[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643280":3},{"organization":4,"outcomesModule":7,"designInfo":113,"detailedDescription":112,"studyPopulation":112,"armGroups":123,"interventions":136,"overallOfficials":112,"centralContacts":145,"locations":151,"responsibleParty":166,"collaborators":168,"id":175,"slug":112,"hasResults":176,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":112,"eligibilityCriteria":180,"healthyVolunteers":181,"sex":182,"minAge":183,"maxAge":184,"enrollmentInfo":185,"targetDuration":112,"studyType":188,"phases":189,"briefSummary":191,"conditions":192,"keywords":112,"overallStatus":153,"whyStopped":112,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":203},{"fullName":5,"class":6},"National University of Malaysia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":62,"otherOutcomes":112},[9,13,17,20,23,26,29,32,35,38,41,44,47,50,53,56,59],{"measure":10,"description":11,"timeFrame":12},"Blood pressure","Blood pressure in mmHg using Sphygmomanometer","Baseline, Month 3 and Month 6",{"measure":14,"description":15,"timeFrame":16},"Changes in Advanced Glycation End Products (AGEs)","Changes in blood AGEs concentration measured by ELISA will be quantified as circulating glycoxidation markers and expressed in arbitrary units (AU) or µg\u002FmL","Baseline, Month 3, and Month 6",{"measure":18,"description":19,"timeFrame":16},"Changes in Protein Carbonyl","Change in blood protein carbonyl concentration measured by ELISA , will be quantified as nmol carbonyl\u002Fmg protein",{"measure":21,"description":22,"timeFrame":16},"Change in Malondialdehyde (MDA)","Change in blood malondialdehyde concentration measured by high-performance liquid chromatography (HPLC)",{"measure":24,"description":25,"timeFrame":16},"Change in DNA Damage","Change in blood DNA damage levels measured using validated laboratory assays",{"measure":27,"description":28,"timeFrame":16},"Body Composition assessment","Measured using Inbody 770 Analyzer at Physiology Department; BMI (kg\u002Fm²) calculated from weight (kg) and height (m); Body fat percentage (%); visceral fate (cm²); basal metabolic rate (kcal); waist to hip ratio",{"measure":30,"description":31,"timeFrame":16},"Food intake questionnaire","Food frequency questionnaires (FFQ) will be completed by the participants, and analyse through Diet Information Management System; Result reported for carbohydrate (g), Cholesterol (mg), Energy (kcal), Fat (g), Fibre (g), Protein (g), vitamin E (mg), water (g)",{"measure":33,"description":34,"timeFrame":16},"Changes in SASP Gene expression","Change in senescence-associated secretory phenotype (SASP) gene expression levels in peripheral blood measured by quantitative real-time polymerase chain reaction (qRT-PCR)",{"measure":36,"description":37,"timeFrame":16},"Change in SASP Protein expression","Change in senescence-associated secretory phenotype (SASP) protein expression levels in peripheral blood measured using protein array analysis",{"measure":39,"description":40,"timeFrame":16},"Change in Tumor Necrosis Factor-Alpha (TNF-α)","Change in blood TNF-α concentration measured by enzyme-linked immunosorbent assay (ELISA), qill be quantified in picograms per millilitre (pg\u002FmL).",{"measure":42,"description":43,"timeFrame":16},"Change in Inteleukin-6 (IL-6)","Change in blood IL-6 concentration measured by enzyme-linked immunosorbent assay (ELISA)",{"measure":45,"description":46,"timeFrame":16},"Change in ATP production","Change in mitochondrial ATP production in peripheral blood measured using Seahorse analysis",{"measure":48,"description":49,"timeFrame":16},"Change in Mitochondrial Complex V Enzyme Activity","Change in mitochondrial Complex V enzyme activity measured in peripheral blood samples",{"measure":51,"description":52,"timeFrame":16},"Change in Mitochondrial Membrane Potential","Changes in mitochondrial membrane potential measured in peripheral blood samples",{"measure":54,"description":55,"timeFrame":16},"Change in Plasma Alpha-Tocotrienol Concentration","Change in plasma α-tocotrienol concentration measured by HPLC will be quantified in micromoles per litre (µmol\u002FL) or micrograms per millilitre (µg\u002FmL).",{"measure":57,"description":58,"timeFrame":16},"Change in Plasma Gamma- Tocotrienol Concentration","Change in plasma γ-tocotrienol concentration measured by HPLC will be quantified in micromoles per litre (µmol\u002FL) or micrograms per millilitre (µg\u002FmL).",{"measure":60,"description":61,"timeFrame":16},"Change in Total Plasma Tocotrienol Concentration","Change in total plasma tocotrienol concentration measured by HPLC will be quantified in micromoles per litre (µmol\u002FL) or micrograms per millilitre (µg\u002FmL).",[63,67,70,73,76,79,82,85,89,93,97,100,103,106,109],{"measure":64,"description":65,"timeFrame":66},"Muscle mass","Appendicular lean mass in kilograms, kg will be measured using Dual-Energy X-ray Absorptiometry, (DEXA)","Baseline and Month 6",{"measure":68,"description":69,"timeFrame":66},"Fat mass","Fat mass in gram, g will be measured using Dual-Energy X-ray Absorptiometry, (DEXA)",{"measure":71,"description":72,"timeFrame":66},"Bone mineral content (BMC)","Bone mineral content in gram, g will be measured using Dual-Energy X-ray Absorptiometry, (DEXA)",{"measure":74,"description":75,"timeFrame":66},"Cognitive Function","The assessment instrument, the Montreal Cognitive Assessment (MoCA) test will be administered. The evaluation involves assessing participants through questions and instructions covering executive and spatial cognitive domains. The maximum score is 30. A score of 26 and above indicates no cognitive impairment.",{"measure":77,"description":78,"timeFrame":66},"Recall memory function","The Rey Auditory Verbal Learning Test (RAVLT) will be utilized. the RAVLT includes two distinct word lists (A and B). Participants will recall the items from list A over five trials (Memory A1 to A5). Following this, an interference list (list B), comprising 15 unrelated nouns, will be introduced, and participants will attempt to recall as many words as possible from it. Subsequently, participants will be asked to recall the words from list A (Delayed recall\u002Fmemory A6) without the examiner repeating the list. The number of correctly recalled words for each trial will be totaled to generate a score.\n\nTotal Learning Score (Sum of Trials A1-A5) to indicate normal performance: 45-65, Mild Cognitive impairment: 30-45, dementia: below 30. For delayed recall score (M6), to indicate normal performance: ≥8-12 words recalled, Mild Cognitive Impairment: 4-7 words recalled, and dementia: ≤3 words recalled",{"measure":80,"description":81,"timeFrame":66},"Working memory function","The Digit Span Test involves recalling numbers in the same order (forward), reverse order (backward), or ascending order (sequencing). The test starts with short sequences and increases in length to assess memory capacity. A higher score (20 - 30) indicates better cognitive function, while a lower score (0 - 19) may suggest attention or memory issues. The total score is 30.",{"measure":83,"description":84,"timeFrame":66},"Change in Pulse Wave Velocity (PWV)","Change in arterial stiffness assessed by pulse wave velocity using an Arteriograph device, will be recorded in metres per second (m\u002Fs)",{"measure":86,"description":87,"timeFrame":88},"Change in Augmentation Index (Aix)","Change in arterial wave reflection assessed by augmentation index using an Arteriograph device will be expressed as a percentage (%).","Baseline, and Month 6",{"measure":90,"description":91,"timeFrame":92},"Change in Central Blood Pressue","Change in central blood pressure measured using an Arteriograph device will be measured in millimetres of mercury (mmHg)","Baseline, and month 6",{"measure":94,"description":95,"timeFrame":96},"Change in Skin Elasticity","Change in skin elasticity measured using a Cutometer, quantify in Arbitary unit","Baseline and month 6",{"measure":98,"description":99,"timeFrame":96},"Change in Skin Hydration","Change in skin hydration measured using a Corneometer, quantify in Arbitary unit",{"measure":101,"description":102,"timeFrame":66},"Change in Transepidermal Water Loss","Change in skin barrier function measured as transepidermal water loss using a Tewameter quantify in Arbitary unit",{"measure":104,"description":105,"timeFrame":66},"Change in Skin Pigmentation","Change in skin pigmentation measured using a mexameter quantify in Arbitary unit",{"measure":107,"description":108,"timeFrame":66},"Change in sebum secretion","Change in skin sebum secretion measured using a Sebumeter quantify in Arbitary unit",{"measure":110,"description":111,"timeFrame":66},"Change in Skin Wrinkle and Roughness","Change in wrinkle and skin roughness parameters measured using a visiocan quantify in Arbitary unit",null,{"allocation":114,"interventionModel":115,"interventionModelDescription":112,"primaryPurpose":116,"observationalModel":112,"timePerspective":112,"maskingInfo":117},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":118,"maskingDescription":112,"whoMasked":119},"TRIPLE",[120,121,122],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[124,130],{"label":125,"type":126,"description":127,"interventionNames":128},"Investigational product (IP)","EXPERIMENTAL","Participant receiving investigational product at 200mg daily",[129],"Dietary Supplement: Treatment",{"label":131,"type":132,"description":133,"interventionNames":134},"Placebo","PLACEBO_COMPARATOR","Participant receiving placebo capsules at 200mg daily",[135],"Other: Placebo",[137,142],{"type":138,"name":139,"description":140,"armGroupLabels":141,"otherNames":112},"DIETARY_SUPPLEMENT","Treatment","Each participant will receive 200mg\u002Fday of tocotrienol-rich fraction capsules divided into two daily doses",[125],{"type":6,"name":131,"description":143,"armGroupLabels":144,"otherNames":112},"Participant will receive placebo softgel of 200mg divided into two daily doses",[131],[146],{"name":147,"role":148,"phone":149,"phoneExt":112,"email":150},"Suzana Makpol","CONTACT","603-91459554","suzanamakpol@ukm.edu.my",[152],{"facility":5,"status":153,"city":154,"state":154,"zip":155,"country":156,"countryCode":157,"cosmosGeoPoint":158,"geoPoint":163,"contacts":164},"RECRUITING","Kuala Lumpur","56000","Malaysia","MY",{"type":159,"coordinates":160},"Point",[161,162],101.68653,3.1412,{"lat":162,"lon":161},[165],{"name":147,"role":148,"phone":149,"phoneExt":112,"email":150},{"type":167,"investigatorFullName":112,"investigatorTitle":112,"investigatorAffiliation":112,"oldNameTitle":112,"oldOrganization":112},"SPONSOR",[169,172],{"name":170,"class":171},"Malaysia Palm Oil Board","OTHER_GOV",{"name":173,"class":174},"Davos Life Science Pte Ltd","INDUSTRY","100643280",false,"NCT07637487","Tocotrienol Supplementa as A Senolytic Agent in Middle-aged Adults","A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial Evaluating Tocotrienol-Rich Fraction as a Senolytic Agent in Middle-Aged Adults","Inclusion Criteria:\n\n* Generally healthy as assessed by physical examination and blood lab test, including adequate liver and renal function, Neutrophil count \\> 1500\u002Fmm3, Platelet count 120,000 - 450,000\u002Fmm3, Haemoglobin concentration 11.5 to 19.0g\u002FdL for men; 10.5-17.5 g\u002FdL for women, Prothrombin and partial thromboplastin time within normal range, ALT and AST \\\u003C 80 IU\u002FL, Creatinine 0.7 to 1.3 mg\u002FdL\n* Subject of either gender, 35 to 64 years of age (inclusive)\n* Not allergy to palm oil and vitamin E\n* Do not take vitamin E supplements over the past 3 months\n* Provide written informed consent prior to screening\n* Subject is willing and able to comply with the study visit schedule and procedure, geographic proximity (investigator's discretion) that allows adequate follow up\n* Subjects understand the study protocol and signed informed consent forms\n\nExclusion Criteria:\n\n* Subjects with fat malabsorption\n* Subjects with chronic conditions such as cardiac diseases (heart failure, myocardial infraction, ischemic heart disease), neurological diseases, diabetes, HIV infection, psychiatric illness\u002Fsocial situations\n* Subjects with vegan diet\n* Current smoker or used to smoke in the past 3 months\n* Subject for surgery or had undergone surgery in the past 3 months\n* Current or past history of drug, alcohol abuse and cancer\n* Pregnant and lactating women\n* History of bleeding tendencies or any condition predisposing to bleeding e.g. thrombocytopenia, abnormal liver function, liver disease (e.g. chronic hepatitis), gastrointestinal ulcers\n* Any subject taking antibiotics or other medication or dietary supplement which could interfere with the action of tocotrienols\n* Subjects who are pre-disposed to inherited blood\u002Fcirculation disorders\n* Subject who is taking anticoagulants and antithrombotic drugs, e.g. warfarin, aspirin, ticlopidine, heparin, etc.",true,"ALL","35 Years","50 Years",{"count":186,"type":187},220,"ESTIMATED","INTERVENTIONAL",[190],"NA","The goal of this clinical trial is to determine whether tocotrienol works as a senolytic agent to delay age-related biological changes in middle-aged adults. The study will also evaluate the safety of tocotrienol supplementation. The main questions it aims to answer are:\n\nDoes tocotrienol reduce markers of cellular senescence, inflammation, oxidative stress, and mitochondrial dysfunction?\n\nWhat health changes or medical issues occur in participants taking tocotrienol?\n\nResearchers will compare tocotrienol-rich fraction to a placebo (a look-alike capsule with no active ingredient) to determine whether tocotrienol is effective in modulating aging-related pathways.\n\nParticipants will:\n\nTake tocotrienol (200 mg\u002Fday) or a placebo daily for 6 months\n\nAttend study visits at baseline, 3 months, and 6 months for clinical assessments and laboratory tests\n\nUndergo blood sampling and health evaluations, including measures of senescence-associated secretory phenotype (SASP), inflammation, oxidative stress, mitochondrial function, vascular health, skin status, cognitive function, body composition, and bone mineral density.\n\nComplete questionnaires related to diet throughout the study period\n\nThis study aims to provide clinical evidence on the potential of tocotrienol as a senolytic intervention for promoting healthy aging and reducing the risk of age-related diseases.",[193],"Healthy","2026-06-04",{"date":196,"type":197},"2026-06-09","ACTUAL",{"date":199,"type":197},"2023-10-31",{"date":201,"type":187},"2027-01-30",{"name":5,"class":6},1]