iVS-1 Probiotic Intervention Targeting Biological Aging in Midlife Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bifidobacterium adolescentis iVS-1, Placebo.
- Who it may be relevant to
- Registry conditions: Healthy Aging, Anti Aging. Basic parameters: 40 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
VITAL-Age Trial (iVS-1 Investigation for Targeting Aging and Longevity)
Overview
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.
Detailed description
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.
Interventions
- Dietary supplement Bifidobacterium adolescentis iVS-1
B. adolescentis iVS-1 (probiotic capsule) delivered orally once daily at a minimum of 8 billion CFU/day - Dietary supplement Placebo
Placebo capsule delivered orally once daily
Primary outcome measures
- Change in Biological Aging Biomarkers [Time frame: Baseline to Day 150]
Secondary outcome measures (7)
- Change in Phenotypic Age [Time frame: Baseline to Day 150]
- Change in Bifidobacterium adolescentis iVS-1 Abundance [Time frame: Baseline to Day 150]
- Change in Metabolic Health [Time frame: Baseline to Day 150]
- Change in Lipid Profiles [Time frame: Baseline to Day 150]
- Change in Cognitive Function [Time frame: Baseline to Day 150]
- Change in Sleep Quality [Time frame: Baseline to Day 150]
- Change in Quality of Life [Time frame: Baseline to Day 150]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- MusB Research LLC — New Port Richey
Identifiers
NCT: NCT07407894 · MB-VITAL