iVS-1 probiotic to target biological aging in midlife adults
VITAL-Age Trial (iVS-1 Investigation for Targeting Aging and Longevity)
This trial will test whether taking a daily iVS-1 (Bifidobacterium adolescentis) probiotic for 150 days can change biological aging markers and improve metabolic, cognitive, sleep, and quality-of-life measures in adults aged 40–75.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Synbiotic Health Industry-sponsored |
| Locations | 1 site (New Port Richey, Florida) |
| Trial ID | NCT07407894 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled trial will enroll adults 40–75 years old to receive either iVS-1 (Bifidobacterium adolescentis, ≥8 billion CFU per capsule) or placebo once daily for 150 days. Blood and stool samples plus questionnaires on cognition, sleep, and quality of life will be collected at baseline, mid-intervention, and end of study to measure biological aging markers, metabolic health, inflammation, and gut microbiome changes. The study tests whether modulating the gut microbiome with iVS-1 can alter aging-related pathways such as inflammation, cellular senescence, and mitochondrial function. Participants with major chronic diseases, diabetes, recent colonoscopy, current probiotic use, pregnancy, or a history of significant GI or cardiac disease are excluded.
Who should consider this trial
Good fit: Ideal candidates are generally healthy adults aged 40–75 with BMI 20–34.9 kg/m² who can attend in-person visits and are willing to avoid other probiotics or metabolic supplements during the 150-day intervention.
Not a fit: People with major chronic illnesses (heart, liver, kidney), diabetes, active cancer, major gastrointestinal disease or surgery, recent colonoscopy, pregnancy, or current probiotic use are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, iVS-1 supplementation could slow or reverse markers of biological aging and improve metabolic, cognitive, sleep, and quality-of-life outcomes in midlife adults.
How similar studies have performed: Preclinical and small observational studies note age-related declines in Bifidobacterium adolescentis and suggest potential metabolic and inflammatory benefits from supplementation, but randomized clinical evidence in midlife humans is limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New Port Richey, Florida
- MusB Research LLC — New Port Richey, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Shalini Jain, PhD
- Email: jains@musbresearch.com
- Phone: 813-419-0781
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.