[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pre-frailty\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pre-frailty":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,53,92,121],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100639066","phase-2-tcm-formula-vs-hmb-in-pre-frail-elders-muscle-strength-and-bone-status-100639066",false,"NCT07597850","TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status","Effects of Traditional Chinese Medicine (TCM) Formula vs. HMB on Muscle Strength and Bone Status in Pre-Frail Elders: A Comparative Study","TCM-HMB-PF","Inclusion Criteria:\n\n* Male or female participants aged 65 years or older at the time of screening.\n* Body Mass Index less than 30 kilograms per square meter.\n* Identified as pre-frail according to the Fried frailty phenotype, meeting 1 to 2 of the following 5 criteria: 1) Hand grip strength below specific thresholds based on gender and Body Mass Index. For males, Body Mass Index 24 or less is 29 kilograms or less, Body Mass Index 24.1 to 28 is 30 kilograms or less, Body Mass Index greater than 28 is 32 kilograms or less. For females, Body Mass Index 23 or less is 17 kilograms or less, Body Mass Index 23.1 to 26 is 17.3 kilograms or less, Body Mass Index 26.1 to 29 is 18 kilograms or less, Body Mass Index greater than 29 is 21 kilograms or less. 2) Slow walking speed. For a 4-meter distance, walking time of 7 seconds or more for males 173 centimeters or shorter, or 6 seconds or more for males taller than 173 centimeters. For females 159 centimeters or shorter, 7 seconds or more, or 6 seconds or more for females taller than 159 centimeters. 3) Self-reported exhaustion. Answering 3 days or more per week to either feeling that everything was an effort or could not get going in the past week. 4) Unintentional weight loss. Loss of 3 kilograms or more or more than 5 percent of body weight in the past year. 5) Low physical activity. Weekly energy expenditure less than 383 kilocalories for males or less than 270 kilocalories for females.\n* Ability to safely complete a 6-meter walk test in a single attempt without assistance or using only simple aids such as a cane.\n* Clinically stable condition allowing for follow-up visits every 4 weeks and participation in all study-related assessments.\n* Willingness to provide existing test data from within 90 days prior to randomization, including Bone Mineral Density by DXA and serum biochemistry or urinalysis results.\n* Sufficient cognitive function to understand the study and sign the informed consent form, or with the assistance of a legal representative.\n* Willingness to maintain existing diet and exercise habits during the study and not start high-intensity exercise programs or large amounts of nutritional supplements.\n\nExclusion Criteria:\n\n* Major acute illness such as acute myocardial infarction, pneumonia, or acute stroke within 2 weeks prior to screening.\n* Major organ dysfunction, including renal function with estimated glomerular filtration rate less than 45 milliliters per minute per 1.73 square meters within 1 month prior to screening, liver function with AST or ALT greater than 3 times the upper limit of normal within 1 month prior to screening, NYHA Class III or IV heart failure, or severe COPD requiring long-term oxygen therapy.\n* Unplanned hospitalization within 1 month prior to screening, or major surgery with incomplete functional recovery within 3 months prior to screening.\n* Current malignant tumor under treatment, or less than 12 months since the completion of cancer treatment.\n* Use of supplements containing the same ingredients as the study interventions, or products that may affect the primary endpoint including HMB, creatine, branched-chain amino acids, or high-dose protein powder within 4 weeks prior to screening.\n* Known significant clinical allergy or hypersensitivity to any components of the study formula or HMB nutritional supplement.\n* Moderate to severe dementia, severe depression, or other psychiatric disorders resulting in inability to cooperate without a legal representative.\n* Participation in other interventional clinical trials involving drugs, biologics, or nutritional supplements within 3 months prior to screening.\n* New initiation or dose adjustment of medications affecting muscle or bone metabolism within 3 months prior to screening, including systemic glucocorticoids, anabolic steroids, testosterone, or growth hormones.\n* Any other condition that, in the opinion of the investigator, makes the participant unsuitable for the study due to safety or compliance concerns.","ALL","65 Years",{"count":20,"type":21},90,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this study is to compare the effects of a standardized Traditional Chinese Medicine (TCM) formula versus beta-hydroxy-beta-methylbutyrate (HMB) on muscle strength and bone health in pre-frail older adults . Pre-frailty is a critical stage where functional decline may still be reversed through proper intervention. The study will enroll 90 participants aged 65 years or older who meet the criteria for pre-frailty. Participants will be randomly assigned to either the TCM group (receiving a standardized herbal powder formula) or the HMB group (receiving nutritional supplement tablets) for 24 weeks . The primary objective is to evaluate the change in handgrip strength from baseline to Week 12 . Researchers will also assess changes in skeletal muscle mass, bone mineral density, and overall physical performance . The goal is to determine if the TCM formula is an effective alternative or complementary intervention for managing geriatric frailty.",[27,28,29,30,31],"Pre-Frailty","Sarcopenia","Muscle Atrophy or Weakness","Osteoporosis","Aging",[33,34,35,36,37,38,39],"Traditional Chinese Medicine","HMB (Hydroxy-beta-methylbutyrate)","Muscle Strength","Handgrip Strength","Body Composition","Elderly Health","Randomized Controlled Trial","RECRUITING","2026-05-13",{"date":43,"type":44},"2026-05-19","ACTUAL",{"date":46,"type":44},"2026-04-02",{"date":48,"type":21},"2026-12-31",{"name":50,"class":51},"Tri-Service General Hospital","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":17,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100632896","frailty-improvement-through-technology-with-informal-caregiver-supported-exercise-fitwise-for-pre-frail-and-frail-community-dwelling-older-adults-100632896","NCT07519642","Frailty Improvement Through Technology With Informal Caregiver Supported Exercise (FITWISE) for Pre-frail and Frail Community-dwelling Older Adults","The Development and Feasibility Testing of a Caregiver-mediated, Technology-facilitated, Home-based Frail Intervention Program (FITWISE) for Pre-frail and Frail Community-dwelling Older Adults: a Three-arm Pilot Randomized Controlled Trial","FITWISE","1. For Participants:\n\n   Inclusion Criteria:\n   * Recruited from Lions Befrienders Active Aging Centres (AACs) or Tzu Chi Active Aging Centres (AACs)\n   * Aged 60 to 99 years\n   * Clinical Frailty Scale (CFS) score of 3 to 5\n   * Identified by the active aging centre as inactive in centre and community activities\n   * Able to provide valid informed consent\n   * Able to communicate in and read Chinese or English\n   * Living in their own homes and not in residential care\n   * Willing to allow home visits by the research team\n   * Residing in a home environment assessed as safe for exercise (e.g., adequate space and minimal environmental fall hazards)\n\n   Exclusion Criteria:\n   * Significant cognitive impairment or mental health conditions that prevent understanding of the study or safe participation in the exergaming activity (e.g., moderate to severe Alzheimer's disease)\n   * Pre-existing medical conditions that prohibit exercise or are hemodynamically unstable (e.g., end-stage heart failure)\n   * Physical limitations that hinder participation (e.g., wheelchair-bound)\n   * Severe visual or hearing impairments that would interfere with participation\n   * Experiencing severe pain that limits participation\n   * Currently participating in another regular vigorous exercise program\n   * Refusal to consent to video recording required for the exergaming system\n2. For Informal Caregiver\n\nInclusion Criteria:\n\n* Spouse, partner, child, relative, friend, or neighbor of the participant who provides unpaid support\n* Living with the participant or living separately\n* Aged 21 to 99 years\n* Able to communicate in and read English or Chinese\n* Living with the participant or willing to visit the participant two to three times per week to support the intervention\n* Cognitively fit as indicated by a Montreal Cognitive Assessment (MoCA) score above the normal cutoff\n* Assessed by the research team to be suitable for delivering the intervention\n\nExclusion Criteria:\n\n\\- Paid caregivers, such as healthcare professionals or foreign domestic helpers.",true,"21 Years","99 Years",{"count":65,"type":21},60,[67],"NA","The goal of this pilot trial is to evaluate the feasibility and potential effectiveness of a caregiver-mediated, technology-facilitated home-based intervention named Frailty Improvement through Technology With Informal Caregiver Supported Exercise (FITWISE) for pre-frail and frail community-dwelling older adults aged 60 years and older.\n\nFrailty is associated with reduced physical function, increased risk of falls, and higher healthcare utilization among older adults. Home-based interventions supported by informal caregivers and facilitated by digital technology may help improve exercise participation and health outcomes in this population.\n\nThe main questions this study aims to answer are:\n\n1. Whether the FITWISE intervention is feasible in terms of recruitment, participant engagement, adherence, retention, and safety.\n2. Whether the FITWISE intervention improves physical performance and other health-related outcomes among pre-frail and frail community-dwelling older adults.\n\nResearchers will compare two intervention groups with a control group to determine whether the FITWISE intervention improves health outcomes.\n\nParticipants will be randomly assigned to one of three groups:\n\n* Intervention Group A: Caregiver-mediated multi-component exercise supported by an exergaming system.\n* Intervention Group B: The same exercise program with additional caregiver-delivered psychosocial support.\n* Control Group: General health education and usual activities without the FITWISE intervention.\n\nThe intervention will last 24 weeks and will include an active 12-week intervention phase followed by a 12-week maintenance phase. Outcome measures such as physical performance, frailty status, cognitive function, social support, quality of life, and selected health indicators will be assessed at baseline and after the intervention.",[70,27],"Frailty",[70,72,73,74,75,76,77,78,79,80],"Pre-frailty","Older adults","Caregiver-mediated exercise interventions","Home-based exercise","Artificial intelligence","Exergame","Multicomponent exercise","Community-dwelling older adults","Digital health intervention","NOT_YET_RECRUITING","2026-04-06",{"date":84,"type":44},"2026-04-09",{"date":86,"type":21},"2027-02-01",{"date":88,"type":21},"2028-06-30",{"name":90,"class":51},"National University of Singapore",2,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":17,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":105,"conditions":106,"keywords":107,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":52},"100627898","exploratory-study-on-a-multi-nutrient-supplement-and-exercise-program-for-improving-health-markers-associated-to-longevity-in-pre-frail-adults-100627898","NCT07454616","Exploratory Study on a Multi-nutrient Supplement and Exercise Program for Improving Health Markers Associated to Longevity in Pre-frail Adults","A Single-arm Exploratory Study to Investigate the Feasibility to Develop a Composite Score That Encompasses Gut (Microbiome), Muscle, Immune, Cognition Outcomes Based on a 12-weeks Intervention of a Novel Multi-nutrient Supplement Containing Synbiotics, Combined With Supervised Exercise in Pre-frail Individuals Aged 50 - 80 Years Old.","RtM","Inclusion Criteria\n\n1. Singapore residents of all ethnic groups\n2. Adults aged 50-80 years (both male and female)\n3. Body mass index (BMI) ≥18 kg\u002Fm²\n4. Classified as Prefrailty according to Fried frailty criteria\n5. Willing and able to attend all data collection visits and to comply with the exercise and supplementation protocols.\n6. Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n1. Current use of supplements containing: Bifidobacterium longum 536 (BB536) like Kordel's BB536 bifidus; Bifidobacterium longum such as GniiB immunity; GOS (Galacto-oligosaccharides); FOS (Fructo-oligosaccharides); Inulin or any commercial healthy-aging powdered milk products\n2. BMI \\>30 kg\u002Fm2 3 Being on special diets including but not limited to ketogenic diets or diets prescribed by a healthcare professional\n\n4\\. Received any vaccination within the past 8 weeks. 5. Inition of new medication or use of medications affecting gastrointestinal function within the past 8 weeks, including but not limited to antibiotics or Proton pump inhibitors 6. Known allergies or intolerances, including, soy allergy; fibre allergy (e.g., GOS) or requirement for a fibre-free diet; fish allergy; Cow's milk protein allergy or lactose intolerance; galactosaemia 7. More than two unstable chronic conditions (e.g., hypertension, diabetes, hyperlipidemia, osteoarthritis, COPD) 8. Medical conditions for which probiotic use is contraindicated, including but not limited to immunocompromised individuals, astrointestinal failure or severe gastrointestinal disturbances (e.g., blood in stool), presence of a central venous catheter, open wounds following surgery 9. Contraindications to oral feeding, including gastrointestinal failure, complete intestinal obstruction, inability to access the gut or high loss intestinal fistulae 10. Known renal disease were unable to tolerate 2 servings per day. 11. Intake of supplemental calcium \\>500 mg\u002Fday or vitamin D \\>40 µg\u002Fday (1600 IU) from all sources, including diet and supplements 12. Use of medications that may interact with or impair absorption of milk products (e.g., tetracyclines) 13. Any other condition deemed by PI that may compromise participant safety and study compliance.","50 Years","80 Years",{"count":103,"type":21},40,[67],"Frailty is associated with biological changes in the gut microbiome and immune system, along with marked declines in physical and cognitive function, leading to an overall reduction in quality of life. Prefrailty represents an early stage where interventions may prevent or reverse these declines. This study aims to evaluate whether a 12-week combined Synbiotic enriched oral nutritional supplement and supervised exercise program can improve muscle strength and mass, gut microbiome composition, immune function, and cognitive performance in prefrail adults aged 50-80 years.",[27,31],[108,109,110,111,112],"Prefrail elderly","Gut microbiome","Nutritional supplementation","supervised exercise","Biological age markers","2026-03-03",{"date":115,"type":44},"2026-03-06",{"date":117,"type":44},"2025-09-22",{"date":119,"type":21},"2026-05-08",{"name":90,"class":51},{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":61,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":22,"phases":130,"briefSummary":131,"conditions":132,"keywords":137,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":52},"100589558","the-effect-of-pectin-supplementation-on-geriatric-with-frailty-a-randomised-placebo-controlled-dietary-intervention-study-100589558","NCT06955975","The Effect of Pectin Supplementation on Geriatric With Frailty: A Randomised Placebo-Controlled Dietary Intervention Study","GEOFF","Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study.\n* Participant eligibility includes those aged \\>65 years who have a body mass index (BMI) between 18.5 and 39.9 kg\u002Fm2.\n* Participants who are considered as pre-frail or frail based on FRAIL (Simple Frailty Questionnaire).\n\nExclusion Criteria:\n\n* Have gastrointestinal conditions e.g. malabsorptive conditions such as IBS\u002FIBD, coeliac or functional conditions such as gastroparesis or food intolerances etc.\n* History of major surgery which potentially limit participation or completion of the study.\n* History of gastrointestinal resection surgery, including bariatric surgery.\n* Used of antibiotics, antifungal medications, probiotics or prebiotics 90 days before the start of the study.\n* Are taking the following medications: immunosuppressants, amiodarone and\u002For perhexiline.\n* Are currently following or anticipated to commence a specialised commercially available weight loss diet and\u002For program.\n* History of side effects towards probiotics or prebiotics.\n* History or current psychiatric illness.\n* History or current neurological condition (e.g. epilepsy).\n* Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance.",{"count":129,"type":21},30,[67],"The study involves the intake of Low-methoxy (LM) pectin (polysaccharides extracted from citrus peels), which are commonly found in the UK diet (not pharmacological agents), to test their effects on systematic inflammation in the body and gut microbiome composition. Study subjects will be healthy elderly with early signs of frailty or pre-frailty from the local population and will be asked to attend the laboratory on 2 occasions; before and after 4-week' supplementing the diet daily with either 10g of pectin with 10g of whey protein and 10g of cocoa powder added as flavour (active arm) or 10g of whey protein with 10g of cocoa powder added as flavour (placebo). Participants will be given the blinded products portioned in individual sachets, with instructions to add the contents of one sachet a day to 150ml of milk and to consume immediately.\n\nAt each study visit (\\~90 minutes), participants will be asked to provide a stool and blood sample, will have blood pressure, heart rate, weight, height, and waist\u002Fhip ratio measured, research team will perform physical functioning test (Time up and go test, 30-second sit to stand test) as well as participants will complete the quality-of-life questionnaire (SF-36), the Depression and Anxiety (HADS) and the Gastrointestinal Symptom Rating Scale (GSRS).",[133,27,70,134,135,136],"Frailty at Older Adults","Diet","Dietary Fiber","Systemic Inflammatory Response",[138,139,70,27,140,141,109],"Pectin","LM Pectin","Systemic inflammation","Dietary intervention","2025-06-17",{"date":144,"type":44},"2025-06-22",{"date":146,"type":44},"2025-02-10",{"date":148,"type":21},"2026-03-31",{"name":150,"class":51},"University of Nottingham"]