NCT07407894

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress29%
Feb 2026Jan 2027

First Submitted

Initial submission to the registry

January 28, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

January 28, 2026

Last Update Submit

April 21, 2026

Conditions

Healthy AgingAnti Aging

Keywords

Bifidobacterium adolescentisiVS-1AgingGeroscienceGut MicrobiomeProbioticHealthspan

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Change in Phenotypic Age

    Baseline to Day 150

  • Change in Bifidobacterium adolescentis iVS-1 Abundance

    Baseline to Day 150

  • Change in Metabolic Health

    Baseline to Day 150

  • Change in Lipid Profiles

    Baseline to Day 150

  • Change in Cognitive Function

    Baseline to Day 150

  • +2 more secondary outcomes

Other Outcomes (5)

  • Change in Gut Microbiota Composition

    Baseline to Day 150

  • Change in Gut Microbiota Function

    Baseline to Day 150

  • Change in Fecal Metabolites

    Baseline to Day 150

  • +2 more other outcomes

Study Arms (2)

Bifidobacterium adolescentis iVS-1

EXPERIMENTAL

Probiotic Capsule

Dietary Supplement: Bifidobacterium adolescentis iVS-1

Placebo

PLACEBO COMPARATOR

Placebo capsule

Dietary Supplement: Placebo

Interventions

Bifidobacterium adolescentis iVS-1DIETARY_SUPPLEMENT

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

Bifidobacterium adolescentis iVS-1
PlaceboDIETARY_SUPPLEMENT

Placebo capsule delivered orally once daily

Placebo

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 40-75 years.
  • BMI: 20-34.9 kg/m².
  • Able and willing to sign informed consent and participate for the study duration.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MusB Research LLC

New Port Richey, Florida, 34638, United States

RECRUITING

Central Study Contacts

Shalini Jain, PhD

CONTACT

813-419-0781jains@musbresearch.com

Indushekar Manjunatha

CONTACT

imanjunatha@musbresearch.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2026

First Posted

February 12, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)