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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change From Baseline in Biological Age At 6 Months (Proteome Analysis)
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •women or men
- •Age 55 - 75
- •BMI 22 - 30 kg/m²
- •written consent
排除标准
- •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
结局指标
主要结局
Change From Baseline in Biological Age At 6 Months (Proteome Analysis)
时间窗: 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)
时间窗: 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.
次要结局
- Change From Baseline In Cognitive Functions at 6 Months(pre-intervention (at time point 0) and post-intervention (after 24 weeks))
- Change From Baseline In Handgrip Strength (kg) at 6 Months(pre-intervention (at time point 0) and post-intervention (at 24 weeks))
- Change From Baseline In Physical Working Capacity (PWC130) At 6 Months(pre-intervention (at time point 0) and post-intervention (at 24 weeks))
- 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))
- Change From Baseline In Cardiometabolic Risk Profile at 6 Months(pre-intervention (at time point 0) and post-intervention (at 24 weeks))
研究者
Karolina Alicja Starzynska
Prof. Dr. med. Hans Hauner
Technical University of Munich