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Recruiting Not applicable

iVS-1 Probiotic Intervention Targeting Biological Aging in Midlife Adults

NCT07407894 · tracked via the Priya Life Science USA tracker
Sponsor
Synbiotic Health
Phase
Not applicable
Started
2026-02-01
Last updated
2026-04-22

Condition(s) studied

Healthy AgingAnti Aging

Investigational drug(s) / intervention(s)

Bifidobacterium adolescentis iVS-1Placebo

Bifidobacterium adolescentis iVS-1: B. adolescentis iVS-1 (probiotic capsule) delivered orally once daily at a minimum of 8 billion CFU/day

Placebo: Placebo capsule delivered orally once daily

Study summary

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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
75 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Change in Biological Aging Biomarkers — 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.

Trial sites (1)

FacilityCityRegionStatus
MusB Research LLC New Port Richey Florida Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07407894 on ClinicalTrials.gov ↗ ← All trials in the USA