Effects of Daily Taurine Intake for 6 Months on Biological Age and Body Metabolism Indicators As Well As Physical Fitness in 55-75-year-old Women and Men

Launched by TECHNICAL UNIVERSITY OF MUNICH · Sep 22, 2024

Nctid: NCT06613542

Payload: {"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M10293", "name"=>"Inflammation", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"T19", "name"=>"Taurine", "asFound"=>"Every 30 minutes", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Amino Acids", "abbrev"=>"AA"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"QUADRUPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>80}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-09-25", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2026-03-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-22", "studyFirstSubmitDate"=>"2024-09-17", "studyFirstSubmitQcDate"=>"2024-09-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-03-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Change From Baseline in Biological Age At 6 Months (Proteome Analysis)", "timeFrame"=>"pre-intervention (at time point 0) and post-intervention (at 24 weeks)", "description"=>"The primary objective of the study is to answer the following research question:\n\nDoes a 6-month supplementation with 4g of taurine daily slow down biological aging in humans?\n\nBiological age will be determined using a plasma proteome analysis and established machine learning models based on plasma and urine samples. This will also include an analysis of organ-specific aging."}, {"measure"=>"Change From Baseline in Biological Age At 6 Months (DNA Methylation)", "timeFrame"=>"pre-intervention (at time point 0) and post-intervention (at 24 weeks)", "description"=>"The primary objective of the study is to answer the following research question:\n\nDoes a 6-month supplementation with 4g of taurine daily slow down biological aging in humans?\n\nBiological age will be estimated by assessing DNA methylation patterns (epigenetic clock) from plasma, urine, and oral mucosa samples."}], "secondaryOutcomes"=>[{"measure"=>"Change From Baseline In Cognitive Functions at 6 Months", "timeFrame"=>"pre-intervention (at time point 0) and post-intervention (after 24 weeks)", "description"=>"Does a 6-month supplementation with 4 g of taurine daily influence parameters of mental health?\n\nMethods of measurement: MoCA (Montreal Cognitive Assessment)"}, {"measure"=>"Change From Baseline In Cardiometabolic Risk Profile at 6 Months", "timeFrame"=>"pre-intervention (at time point 0) and post-intervention (at 24 weeks)", "description"=>"Does a 6-month supplementation with 4 g of taurine daily alter the cardiometabolic risk profile?\n\nMeasurement: fasting blood glucose in mg/dL"}, {"measure"=>"Change From Baseline In Cardiometabolic Risk Profile at 6 Months", "timeFrame"=>"pre-intervention (at time point 0) and post-intervention (at 24 weeks)", "description"=>"Does a 6-month supplementation with 4 g of taurine daily alter the cardiometabolic risk profile?\n\nMeasurement: Body-Mass-Index determined by participants weight in kilograms divided by height in metres squared."}, {"measure"=>"Change From Baseline In Cardiometabolic Risk Profile at 6 Months", "timeFrame"=>"pre-intervention (at time point 0) and post-intervention (at 24 weeks)", "description"=>"Does a 6-month supplementation with 4 g of taurine daily alter the cardiometabolic risk profile?\n\nMeasurement: blood pressure in mmHg"}, {"measure"=>"Change From Baseline In Cardiometabolic Risk Profile at 6 Months", "timeFrame"=>"pre-intervention (at time point 0) and post-intervention (at 24 weeks)", "description"=>"Does a 6-month supplementation with 4 g of taurine daily alter the cardiometabolic risk profile?\n\nMeasurement: total cholesterol in mg/dl"}, {"measure"=>"Change From Baseline In Cardiometabolic Risk Profile at 6 Months", "timeFrame"=>"pre-intervention (at time point 0) and post-intervention (at 24 weeks)", "description"=>"Does a 6-month supplementation with 4 g of taurine daily alter the cardiometabolic risk profile?\n\nMeasurement: LDL-cholesterol in mg/dL"}, {"measure"=>"Change From Baseline In Cardiometabolic Risk Profile at 6 Months", "timeFrame"=>"pre-intervention (at time point 0) and post-intervention (at 24 weeks)", "description"=>"Does a 6-month supplementation with 4 g of taurine daily alter the cardiometabolic risk profile?\n\nMeasurement: HDL-cholesterol in mg/dL"}, {"measure"=>"Change From Baseline In Cardiometabolic Risk Profile at 6 Months", "timeFrame"=>"pre-intervention (at time point 0) and post-intervention (at 24 weeks)", "description"=>"Does a 6-month supplementation with 4 g of taurine daily alter the cardiometabolic risk profile?\n\nMeasurement: C-reactive protein in mg/l"}, {"measure"=>"Change From Baseline In Cardiometabolic Risk Profile at 6 Months", "timeFrame"=>"pre-intervention (at time point 0) and post-intervention (at 24 weeks)", "description"=>"Does a 6-month supplementation with 4 g of taurine daily alter the cardiometabolic risk profile?\n\nMeasurement: fasting insulin in pmol/l"}, {"measure"=>"Change From Baseline In Handgrip Strength (kg) at 6 Months", "timeFrame"=>"pre-intervention (at time point 0) and post-intervention (at 24 weeks)", "description"=>"Measurement of handgrip strength in kilograms and Newtons in the dominant hand using Jamar Hydraulic Hand Dynamometer."}, {"measure"=>"Change From Baseline In Physical Working Capacity (PWC130) At 6 Months", "timeFrame"=>"pre-intervention (at time point 0) and post-intervention (at 24 weeks)", "description"=>"Measurement of heart rate (bpm) on the Corvial ergometer while increasing power manually by 25 W every 2 minutes. The endpoint is the power in Watts at the stage where heart rate of 130bpm is reached."}, {"measure"=>"Change From Baseline In Isometric Leg Extensor Strength For Each Leg At 6 Months", "timeFrame"=>"pre-intervention (at time point 0) and post-intervention (at 24 weeks)", "description"=>"Measurement of leg extensor strength using a force transducer connected to the back of a chair and an ankle loop, as well as force recording software. The maximum force (N) will be multiplied with the distance from knee joint to the middle of the loop (in metres) to calculate the torque in Newton-metres (Nm) for each leg."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["taurine", "biological aging", "metabolic health", "anti-aging", "epigenetic clock", "aging", "physical activity", "cognition", "Cellular Senescence", "hallmarks of aging", "humans", "Dietary Supplements", "longevity", "Taurine Deficiency", "Taurine Level", "aging metabolism", "longevity physiology", "drug effects", "DNA-methylation", "aging ptoeomics", "DNA methylation", "taurine microbiome", "taurine gut micorbiota", "taurine cognition", "taurine sport", "taurine DNA methylation", "nutritional medicine", "sport biology", "taurine physical fitness", "taurine physical acitvity", "taurine sport biology", "taurine muscle strength", "taurine pwc 130", "Taurine HOMA IR", "taurine mental health", "taurine human aging", "taurine cardiometabolic risk", "taurine cardiometabolic health", "taurine blood pressure", "taurine fasting glucose", "taurine inflammation", "taurine biological aging"], "conditions"=>["Taurine", "Aging, Biological", "Physical Activity", "Metabolic Health", "Anti-Aging", "Longevity", "Dietary Supplement", "DNA Methylation", "Sport"]}, "referencesModule"=>{"references"=>[{"pmid"=>"38057571", "type"=>"BACKGROUND", "citation"=>"Oh HS, Rutledge J, Nachun D, Palovics R, Abiose O, Moran-Losada P, Channappa D, Urey DY, Kim K, Sung YJ, Wang L, Timsina J, Western D, Liu M, Kohlfeld P, Budde J, Wilson EN, Guen Y, Maurer TM, Haney M, Yang AC, He Z, Greicius MD, Andreasson KI, Sathyan S, Weiss EF, Milman S, Barzilai N, Cruchaga C, Wagner AD, Mormino E, Lehallier B, Henderson VW, Longo FM, Montgomery SB, Wyss-Coray T. Organ aging signatures in the plasma proteome track health and disease. Nature. 2023 Dec;624(7990):164-172. doi: 10.1038/s41586-023-06802-1. Epub 2023 Dec 6."}, {"pmid"=>"37289866", "type"=>"BACKGROUND", "citation"=>"Singh P, Gollapalli K, Mangiola S, Schranner D, Yusuf MA, Chamoli M, Shi SL, Lopes Bastos B, Nair T, Riermeier A, Vayndorf EM, Wu JZ, Nilakhe A, Nguyen CQ, Muir M, Kiflezghi MG, Foulger A, Junker A, Devine J, Sharan K, Chinta SJ, Rajput S, Rane A, Baumert P, Schonfelder M, Iavarone F, di Lorenzo G, Kumari S, Gupta A, Sarkar R, Khyriem C, Chawla AS, Sharma A, Sarper N, Chattopadhyay N, Biswal BK, Settembre C, Nagarajan P, Targoff KL, Picard M, Gupta S, Velagapudi V, Papenfuss AT, Kaya A, Ferreira MG, Kennedy BK, Andersen JK, Lithgow GJ, Ali AM, Mukhopadhyay A, Palotie A, Kastenmuller G, Kaeberlein M, Wackerhage H, Pal B, Yadav VK. Taurine deficiency as a driver of aging. Science. 2023 Jun 9;380(6649):eabn9257. doi: 10.1126/science.abn9257. Epub 2023 Jun 9."}]}, "descriptionModule"=>{"briefSummary"=>"The goal of this clinical trial is to investigate the effect of taking 4 grams of taurine by older adults on aging processes over a period of 6 months. It will also check for effects of taurine on participant's physical fitness, metabolic and cognitive functions. The main question it aims to answer is:\n\n• Does a supplementation with 4 g of taurine daily over a period of 6 months slow down biological aging in humans? Researchers will compare supplementation with taurine to a placebo (a look-alike substance that contains no drug) to reliably determine whether taurine has an effect.\n\nParticipants will:\n\n* Take 4g of taurine or a placebo every day for 6 months\n* Visit the study site 4 times for checkups and tests: for a screening visit, at the beginning of the intervention, after 8 and 24 weeks", "detailedDescription"=>"Measurements performed during study visits:\n\n* Biological age estimate via proteome analysis\n* Organ age estimates (proteomics)\n* DNA methylation\n* Inflammatory biomarkers (CRP, cytokines)\n* Metabolic variables: fasting blood glucose, insulin, HOMA-IR, HbA1c, lipids, BMI\n* Physical fitness (hand grip strength, leg extensor strength, PWC130)\n* Resting energy expenditure\n* Cognitive function via questionnaire\n* Quality of life\n* Heart rate variability\n* Physical activity, nutrition"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"75 years", "minimumAge"=>"55 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* women or men\n* Age 55 - 75\n* BMI 22 - 30 kg/m²\n* written consent\n\nExclusion Criteria:\n\n* Acute or chronic inflammation (e.g. flu infection)\n* Severe chronic illness (e.g., Type 1 or Type 2 diabetes mellitus, COPD, renal insufficiency)\n* Myocardial infarction or stroke in the previous 6 months\n* Psychiatric disorder, including depression or dementia\n* Weight change of ≥ 5 kg in the last 6 months"}, "identificationModule"=>{"nctId"=>"NCT06613542", "acronym"=>"TauAge", "briefTitle"=>"Effects of Daily Taurine Intake for 6 Months on Biological Age and Body Metabolism Indicators As Well As Physical Fitness in 55-75-year-old Women and Men", "organization"=>{"class"=>"OTHER", "fullName"=>"Technical University of Munich"}, "officialTitle"=>"Effect of Daily Taurine Supplementation for 6 Months on Biological Age and Metabolic Biomarkers As Well As Physical Fitness in 55-75-year-old Women and Men: a Randomized Controlled Intervention Study", "orgStudyIdInfo"=>{"id"=>"2024-253-S-CB"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"4g of taurine daily", "description"=>"Intervention group (4g of taurine/day):\n\n2g of taurine (4 capsules, 500mg each) in the morning and 2g of taurine (4 capsules, 500mg each) in the evening for 6 months", "interventionNames"=>["Dietary Supplement: 4g of taurine daily"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Placebo", "interventionNames"=>["Dietary Supplement: Placebo"]}], "interventions"=>[{"name"=>"4g of taurine daily", "type"=>"DIETARY_SUPPLEMENT", "description"=>"Intervention group (4g of taurine/day): 2g of taurine (4 capsules, 500mg each) in the morning and 2g of taurine (4 capsules, 500mg each) in the evening for 6 months", "armGroupLabels"=>["4g of taurine daily"]}, {"name"=>"Placebo", "type"=>"DIETARY_SUPPLEMENT", "description"=>"Controll group (4g of placebo/day): 2g of placebo (4 capsules, 500mg each) in the morning and 2g of placebo (4 capsules, 500mg each) in the evening for 6 months", "armGroupLabels"=>["Placebo"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"80992", "city"=>"Munich", "country"=>"Germany", "contacts"=>[{"name"=>"Hans Hauner, Prof. Dr. med.", "role"=>"CONTACT", "email"=>"hans.hauner@tum.de", "phone"=>"+49 89 28924911"}, {"name"=>"Henning Wackerhage, Prof. Dr.", "role"=>"CONTACT", "email"=>"henning.wackerhage@tum.de", "phone"=>"+49 89 28924480"}, {"name"=>"Loubna Al Sadat, Dr. rer.nat", "role"=>"CONTACT"}, {"name"=>"Karolina A. Starzynska", "role"=>"CONTACT"}, {"name"=>"Martin Schönfelder, Dr. rer. nat.", "role"=>"CONTACT"}, {"name"=>"Hans Hauner, Prof. Dr. med.", "role"=>"CONTACT"}, {"name"=>"Henning Wackerhage, Prof. Dr.", "role"=>"CONTACT"}], "facility"=>"Institute for Nutritional Medicine of Technical University of Munich", "geoPoint"=>{"lat"=>48.13743, "lon"=>11.57549}}], "centralContacts"=>[{"name"=>"Hans Hauner, Prof. Dr. med.", "role"=>"CONTACT", "email"=>"hans.hauner@tum.de", "phone"=>"+49 89 28924911"}, {"name"=>"Henning Wackerhage, Prof. Dr.", "role"=>"CONTACT", "email"=>"henning.wackerhage@tum.de", "phone"=>"+49 89 28924480"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO", "description"=>"IPD will not be shared because of data privacy and confidentiality."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Technical University of Munich", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Stanford University", "class"=>"OTHER"}, {"name"=>"Rutgers University", "class"=>"OTHER"}, {"name"=>"Universitaet Innsbruck", "class"=>"OTHER"}, {"name"=>"LMU Klinikum", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Prof. Dr. med. Hans Hauner", "investigatorFullName"=>"Karolina Alicja Starzynska", "investigatorAffiliation"=>"Technical University of Munich"}}}}