Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:57 AM
Study NCT ID:
NCT07407894
Status:
RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
iVS-1 Probiotic Intervention Targeting Biological Aging in Midlife Adults
Sponsor:
Synbiotic Health
Organization:
Study Overview
Official Title:
VITAL-Age Trial (iVS-1 Investigation for Targeting Aging and Longevity)
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VITAL
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: