Actively Recruiting

Phase Not Applicable
Age: 50Years - 75Years
All Genders
Healthy Volunteers
NCT07471659

Effect of Daily Humiome® Post LB Intake on Wellbeing in Older Individuals With Moderate Stress Levels

Led by dsm-firmenich Switzerland AG · Updated on 2026-04-23

200

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

Sponsors

D

dsm-firmenich Switzerland AG

Lead Sponsor

B

BioFortis

Collaborating Sponsor

AI-Summary

What this Trial Is About

The placebo-controlled, double blind parallel intervention trial "PostWelLB" aims to test whether 3 months of daily supplementation with the postbiotic product "Humiome® Post LB" (HPLB; 340 mg / day) can reduce self-reported stress (PSS10 questionnaire)- in an older (50 - 75 years; all genders) population in France.

CONDITIONS

Official Title

Effect of Daily Humiome® Post LB Intake on Wellbeing in Older Individuals With Moderate Stress Levels

Who Can Participate

Age: 50Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women aged between 50 and 75 years old (limits included)
  • Body mass index (BMI) 8 18.5 and < 30 kg/m2
  • Presenting a level of psychological stress characterized by a PSS-10 score 8 14 and 8 26
  • For women: not at risk of pregnancy and using effective contraception if of childbearing potential
  • Menopausal women without hormone replacement therapy or stopped estrogenic replacement therapy more than 3 months ago
  • Good general and mental health with no relevant medical abnormalities
  • Agree to maintain current lifestyle habits during the study
  • Able and willing to comply with study procedures and sign informed consent
  • Affiliated with a social security scheme
  • Have access to a healthcare provider and emergency health services
  • Agree to be registered in the national clinical research database
  • Have a smartphone or personal computer compatible with study applications
Not Eligible

You will not qualify if you...

  • Suffering from metabolic disorders such as diabetes or thyroid dysfunction treated less than 6 months ago or unstable
  • Having severe chronic diseases including cancer, HIV, renal failure, liver or biliary disorders (except cholecystectomy over 2 years ago), chronic inflammatory digestive disease, arthritis, or chronic respiratory troubles except mild asthma under treatment
  • Having gastrointestinal disorders inconsistent with study conduct (e.g., celiac disease, Crohn's disease)
  • Known food allergies or intolerances to any study product ingredients
  • Pregnant, lactating, or planning pregnancy within six months
  • History or presence of psychiatric or neurologic diseases that could affect study results
  • Recent or current significant stress events as judged by investigator
  • Conditions or treatments causing immunosuppression
  • Recent use (less than one month) of treatments or supplements affecting study parameters, including psychotropic, stimulant, narcotic, sleep aid medications, antihistamines, acid-blocking medications, or antibiotics
  • Lifestyle incompatible with study, such as high physical activity over 10 hours per week, excessive alcohol consumption, or recent significant diet or activity changes
  • Personal history of significant eating disorders
  • Participation in another clinical trial or within exclusion period
  • Received clinical trial compensations equal or above 6000 Euros in last 12 months
  • Under legal protection or deprived of rights
  • Psychological or linguistic incapacity to consent or unreachable in emergencies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Biofortis

Saint-Herblain, France, 44800

Actively Recruiting

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Research Team

E

Eleonora Rossi, PhD

CONTACT

E

Erik Eckhardt, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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