Actively Recruiting

Phase Not Applicable
Age: 40Years - 75Years
All Genders
Healthy Volunteers
ID07407894

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

Age: 40Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

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

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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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