Actively Recruiting

Phase Not Applicable
Age: 50Years - 75Years
All Genders
Healthy Volunteers
NCT07110896

Study Evaluating the Effect of Humiome® Post LB on Stress, Anxiety, and Cognition in Aging Adults

Led by dsm-firmenich Switzerland AG · Updated on 2026-03-11

236

Participants Needed

3

Research Sites

65 weeks

Total Duration

On this page

Sponsors

D

dsm-firmenich Switzerland AG

Lead Sponsor

A

Analyze & Realize

Collaborating Sponsor

AI-Summary

What this Trial Is About

To assess the effect of 3 months of daily consumption of a postbiotic (inactivated lactic acid bacteria) Humiome® Post LB on stress measured by the Depression Anxiety Stress Scale-21 (DASS-21) adjusted on baseline in study participants when compared to placebo

CONDITIONS

Official Title

Study Evaluating the Effect of Humiome® Post LB on Stress, Anxiety, and Cognition in Aging Adults

Who Can Participate

Age: 50Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female participants aged 50 to 75 years inclusive
  • Body Mass Index (BMI) between 18.5 and 32 kg/m2
  • Generally in good health as judged by the investigator
  • Subjective mild to moderate memory complaints
  • Total score between 42 and 60 on the Depression Anxiety Stress Scale-21 (DASS-21) at baseline
  • Willing to maintain regular diet, exercise, medication, supplement, and nicotine habits during the study
  • Able to understand study procedures and provide informed consent
Not Eligible

You will not qualify if you...

  • History or presence of psychiatric or neurologic diseases that could affect study interpretation
  • Mini-Mental State Examination (MMSE) score below 21 at baseline
  • Chronic fatigue syndrome
  • For women, stress or anxiety clearly related to menopausal complaints
  • Started non-drug or non-supplement treatments for stress, anxiety, or memory complaints within 4 weeks prior to screening
  • Significant gastrointestinal, endocrine, cardiovascular, kidney, liver, lung, pancreas, neurologic, or biliary disorders affecting study results
  • Conditions likely to cause immunosuppression
  • History of gastrointestinal surgery except gallbladder or appendix removal
  • Uncontrolled high blood pressure at screening
  • Hearing or vision issues interfering with study tasks
  • Use of pre-, pro-, syn-, or post-biotic supplements within 90 days prior to screening
  • Use of psychotropic, stimulant, or narcotic medications within 4 weeks prior to screening
  • Major sleep disorders or recent use of sleep aids within 2 weeks prior to screening
  • Use of acid-blocking medications in the 30 days before study start, except ongoing use started 12 weeks before
  • Use of selective serotonin reuptake inhibitors (SSRIs) or benzodiazepines in the 30 days before study
  • History of cancer within 5 years
  • Allergy to study product components or standardized breakfast
  • Signs of active infection or recent antibiotic use within 30 days
  • Exposure to unregistered drug products within 30 days
  • Recent or potential illicit drug or excessive alcohol use
  • Women who are pregnant, breastfeeding, or of childbearing potential not using reliable contraception
  • Any condition interfering with consent, compliance, or study results interpretation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Biofortis

Paris, France, 75012

Actively Recruiting

2

Biofortis

Saint-Herblain, France, 44800

Actively Recruiting

3

analyze & realize GmbH

Berlin, Germany, 10369

Actively Recruiting

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Research Team

L

Liana Vismane, DR

CONTACT

N

Natalie Doberstein

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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