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
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Taurine
Aging, Biological
Physical Activity
Metabolic Health
Anti-Aging
Longevity
Dietary Supplement
DNA Methylation
Sport
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
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Stanford University
name: Rutgers University
name: Universitaet Innsbruck
name: LMU Klinikum
First posted: 2024-09-26
Enrollment: 80
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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

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

Eligibility criteria: 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

Primary outcomes:
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)
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)
Secondary outcomes:
measure: Change From Baseline In Cognitive Functions at 6 Months
timeFrame: pre-intervention (at time point 0) and post-intervention (after 24 weeks)
measure: Change From Baseline In Cardiometabolic Risk Profile at 6 Months
timeFrame: pre-intervention (at time point 0) and post-intervention (at 24 weeks)
measure: Change From Baseline In Cardiometabolic Risk Profile at 6 Months
timeFrame: pre-intervention (at time point 0) and post-intervention (at 24 weeks)
measure: Change From Baseline In Cardiometabolic Risk Profile at 6 Months
timeFrame: pre-intervention (at time point 0) and post-intervention (at 24 weeks)
measure: Change From Baseline In Cardiometabolic Risk Profile at 6 Months
timeFrame: pre-intervention (at time point 0) and post-intervention (at 24 weeks)
measure: Change From Baseline In Cardiometabolic Risk Profile at 6 Months
timeFrame: pre-intervention (at time point 0) and post-intervention (at 24 weeks)
measure: Change From Baseline In Cardiometabolic Risk Profile at 6 Months
timeFrame: pre-intervention (at time point 0) and post-intervention (at 24 weeks)
measure: Change From Baseline In Cardiometabolic Risk Profile at 6 Months
timeFrame: pre-intervention (at time point 0) and post-intervention (at 24 weeks)
measure: Change From Baseline In Cardiometabolic Risk Profile at 6 Months
timeFrame: pre-intervention (at time point 0) and post-intervention (at 24 weeks)
measure: Change From Baseline In Handgrip Strength (kg) at 6 Months
timeFrame: pre-intervention (at time point 0) and post-intervention (at 24 weeks)
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)
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)
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Institute for Nutritional Medicine of Technical University of Munich
Study officials:
References:
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.
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.