Actively Recruiting
VITAL-Age Trial iVS-1 Investigation for Targeting Aging and Longevity
Led by Synbiotic Health · Updated on 2026-04-22
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Synbiotic Health
Lead Sponsor
M
MusB Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of Bifidobacterium adolescentis (iVS-1) supplementation on biological aging markers, metabolic health, and functional health outcomes in adults aged 40 to 75 years. The study explores how changes in the gut microbiome may influence aging-related biological pathways and overall health. Aging involves changes such as inflammation, cellular aging, mitochondrial function, and gut microbiome alterations, which this trial aims to address through probiotic intervention. Participants will be randomly assigned to receive either a probiotic capsule containing at least 8 billion CFU of Bifidobacterium adolescentis iVS-1 or a placebo capsule once daily for 150 days. This double-blind, placebo-controlled trial includes two groups: one taking the probiotic and one taking placebo. The study will collect blood and stool samples and use questionnaires to assess cognition, sleep quality, and quality of life at the start, mid-intervention, and at the end of the 150-day treatment period. During the study, participants will undergo various assessments including biological aging biomarkers, metabolic health measures, lipid profiles, and functional health outcomes. Researchers will monitor changes in cognitive function, sleep quality, and overall quality of life. The primary outcome is the change in biological aging biomarkers from baseline to day 150. This study allows for thorough monitoring of health changes over the treatment period to better understand the probiotic's impact on aging processes.
CONDITIONS
Brief Title
iVS-1 Probiotic Intervention Targeting Biological Aging in Midlife Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 40 to 75 years
- Body mass index (BMI) between 20 and 34.9 kg/m²
- Able and willing to sign informed consent
- Willing to participate for the full study duration
You will not qualify if you...
- History of chronic liver, kidney, or heart disease
- Current pregnancy or breastfeeding
- Colonoscopy or colonoscopy preparation within 4 weeks before screening
- Planning to have children during the study period
- Current use of probiotics, prebiotics, or metabolic-altering supplements
- Unable to cooperate with investigators or testing
- Known history or ongoing treatment of cancer
- Abuse of drugs, alcohol, tobacco, nicotine, or other substances
- History of cardiac diseases like atherosclerosis, heart failure, angina, or chronic hypoxic diseases
- History of major gastrointestinal diseases or intestinal surgeries
- Type 1 or 2 diabetes mellitus
- Poorly controlled chronic diseases such as hypertension or hyperlipidemia
- Vulnerable groups including clinically ill, mentally ill, cognitively impaired, minors, or illiterate
- Significant weight loss over 20% in the past month
- Any condition affecting safety or study outcome integrity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 150 days
Participants take a probiotic capsule or placebo capsule orally once daily for 150 days.
3 visits: baseline, mid-intervention, and end of study
Trial Site Locations
Total: 1 location
1
MusB Research LLC
New Port Richey, Florida, United States, 34638
Actively Recruiting
Research Team
S
Shalini Jain, PhD
I
Indushekar Manjunatha
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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