iVS-1 Probiotic Intervention Targeting Biological Aging in Midlife Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorSynbiotic Health
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 40-75 years.
BMI: 20-34.9 kg/m².
Able and willing to sign informed consent and participate for the study duration.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Bifidobacterium adolescentis iVS-1
Dietary supplementB. adolescentis iVS-1 (probiotic capsule) delivered orally once daily at a minimum of 8 billion CFU/day
Placebo
Dietary supplementPlacebo capsule delivered orally once daily
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Bifidobacterium adolescentis iVS-1Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline to Day 150Secondary outcomes
1
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.
Time frame
Baseline to Day 1502
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.
Time frame
Baseline to Day 1503
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.
Time frame
Baseline to Day 1504
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.
Time frame
Baseline to Day 150Other outcomes
1
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.
Time frame
Baseline to Day 1502
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.
Time frame
Baseline to Day 1503
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.
Time frame
Baseline to Day 1504
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.
Time frame
Baseline to Day 150Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Synbiotic Health
Lead sponsor
MusB Research
Collaborator
Source ClinicalTrials.gov