RecruitingNot ApplicableNCT07407894

iVS-1 Probiotic Intervention Targeting Biological Aging in Midlife Adults

VITAL-Age Trial (iVS-1 Investigation for Targeting Aging and Longevity)


Sponsor

Synbiotic Health

Enrollment

80 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 75 Years

Inclusion Criteria3

  • Aged 40-75 years.
  • BMI: 20-34.9 kg/m².
  • Able and willing to sign informed consent and participate for the study duration.

Exclusion Criteria15

  • 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.

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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


Locations(1)

MusB Research LLC

New Port Richey, Florida, United States

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NCT07407894


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