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

Not Applicable

Recruiting

• Conditions: Taurine; Aging, Biological; Physical Activity; Metabolic Health; Anti-Aging; Longevity; Dietary Supplement; DNA Methylation; Sport
• Interventions: Dietary Supplement: 4g of taurine daily; Dietary Supplement: Placebo

• Registration Number: NCT06613542
• Lead Sponsor: Technical University of Munich

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

Study Timeline

• Study First Submitted: 2024-09-17
• Study First Submitted QC: 2024-09-22
• Study Start: 2024-09-25
• Study First Posted: 2024-09-26
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-22
• Primary Completion: 2026-03-30
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4g of taurine daily	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
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Biological Age At 6 Months (Proteome Analysis)	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.
Change From Baseline in Biological Age At 6 Months (DNA Methylation)	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline In Cognitive Functions at 6 Months	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)
Change From Baseline In Cardiometabolic Risk Profile at 6 Months	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
Change From Baseline In Handgrip Strength (kg) at 6 Months	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.
Change From Baseline In Physical Working Capacity (PWC130) At 6 Months	pre-intervention (at time point 0) and post-intervention (at 24 weeks)	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.
Change From Baseline In Isometric Leg Extensor Strength For Each Leg At 6 Months	pre-intervention (at time point 0) and post-intervention (at 24 weeks)	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.

Trial Locations

Locations (1)

Institute for Nutritional Medicine of Technical University of Munich; 🇩🇪 Munich, Germany