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NCT Number: NCT07407894

iVS-1 Probiotic Intervention Targeting Biological Aging in Midlife Adults

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.

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Key information

Conditions

Healthy Aging Anti Aging

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MusB Research LLC

New Port Richey, Florida, 34638, United States

Location status: Recruiting

Location contact

Shalini Jain, PhD

CONTACT

[email protected]

813-419-0781

Shalini Jain, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bifidobacterium adolescentis iVS-1

Dietary Supplement

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

Placebo

Dietary Supplement

Placebo capsule delivered orally once daily

Primary outcomes

  1. Change in Biological Aging Biomarkers

    Time frame: 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.

Secondary outcomes

  1. Change in Phenotypic Age

    Time frame: Baseline to Day 150

    Changes in Phenotypic Age calculated as a single value from blood-based biomarkers (albumin, creatinine, glucose, C-reactive protein, lymphocyte count, mean cell volume, red cell distribution width, alkaline phosphatase, and white blood cell count) and chronological age compared between placebo and study product groups over the study duration, including stratified analyses based on Bifidobacterium abundance.

  2. Change in Bifidobacterium adolescentis iVS-1 Abundance

    Time frame: Baseline to Day 150

    Changes in fecal Bifidobacterium adolescentis iVS-1 abundance, 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.

  3. Change in Metabolic Health

    Time frame: Baseline to Day 150

    Changes in metabolic health biomarkers assessed by Comprehensive Metabolic Panel (CMP) compared between placebo and study product groups over the study duration, including stratified analyses based on Bifidobacterium abundance.

  4. Change in Lipid Profiles

    Time frame: Baseline to Day 150

    Changes in lipid profiles assed by a lipid panel compared between placebo and study product groups over the study duration, including stratified analyses based on Bifidobacterium abundance.

  5. Change in Cognitive Function

    Time frame: Baseline to Day 150

    Changes in global and executive cognitive function assessed using validated cognitive assessments compared across timepoints and between placebo and study product groups, including stratified analyses based on Bifidobacterium abundance.

  6. Change in Sleep Quality

    Time frame: Baseline to Day 150

    Changes in sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI) compared across timepoints and between placebo and study product groups, including stratified analyses based on Bifidobacterium abundance.

  7. Change in Quality of Life

    Time frame: Baseline to Day 150

    Changes in quality-of-life scores assessed using the Short Form-36 Health Survey (SF-36) compared across timepoints and between placebo and study product groups, including stratified analyses based on Bifidobacterium abundance.

Other outcomes

  1. Change in Gut Microbiota Composition

    Time frame: Baseline to Day 150

    Changes in gut microbiome composition and diversity assessed using metagenomic sequencing of fecal samples compared across timepoints and between placebo and study product groups, including stratified analyses based on Bifidobacterium abundance.

  2. Change in Gut Microbiota Function

    Time frame: Baseline to Day 150

    Changes in gut microbiome function assessed using metagenomic sequencing of fecal samples compared across timepoints and between placebo and study product groups, including stratified analyses based on Bifidobacterium abundance.

  3. Change in Fecal Metabolites

    Time frame: Baseline to Day 150

    Changes in fecal and plasma metabolites, including short-chain fatty acids (SCFAs), bile acids, and trimethylamine N-oxide (TMAO) compared across timepoints and between placebo and study product groups, including stratified analyses based on Bifidobacterium abundance.

  4. Change in Gut Permeability Markers

    Time frame: Baseline to Day 150

    Changes in gut permeability markers assessed using validated enzyme-linked immunosorbent assay (ELISA) techniques compared across timepoints and between placebo and study product groups, including stratified analyses based on Bifidobacterium abundance.

  5. Change in Inflammatory Markers

    Time frame: Baseline to Day 150

    Changes in inflammatory markers assessed using validated enzyme-linked immunosorbent assay (ELISA) techniques compared across timepoints and between placebo and study product groups, including stratified analyses based on Bifidobacterium abundance.

Study contacts

Contact information is provided by the study sponsor or research team.

Indushekar Manjunatha

CONTACT

[email protected]

Shalini Jain, PhD

CONTACT

[email protected]

813-419-0781

Sponsors and collaborators

Lead sponsor

Synbiotic Health

Industry

Collaborators

  • MusB Research

Registry information

Official study title

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

Acronym: VITAL

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 12, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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