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| Name | Class |
|---|---|
| MusB Research | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bifidobacterium adolescentis iVS-1 | Experimental | Probiotic Capsule |
|
| Placebo | Placebo Comparator | Placebo capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bifidobacterium adolescentis iVS-1 | Dietary Supplement | B. adolescentis iVS-1 (probiotic capsule) delivered orally once daily at a minimum of 8 billion CFU/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Day 150 |
| Change in Gut Microbiota Function |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shalini Jain, PhD | Contact | 813-419-0781 | jains@musbresearch.com | |
| Indushekar Manjunatha | Contact | imanjunatha@musbresearch.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MusB Research LLC | Recruiting | New Port Richey | Florida | 34638 | United States |
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| Placebo | Dietary Supplement | Placebo capsule delivered orally once daily |
|
| 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. | 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. | 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. | 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. | 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. | 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. | Baseline to Day 150 |
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. |
| Baseline to Day 150 |
| 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. | Baseline to Day 150 |
| 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. | Baseline to Day 150 |
| Change in Inflammatory Markers | Changes in inflammatory 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. | Baseline to Day 150 |