Anti Aging, Healthy Aging
Conditions
Keywords
Bifidobacterium adolescentis, iVS-1, Aging, Geroscience, Gut Microbiome, Probiotic, Healthspan
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.
Interventions
DIETARY_SUPPLEMENTBifidobacterium adolescentis iVS-1
B. adolescentis iVS-1 (probiotic capsule) delivered orally once daily at a minimum of 8 billion CFU/day
DIETARY_SUPPLEMENTPlacebo
Placebo capsule delivered orally once daily
Sponsors
Synbiotic Health
MusB Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 40-75 years. * BMI: 20-34.9 kg/m². * Able and willing to sign informed consent and participate for the study duration.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Biological Aging Biomarkers | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Phenotypic Age | Baseline to Day 150 | 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. |
| Change in Bifidobacterium adolescentis iVS-1 Abundance | Baseline to Day 150 | 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. |
| Change in Metabolic Health | Baseline to Day 150 | 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. |
| Change in Lipid Profiles | Baseline to Day 150 | 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. |
| Change in Cognitive Function | Baseline to Day 150 | 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. |
| Change in Sleep Quality | Baseline to Day 150 | 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. |
| Change in Quality of Life | Baseline to Day 150 | 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. |
Countries
United States
Contacts
CONTACTShalini Jain, PhD
CONTACTIndushekar Manjunatha
Outcome results
None listed