iVS-1 Probiotic Intervention Targeting Biological Aging in Midlife Adults

VITAL-Age Trial (iVS-1 Investigation for Targeting Aging and Longevity)

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.

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.

Inclusion Criteria:

• Aged 40-75 years.
• BMI: 20-34.9 kg/m².
• Able and willing to sign informed consent and participate for the study duration.

Exclusion Criteria:

• 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.