iVS-1 Probiotic Intervention Targeting Biological Aging in Midlife Adults (VITAL)

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Aging; Anti Aging
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Bifidobacterium adolescentis iVS-1

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shalini Jain, PhD; Phone Number: 813-419-0781; Email: jains@musbresearch.com
• Study Contact Backup: Name: Indushekar Manjunatha; Email: imanjunatha@musbresearch.com

Study Locations

• United States
  • Florida
    • New Port Richey, Florida, United States, 34638
      • Recruiting
      • MusB Research LLC
      • Contact: Shalini Jain, PhD; Phone Number: 813-419-0781; Email: jains@musbresearch.com
      • Principal Investigator: Shalini Jain, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo capsule	Dietary supplement: Placebo; Placebo capsule delivered orally once daily
Experimental: Bifidobacterium adolescentis iVS-1; Probiotic Capsule	Dietary supplement: Bifidobacterium adolescentis iVS-1; B. adolescentis iVS-1 (probiotic capsule) delivered orally once daily at a minimum of 8 billion CFU/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Biological Aging Biomarkers	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.	Baseline to Day 150

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Phenotypic Age	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.	Baseline to Day 150
Change in Bifidobacterium adolescentis iVS-1 Abundance	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.	Baseline to Day 150
Change in Cognitive Function	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.	Baseline to Day 150
Change in Sleep Quality	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.	Baseline to Day 150
Change in Quality of Life	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.	Baseline to Day 150
Change in Metabolic Health	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.	Baseline to Day 150
Change in Lipid Profiles	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.	Baseline to Day 150

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gut Microbiota Composition	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.	Baseline to Day 150
Change in Gut Microbiota Function	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.	Baseline to Day 150
Change in Fecal Metabolites	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.	Baseline to Day 150
Change in Gut Permeability Markers	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.	Baseline to Day 150
Change in Inflammatory Markers	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.	Baseline to Day 150

Collaborators and Investigators

• Sponsor: Synbiotic Health
• Collaborators: MusB Research

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: January 28, 2026
• First Submitted That Met QC Criteria: February 5, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Aging; Probiotic; Gut Microbiome; Geroscience; Healthspan; Bifidobacterium adolescentis; iVS-1
• Other Study ID Numbers: MB-VITAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No