Healthy AgingVITALNCT07407894
iVS-1 Probiotic Intervention Targeting Biological Aging in Midlife Adults
A study testing Bifidobacterium adolescentis iVS-1 in people with Healthy Aging and Anti Aging, run by Synbiotic Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging, Anti Aging
- What is being tested?
- Bifidobacterium adolescentis iVS-1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 40-75 years.
- BMI: 20-34.9 kg/m².
- Able and willing to sign informed consent and participate for the study duration.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indushekar Manjunatha contact
United States1 site, 1 recruiting
- Recruiting
MusB Research LLC
New Port Richey, Florida, 34638
Shalini Jain, PhD, 813-419-0781, jains@musbresearch.com
Shalini Jain, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Aging, Anti Aging
- Being tested
- Bifidobacterium adolescentis iVS-1, Placebo
- Keywords
- Bifidobacterium adolescentis, iVS-1, Aging, Geroscience, Gut Microbiome, Probiotic, Healthspan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium adolescentis iVS-1Dietary supplement
- adolescentis iVS-1 (probiotic capsule) delivered orally once daily at a minimum of 8 billion CFU/day
PlaceboDietary supplement
Placebo capsule delivered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Bifidobacterium adolescentis iVS-1 | Experimental | Probiotic Capsule Receives: Dietary Supplement: Bifidobacterium adolescentis iVS-1 |
| Placebo | Placebo comparator | Placebo capsule Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Day 150
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Day 150
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Feb 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Synbiotic Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MusB Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407894
- Sponsor's protocol ID
- MB-VITAL
- Acronym
- VITAL
- Status last verified
- Apr 2026
- First submitted
- 28 Jan 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VITAL-Age Trial (iVS-1 Investigation for Targeting Aging and Longevity)
- ClinicalTrials.gov ID
- NCT07407894
- Acronym / sponsor ID
- VITAL / MB-VITAL
- Conditions
- Healthy Aging, Anti Aging
- Keywords
- Bifidobacterium adolescentis, iVS-1, Aging, Geroscience, Gut Microbiome, Probiotic, Healthspan
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Synbiotic HealthIndustry (pharma, biotech, devices)
- Collaborators
- MusB Research
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bifidobacterium adolescentis iVS-1 | Experimental | Dietary Supplement: Bifidobacterium adolescentis iVS-1Probiotic Capsule |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo capsule |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 40-75 years.
- BMI: 20-34.9 kg/m².
- Able and willing to sign informed consent and participate for the study duration.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bifidobacterium adolescentis iVS-1B. adolescentis iVS-1 (probiotic capsule) delivered orally once daily at a minimum of 8 billion CFU/day | Dietary supplement | Bifidobacterium adolescentis iVS-1 |
| PlaceboPlacebo capsule delivered orally once daily | Dietary supplement | Placebo |
Primary outcome
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.
7 secondary outcomes
Change in Phenotypic Age
Time frame: Baseline to Day 150
Change in Bifidobacterium adolescentis iVS-1 Abundance
Time frame: Baseline to Day 150
Change in Metabolic Health
Time frame: Baseline to Day 150
Change in Lipid Profiles
Time frame: Baseline to Day 150
Change in Cognitive Function
Time frame: Baseline to Day 150
Change in Sleep Quality
Time frame: Baseline to Day 150
Change in Quality of Life
Time frame: Baseline to Day 150
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Indushekar Manjunatha contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bifidobacterium adolescentis iVS-1 in people with Healthy Aging and Anti Aging, run by Synbiotic Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shalini Jain, PhD (813-419-0781, jains@musbresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Biological Aging Biomarkers (time frame: Baseline to Day 150). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.