- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06613542
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 (TauAge)
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
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:
• 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.
Participants will:
- Take 4g of taurine or a placebo every day for 6 months
- 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Measurements performed during study visits:
- Biological age estimate via proteome analysis
- Organ age estimates (proteomics)
- DNA methylation
- Inflammatory biomarkers (CRP, cytokines)
- Metabolic variables: fasting blood glucose, insulin, HOMA-IR, HbA1c, lipids, BMI
- Physical fitness (hand grip strength, leg extensor strength, PWC130)
- Resting energy expenditure
- Cognitive function via questionnaire
- Quality of life
- Heart rate variability
- Physical activity, nutrition
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Munich, Germany, 80992
- Institute for Nutritional Medicine of Technical University of Munich
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- women or men
- Age 55 - 75
- BMI 22 - 30 kg/m²
- written consent
Exclusion Criteria:
- Acute or chronic inflammation (e.g. flu infection)
- Severe chronic illness (e.g., Type 1 or Type 2 diabetes mellitus, COPD, renal insufficiency)
- Myocardial infarction or stroke in the previous 6 months
- Psychiatric disorder, including depression or dementia
- Weight change of ≥ 5 kg in the last 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
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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
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|
Active Comparator: 4g of taurine daily
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 |
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline in Biological Age At 6 Months (Proteome Analysis)
Time Frame: pre-intervention (at time point 0) and post-intervention (at 24 weeks)
|
The primary objective of the study is to answer the following research question: Does a 6-month supplementation with 4g of taurine daily slow down biological aging in humans? Biological 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. |
pre-intervention (at time point 0) and post-intervention (at 24 weeks)
|
|
Change From Baseline in Biological Age At 6 Months (DNA Methylation)
Time Frame: pre-intervention (at time point 0) and post-intervention (at 24 weeks)
|
The primary objective of the study is to answer the following research question: Does a 6-month supplementation with 4g of taurine daily slow down biological aging in humans? Biological age will be estimated by assessing DNA methylation patterns (epigenetic clock) from plasma, urine, and oral mucosa samples. |
pre-intervention (at time point 0) and post-intervention (at 24 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline In Cognitive Functions at 6 Months
Time Frame: pre-intervention (at time point 0) and post-intervention (after 24 weeks)
|
Does a 6-month supplementation with 4 g of taurine daily influence parameters of mental health? Methods of measurement: MoCA (Montreal Cognitive Assessment) |
pre-intervention (at time point 0) and post-intervention (after 24 weeks)
|
|
Change From Baseline In Cardiometabolic Risk Profile at 6 Months
Time Frame: pre-intervention (at time point 0) and post-intervention (at 24 weeks)
|
Does a 6-month supplementation with 4 g of taurine daily alter the cardiometabolic risk profile? Measurement: fasting blood glucose in mg/dL |
pre-intervention (at time point 0) and post-intervention (at 24 weeks)
|
|
Change From Baseline In Cardiometabolic Risk Profile at 6 Months
Time Frame: pre-intervention (at time point 0) and post-intervention (at 24 weeks)
|
Does a 6-month supplementation with 4 g of taurine daily alter the cardiometabolic risk profile? Measurement: Body-Mass-Index determined by participants weight in kilograms divided by height in metres squared. |
pre-intervention (at time point 0) and post-intervention (at 24 weeks)
|
|
Change From Baseline In Cardiometabolic Risk Profile at 6 Months
Time Frame: pre-intervention (at time point 0) and post-intervention (at 24 weeks)
|
Does a 6-month supplementation with 4 g of taurine daily alter the cardiometabolic risk profile? Measurement: blood pressure in mmHg |
pre-intervention (at time point 0) and post-intervention (at 24 weeks)
|
|
Change From Baseline In Cardiometabolic Risk Profile at 6 Months
Time Frame: pre-intervention (at time point 0) and post-intervention (at 24 weeks)
|
Does a 6-month supplementation with 4 g of taurine daily alter the cardiometabolic risk profile? Measurement: total cholesterol in mg/dl |
pre-intervention (at time point 0) and post-intervention (at 24 weeks)
|
|
Change From Baseline In Cardiometabolic Risk Profile at 6 Months
Time Frame: pre-intervention (at time point 0) and post-intervention (at 24 weeks)
|
Does a 6-month supplementation with 4 g of taurine daily alter the cardiometabolic risk profile? Measurement: LDL-cholesterol in mg/dL |
pre-intervention (at time point 0) and post-intervention (at 24 weeks)
|
|
Change From Baseline In Cardiometabolic Risk Profile at 6 Months
Time Frame: pre-intervention (at time point 0) and post-intervention (at 24 weeks)
|
Does a 6-month supplementation with 4 g of taurine daily alter the cardiometabolic risk profile? Measurement: HDL-cholesterol in mg/dL |
pre-intervention (at time point 0) and post-intervention (at 24 weeks)
|
|
Change From Baseline In Cardiometabolic Risk Profile at 6 Months
Time Frame: pre-intervention (at time point 0) and post-intervention (at 24 weeks)
|
Does a 6-month supplementation with 4 g of taurine daily alter the cardiometabolic risk profile? Measurement: C-reactive protein in mg/l |
pre-intervention (at time point 0) and post-intervention (at 24 weeks)
|
|
Change From Baseline In Cardiometabolic Risk Profile at 6 Months
Time Frame: pre-intervention (at time point 0) and post-intervention (at 24 weeks)
|
Does a 6-month supplementation with 4 g of taurine daily alter the cardiometabolic risk profile? Measurement: fasting insulin in pmol/l |
pre-intervention (at time point 0) and post-intervention (at 24 weeks)
|
|
Change From Baseline In Handgrip Strength (kg) at 6 Months
Time Frame: pre-intervention (at time point 0) and post-intervention (at 24 weeks)
|
Measurement of handgrip strength in kilograms and Newtons in the dominant hand using Jamar Hydraulic Hand Dynamometer.
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pre-intervention (at time point 0) and post-intervention (at 24 weeks)
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Change From Baseline In Physical Working Capacity (PWC130) At 6 Months
Time Frame: pre-intervention (at time point 0) and post-intervention (at 24 weeks)
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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.
|
pre-intervention (at time point 0) and post-intervention (at 24 weeks)
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Change From Baseline In Isometric Leg Extensor Strength For Each Leg At 6 Months
Time Frame: pre-intervention (at time point 0) and post-intervention (at 24 weeks)
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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.
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pre-intervention (at time point 0) and post-intervention (at 24 weeks)
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- physical activity
- cognition
- aging
- DNA methylation
- Dietary Supplements
- humans
- drug effects
- anti-aging
- taurine
- longevity
- metabolic health
- biological aging
- DNA-methylation
- Cellular Senescence
- epigenetic clock
- hallmarks of aging
- Taurine Deficiency
- Taurine Level
- aging metabolism
- longevity physiology
- aging ptoeomics
- 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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-253-S-CB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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