VITAL-Age Trial (iVS-1 Investigation for Targeting Aging and Longevity)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Biological Aging Biomarkers
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effects of Bifidobacterium adolescentis (iVS-1) supplementation on biological aging markers, metabolic health, and functional health outcomes in midlife adults. The study explores whether modulation of aging-related biological pathways through the gut microbiome may influence health-related outcomes.
详细描述
Aging is associated with progressive physiological changes involving inflammation, cellular senescence, mitochondrial function, and alterations in the gut microbiome. Interventions targeting these biological processes may influence age-related health outcomes. The gut microbiome plays a central and modifiable role, influencing metabolic health, inflammation, neurocognitive outcomes, and systemic aging processes.
Reductions in Bifidobacterium adolescentis have been observed with aging and have been associated with metabolic and inflammatory changes. Preliminary studies suggest that supplementation with this species may affect biological pathways relevant to aging.
This study is a randomized, double-blind, placebo-controlled trial designed to evaluate the effects of Bifidobacterium adolescentis (iVS-1) supplementation in adults aged 40-75 years. Participants will be randomized to receive iVS-1 (≥8 billion CFU per capsule) or placebo once daily for 150 days. Blood- and stool-based assessments and questionnaires about cognition, sleep quality, and quality of life will be collected at baseline, mid-intervention, and end of study.
Changes in these measures will be used to assess the relationship between Bifidobacterium adolescentis iVS-1 supplementation and biological aging markers, metabolic health, and functional health outcomes.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 40-75 years.
- •BMI: 20-34.9 kg/m².
- •Able and willing to sign informed consent and participate for the study duration.
排除标准
- •Chronic disease history (liver, kidney, heart).
- •Current pregnancy and/or lactating.
- •Colonoscopy and/or its preparation within 4 weeks of screening.
- •Those who intend to have children during study period.
- •Current probiotic, prebiotics and/or metabolic-altering supplement use.
- •Those who are unable to cooperate with investigators and testing.
- •Known history of cancer and/or ongoing cancer treatments.
- •Abuse of drugs, alcohol, tobacco, nicotine and other substances.
- •History of cardiac diseases: atherosclerosis, heart failure, unstable angina, stable angina, etc., and chronic hypoxic disease: emphysema, pulmonary heart disease and others related.
- •History of chronic and major GI disease (pancreatitis, IBS, and IBD) and intestinal surgeries.
- •Type 1 or 2 diabetes mellitus.
- •Poorly controlled chronic diseases (hypertension, hyperlipidemia) that are clinically unstable.
- •Vulnerable groups, including clinically ill, mentally ill, cognitively impaired, minors, and illiterate etc.
- •Significant weight loss (>20%) in prior one month.
- •Conditions affecting safety or outcome integrity.
研究组 & 干预措施
Placebo
Placebo capsule
干预措施: Placebo (Dietary Supplement)
Bifidobacterium adolescentis iVS-1
Probiotic Capsule
干预措施: Bifidobacterium adolescentis iVS-1 (Dietary Supplement)
结局指标
主要结局
Change in Biological Aging Biomarkers
时间窗: Baseline to Day 150
Changes in gene expression of biomarkers associated with biological aging, assessed by quantitative polymerase chain reaction (qPCR), compared between placebo and study product groups over the study duration, including stratified analyses based on Bifidobacterium abundance.
次要结局
- Change in Phenotypic Age(Baseline to Day 150)
- Change in Bifidobacterium adolescentis iVS-1 Abundance(Baseline to Day 150)
- Change in Metabolic Health(Baseline to Day 150)
- Change in Lipid Profiles(Baseline to Day 150)
- Change in Cognitive Function(Baseline to Day 150)
- Change in Sleep Quality(Baseline to Day 150)
- Change in Quality of Life(Baseline to Day 150)