Collagen Peptides and Cellular Aging: a Randomized, Placebo-controlled Intervention Study on Telomere Length, Inflammation, Body Composition, and Functional Capacity in Middle-aged and Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Telomere length
研究概览
简要总结
The goal of this clinical trial is to learn if daily collagen peptide supplementation can stabilize or lengthen telomeres and improve related markers of cellular aging in adults aged 50-70 years with overweight and low-to-moderate physical activity (healthy volunteers without major chronic disease).
Main questions it aims to answer are:
Does six months of collagen peptides stabilize or extend telomere length and increase telomerase activity compared with placebo? Are any telomere-related changes associated with lower inflammation, healthier body composition, and better functional health?
Researchers will compare collagen as an intervention to a placebo group to see if collagen will influence aging markers.
Participants will take collagen peptides or a placebo daily for 24 weeks. They will attend three study visits: one before starting the intervention (T0), one at 3 months (T1), and one at 6 months (T2). At each visit, blood samples will be collected to measure telomere length, telomerase activity, and inflammation/redox markers. Participants will also undergo body composition assessments using bioelectrical impedance, complete functional tests of muscle strength and mobility, and fill out questionnaires on health and vitality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 50-70 years; both male and female participants are eligible
- •Body mass index (BMI) 25-30 kg/m²
- •Low to moderate physical activity: not meeting current WHO recommendations (<150 minutes/week) or ≤2 sessions/week structured training
- •Able to live independently and mobile in daily life
- •No regular resistance training within the past 6 months
- •Provision of written informed consent
排除标准
- •Diagnosed chronic diseases relevant to the immune system, metabolism, or cellular aging (e.g., diabetes mellitus, cancer, cardiovascular, rheumatologic diseases)
- •Use of immunomodulatory, systemic anti-inflammatory, or hormonal medications (e.g., corticosteroids, immunosuppressants)
- •Acute infections or surgeries within the last 3 months
- •Regular use of supplements known to affect oxidative stress or cellular aging (e.g., high-dose antioxidants, CoQ10, omega-3 fatty acids, high-dose vitamin D)
- •Participation in another clinical study within the last 3 months
- •Vegetarian or vegan diet (product contains animal-derived collagen)
研究组 & 干预措施
Collagen Peptides
Participants receive daily oral supplementation with specific collagen peptides for 24 weeks. Allocation is randomized 1:1 and double-blinded against placebo. Study visits occur at baseline (T0), 3 months (T1), and 6 months (T2). Blood samples are collected to assess telomere length (qPCR T/S ratio) and telomerase activity (TRAP), alongside inflammation and redox markers. Body composition (bioelectrical impedance), functional tests (muscle strength, mobility), and questionnaires on health and vitality are also performed. The intervention aims to test whether six months of collagen peptides stabilize or extend telomeres and increase telomerase activity compared with placebo.
干预措施: Collagen peptides (Dietary Supplement)
Maltodextrin
Participants receive a daily placebo matched in a double-blind design for 24 weeks, with the same schedule of study visits at T0, T1, and T2 and the same assessments (blood biomarkers of telomere biology, inflammation/redox; body composition; functional tests; questionnaires) as the verum arm. Maltodextrin serves as the control to compare effects against collagen peptides in a randomized, double-blind, placebo-controlled, parallel-group trial.
干预措施: Maltodextrin (Placebo) (Dietary Supplement)
结局指标
主要结局
Telomere length
时间窗: Baseline and after supplementation (24 weeks)
Changes in leukocyte telomere length (qPCR) from peripheral blood
Telomerase Activity
时间窗: Baseline and at the end of supplemention (24 weeks)
Changes telomerase activity measured via TRAP Assay from peripheral blood
Change from baseline in DNA-oxidation markers
时间窗: Baseline and at the end of supplementation (24 weeks)
Change in DNA Damage measured through comet assay
Change from baseline in micronuclei
时间窗: Baseline and at the end of supplementation (24 weeks)
Change in Micronulei measured through CBMN-Assay
次要结局
- Change from baseline in Inflammatory markers(Baseline and at the end of supplemention (24 weeks))
- Change from baseline in the redox/antioxidant status(Baseline and at the end of supplementation (24 weeks))
- Change from baseline in body composition(Basline, after 3 months and at the end of the supplementation (24 weeks))
- Change from baseline metabolic markers(Baseline and at the end of supplementation (24 weeks))
- Change from baseline in hormonal markers(Baseline and at the end of supplementation (24 weeks))
- Change from baseline in muscle strength(Baseline, after 3 months and at the end of supplementation (24 weeks))
- Change from baseline in dietary intake(Baseline, after 3 months and at the end of supplementation (24 weeks))
- Change from baseline in patient-reported outcomes like quality of life(Baseline, after 3 months and at the end of supplementation (24 weeks))
- Change of phase angle(Basline, after 3 months and at the end of the supplementation (24 weeks))
- Change from baseline in Insulin(Baseline and at the end of supplementation (24 weeks))
- Change from baseline in patient-reported outcomes like sleep quality(Baseline, after 3 months and at the end of supplementation (24 weeks))
- Change from baseline in patient-reported outcomes like health(Baseline, after 3 months and at the end of supplementation (24 weeks))
- Change from baseline in patient-reported outcomes like fatigue(Baseline, after 3 months and at the end of supplementation (24 weeks))
- Change from baseline in oxidative stress(Baseline and at the end of supplementation (24 weeks))
研究者
Daniel König
Univ. Professor Dr.
University of Vienna