of individuals: those with mild cognitive impairment (MCI+) and those who are not (MCI-). AD biomarkers will be measured from cerebrospinal fluid (CSF) obtained from lumbar punctures. Cognitive function will be evaluated with routine neuropsychological tests. AS OF AUGUST 2024, THE LUMBAR PUNCTURE PROCEDURES FOR THIS CLINICAL TRIAL HAVE BEEN ELIMINATED. THAT IS, PARTICIPANTS ARE NO LONGER RECEIVING A LUMBER PUNCTURE. BUT ARE CONTINUING TO RECEIVE TWO SEPARATE BLOOD DRAWS FOR BIOMARKER TESTING.

Effectiveness of a Smartphone Chatbot to Improve Exercise Adherence in Older Adults

This randomized controlled trial aims to evaluate the effectiveness of a smartphone-based chatbot in improving adherence to a 12-week home-based multicomponent exercise program in community-dwelling older adults. Participants will be randomly assigned to receive either a chatbot-supported exercise program delivered through Telegram or an equivalent paper-based exercise program. Both groups will perform the same exercise program, including strength, balance, flexibility, and walking exercises. The primary outcome is exercise adherence. Secondary outcomes include physical function, physical activity, participant satisfaction, usability of the chatbot, and adverse events. The study seeks to determine whether chatbot-based support can enhance adherence and improve health outcomes in older adults.

Protein-Distinct Macronutrient-Equivalent Diet 2

The central hypothesis is that the addition of minimally processed lean pork to a healthy plant-forward low ultra-processed diet will enhance nutrient adequacy, promote muscular fitness, and maintain metabolic functions for improved healthspan. A well-designed, randomized, controlled, crossover, feeding study with clinical and molecular mechanistic endpoints is proposed to provide the most definitive level of evidence logistically possible in humans and to establish the role of minimally processed lean pork in healthspan promotion. Utilizing an all-food-provided (dine-in and take-out) design over 18 weeks (rolling recruitment, 8+8, 2w washout), a comprehensive assessment of metabolomics, system biology, physical, and physiological markers that indicate the risk of age-related comorbidities-critical micronutrient deficiency, frailty, metabolic dysfunctions, and cognitive decline, is proposed in upper Midwesterners 65 years and older. A minimally processed plant-forward diet with or without added pork will be compared for over 250 outcome measures using mixed-effects modeling adjusting for covariates in R. n=15/diet/arm i.e., a total starting sample size of n=30 is proposed for 90% power.

The Effect of Reminiscence Therapy in Older Adults

This randomized controlled study examined the effects of reminiscence therapy on psychological well-being and mindfulness among community-dwelling older adults. A total of 90 participants were randomly assigned to an experimental group or a control group. The experimental group received a structured reminiscence therapy program, while the control group received no study intervention. Participants completed baseline assessments before the intervention and post-test assessments immediately after completion of the intervention. The study included 45 participants in the experimental group and 45 participants in the control group.

Generation Victoria Cohort 2020s: A Statewide Longitudinal Cohort Study of Victorian Children and Their Parents

Generation Victoria (GenV) is a longitudinal, population-based study of Victorian children and their parents that will bring together data on a wide range of conditions ,exposures and outcomes. GenV blends study-collected, study-enhanced and linked data. It will be multi-purpose, supporting observational, interventional, health services and policy research within the same cohort. It is designed to address physical, mental and social issues experienced during childhood, as well as the antecedents of a wide range of diseases of ageing. It seeks to generate translatable evidence (prediction, prevention, treatments, services) to improve future wellbeing and reduce the future disease burden of children and adults. The GenV Cohort 2020s is open to all children born over a two-year period, and their parents, residing in the state of Victoria Australia. The GenV Cohort 2020s is preceded by an Advance Cohort of children born between 5 Dec 2020 and 3 October 2021, and their parents. This comprises all families recruited at GenV's Vanguard hospital (Joan Kirner Women's and Children's) and at birthing hospitals throughout Victoria as GenV scaled up to commence recruiting for the GenV Cohort 2020s. The Advance Cohort have ongoing and full participation in GenV for their lifetime unless they withdraw but may have less complete data and biosamples.

A Study on the Effects of Forest Therapy on Sarcopenia

Purpose: The goal of this study is to investigate the effects of an 8-week Forest Based Intervention program on muscle strength, physical performance, and psychological well-being in older women with sarcopenia. Duration: The program lasts for 8 weeks, with 2 sessions per week (16 sessions total). Each session is approximately 180 minutes. Activities: Participants will take part in a structured program at the Caoling Shibi Forest Healing Base in Yunlin. The program includes forest trail walking, resistance training using elastic bands, stretching, and sensory activities such as aromatherapy and deep breathing. Assessments: Researchers will evaluate physical indicators and psychological well-being before the program, immediately after, and at a 1-month follow-up. Goal: We hope to determine if combining structured exercise with the forest environment can effectively improve the health and quality of life for older women with sarcopenia.

Land vs. Water Exercises on Performance and Swimming Behavior in Older Adults

This study aims to investigate the effects of an 8-week combined land and aquatic exercise program (conducted 3 days per week) on physical performance, recreational swimming behaviors, and water-related risk perceptions in older adults. Physical performance is evaluated using handgrip strength and the 30-second chair sit-up test (30CST), while swimming behaviors and water-related risk perceptions are assessed via structured questionnaires.

Sandplay-Act. Older: Structured Sandplay Activity for Older Individuals

This research was planned to determine the effect of structured sandplay activities on positive and negative affect and levels of meaning in life in elderly individuals. The research will be conducted as a single-blind, randomized controlled trial with a pre-test, post-test design at the Gül Kokulu Çınarlar Vefa Konağı of the Isparta Municipality Health Affairs Directorate between July 2026 and July 2027. Prior to the research, ethical committee approval and institutional permission for implementation will be obtained. The research population consists of 400 individuals registered with the institution. The sample will consist of 60 individuals (30 in the intervention group and 30 in the control group) who meet the inclusion criteria, are selected using block randomization, and provide informed consent. The control group will receive no intervention; a pre-test will be administered on the first day, and a post-test will be administered on the day the intervention for the experimental group ends. The intervention group will participate in sandplay activities twice a week for a total of four sessions; a pre-test will be administered on the first day, and a post-test will be administered in the last session. Data collection is planned for the period between July 2026 and July 2027 using the Personal Information Form (PIF), the Positive-Negative Affect Scale (PANAS), and the Meaning in Life Scale (MLS). Data will be analyzed using the SPSS (Statistical Program for Social Sciences) statistical analysis package, and statistical significance will be accepted at p \< 0.05.

Effects of Freeze-dried Grape Powder on Immune Profiles in Healthy Aging Adults

The purpose of this study is to investigate the effects of consuming grape powder on immune profiles in healthy middle- and older-aged individuals. Specifically, the investigators are interested in evaluating the potential effects of grapes in influencing markers of immune function, inflammation, and metabolism that are known to change with aging. Grapes contain several nutrients and antioxidant polyphenols such as resveratrol, quercetin, vitamin K and fiber, which are known to promote heart and immune health. However, the effects of grapes on altering immune profiles within the context of aging is not well understood. Therefore, this study will explore how daily grape consumption impacts certain markers of immunity in healthy middle- and older-aged adults. The main study procedures include consumption of a freeze-dried grape powder and control powder (which tastes the same but has none of the grape compounds that are being studied) mixed with water as a beverage on a daily basis for 4 weeks each. The investigators will additionally ask that participants avoid eating grapes and certain other antioxidant/grape-related foods and beverages throughout the 13-week study. Participants will additionally be asked to complete surveys about their diet, physical activity, and medical history, as well as provide blood samples and body weight measures throughout the course of the study. Participation in the study is expected to last about 6.25 hours over the course of 13 weeks and will include 7 visits.

Cardiorespiratory Fitness and Acute High-Intensity Exercise Effects on Brain and Cognitive Function in Older Adults

The goal of this clinical trial is to learn whether a single session of high-intensity interval exercise (HIIT) affects cognitive performance and brain activity in older adults, and whether cardiorespiratory fitness influences these effects. The main questions it aims to answer are: * Does a single HIIT session change performance on a task-switching test of cognitive flexibility? * Does a single HIIT session change prefrontal brain activity during cognitive testing, as measured by functional near-infrared spectroscopy (fNIRS)? * Do older adults with higher cardiorespiratory fitness show greater cognitive and brain changes in response to HIIT than those with lower fitness? Participants will: * Visit the laboratory on two separate days * Complete a sub-maximal graded exercise test during the first visit to measure cardiorespiratory fitness * Complete a single \~30-minute HIIT cycling session during the second visit * Complete a task-switching cognitive test before and after the HIIT session * Have their brain activity monitored with fNIRS while completing the cognitive tests

Adjuvant Nitrate to Boost Exercise-induced Health Benefits in Older Adults

Aging-related functional declines are thought to be caused by hallmark biological processes that ultimately manifest in physical, mental, and metabolic impairments to compromise intrinsic capacity and healthspan. Exercise is the only multipotent treatment with promise to mitigate many of the aging hallmarks, but there is substantial variability in individual exercise responsiveness. Thus, the investigators approach to boosting exercise responsiveness in aging is to combine an exercise training prescription containing both endurance and resistance training (in alignment with DHHS guidelines) with a nitrate-enriched dietary supplement to augment the cellular, tissue, and systemic adaptations that induce myriad health benefits of exercise in older adults.

What Makes People Better at Naming Pictured Objects

This study is being conducted to learn more about how mindful breathing might be related to the ability to produce names for pictured objects. Participants will engage with an exercise about mindful breathing or an auditory presentation and then name pictured objects as quickly as they can. They will also complete some surveys and other measures and wearing equipment on their finger to monitor their heart rate throughout the study. Participation will take approximately 1 hour.

Neuroathletic Exercise In The Elderly

Objective: The aim of this protocol study was to investigate the effect of neuroathletic exercise on walking speed, fall risk and cognitive function in the elderly. Method: The study is planned as a single-centre, double-blind, parallel group randomised controlled experimental design and will be conducted in accordance with SPIRIT. The sample of the study will consist of healthy elderly people aged 60-80 years. In order to ensure parametric conditions, the sample will be divided into two groups as experimental group (n=20) in which neuroathletic exercise will be performed and control group (n=20) in which Turkey Physical Activity Guidelines will be given and a total of 40 elderly people will be randomly assigned to the groups. The elderly assigned to the experimental and control groups according to the order of randomisation will be administered the timed up and go test (TUG), short physical performance battery (SPPB), geriatric depression scale (GDÖ), MoCA test as pre-test and post-test. The experimental group will be asked to perform neuroathletic exercises two days a week for 12 weeks under the supervision of a physiotherapist, and will be asked to perform a home exercise programme one day a week. The control group will be given the Turkish Physical Activity guide. Data will be collected by the researcher. Results: Considering the limited number of studies on the use of neuroathletic exercises in the literature, it is thought that our randomised controlled study designed to determine the effect of neuroathletic exercise on walking speed, fall risk and cognitive functions in the elderly will contribute to the literature.

cMIND AI Web Tool Usability Study (Hong Kong)

This study is testing a new web-based tool that uses artificial intelligence (AI) to help older adults in Hong Kong check how healthy their Cantonese-style meals are for brain health. The tool is based on the cMIND diet, a Chinese-adapted version of a known healthy eating pattern that may support memory and thinking skills. Participants will use the web app to take photos of their usual meals for at least 10 days over two weeks. The AI will automatically identify ingredients and give a score showing how well the meal follows the cMIND diet. The study will also ask participants to complete a short questionnaire and a brief interview to find out how easy and useful the tool is for older adults. The purpose of this small study is to see whether the AI tool is user-friendly and acceptable for older people. Results will help improve the tool for future use to support healthy ageing and brain health.

Improving Neurological Health in Aging Via Neuroplasticity-based Computerized Exercise

This study is a validation study to evaluate efficacy of a neuroplasticity-based, computerized cognitive training program INHANCE (Improving Neurological Health in Aging via Neuroplasticity-based Computerized Exercise) to improve neurological and neuropsychological health in older adults.

Reactive Balance Training for Fall Prevention

The objective of this pilot study is to evaluate and compare the effect of three different perturbation based training devices on the reactive balance control among healthy young adults, healthy older adults, and neurologically impaired stroke individuals. Furthermore, the project aims to determine the feasibility and tolerability of 30-minutes of perturbation training using the SureFooted Trainer. Overall, the project directs to find out the long term effect of training on fall risk reduction and fall prevention. This study investigates the effects of perturbation training (slip and trip) based on the principles of motor learning. Perturbations in the form of slips and trips induced by the three different types of perturbation devices will displace the center of mass outside the base of support and challenge the stability, thereby inducing a fall and demand compensatory strategies in order to prevent it. Such perturbation training would train the motor system to improve stability control and vertical limb support. The project design aims to examine the ability of the central nervous system to mitigate the interference in stability control (if any) that is induced by opposing types of perturbations. The hypothesis of this study if supported by the results, will provide the difference in motor learning with training on three different perturbation devices. Furthermore, it would help to determine which of the three training devices is the most effective in developing defense mechanisms necessary to reduce fall-risk among community-living older adults and the neurological population.

Evaluation of AppleX™ Apple Extract on Anti-Inflammatory and Healthy Aging Effects

The goal of this clinical trial is to learn if AppleX™ Apple Extract can help lower systemic inflammation in adults aged 45-70 with signs of low-grade inflammation. It will also look at the extract's effects on fatigue, joint comfort, and biological aging metrics. The main questions it aims to answer are: * Does taking AppleX™ Apple Extract daily lower high-sensitivity C-reactive protein (hsCRP) levels, a key marker of inflammation in the blood? * Does AppleX™ Apple Extract improve participant-reported fatigue and joint comfort? * Does the extract slow down biological or epigenetic aging metrics compared to a placebo? Researchers will compare AppleX™ Apple Extract to a placebo (a look-alike capsule that contains no active ingredients) to see if the apple extract has a measurable anti-inflammatory and healthy aging effect.

Effects of Miricell Supplementation on Biomarkers of Healthy Aging and Autophagy

The goal of this clinical trial is to learn if a dietary supplement called Miricell works to improve cellular health and signs of healthy aging in adults. It will also learn about the safety of Miricell. The main questions it aims to answer are: * Does Miricell improve markers of autophagy, which is the body's natural process for recycling damaged cells? * Does Miricell support brain health, metabolic health, and visible signs of aging? * What medical problems, if any, do participants experience while taking Miricell? Researchers will compare Miricell to a placebo (a look-alike capsule that contains no active ingredients) to see if Miricell works better to support healthy aging. Participants will: * Take either one Miricell capsule or a placebo every day for 12 weeks with a morning meal. * Visit the research clinic four times over the course of the study for checkups and tests. * Complete memory and thinking tests, track their daily physical activity, and give blood samples to measure health changes.