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.
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
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
80
B. adolescentis iVS-1 (probiotic capsule) delivered orally once daily at a minimum of 8 billion CFU/day
Placebo capsule delivered orally once daily
MusB Research LLC
New Port Richey, Florida, United States
RECRUITINGChange 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 150
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 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Day 150
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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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Day 150