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

NCT07471659 | Recruiting

• 1 other identifier: 2024-06-09-POST
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Stress

Keywords

stress; wellbeing; healthy aging; postbiotic; microbiome

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is the Perceived Symtoms of Stress 10 (PSS10) questionnaire, which assesses perceived levels of stress

  The PSS-10 questionnaire is a validated tool to assess self-reported levels of stress. It was originally developed in 1988 by Cohen and Williamson and published in "The social psychology of health" (pp. 31-67). S. Spacapan \& S. Oskamp (Eds.), Newbury Park, CA: Sage.

  PSS-10 will be assessed at baseline and at study end, 12 weeks later

Secondary Outcomes (6)

• Perceived stress (PSS-10) after 6 weeks

  Week 6 of 12

• Sleep quality after 6 and 12 weeks, assessed with the SHI (Sleep Hygiene Index) questionnaire

  Baseline, week 6 and week 12 (study end)

• Digestive health after 6 and 12 weeks

  Baseline, week 6 and week 12

• Depression, Anxiety and Stress

  Baseline, 6 and 12 weeks.

• Stool frequencies

  Assessed at baseline, week 6, and week 12

Other Outcomes (1)

• Gut Microbiome diversity and function after 6 and 12 weeks

  Baseline and weeks 6 and 12

Study Arms (2)

Active Treatment

EXPERIMENTAL

One-hundred participants will be randomized to the active treatment (verum) arm. Participants receive 2 capsules per day, taken simultaneously after breakfast, to provide a daily dose of 340 mg HPLB consistent with 10 billion heat-inactivated bacterial cell bodies. The opaque capsules are size 0 and produced from plant-based material (Hydroxy-Propyl Methyl Cellulose). Each capsule contains 2 mg Magnesium Stearate used as flowing agent for capsule filling.

Dietary Supplement: Humiome Post LB

Placebo

PLACEBO COMPARATOR

One-hundred participants will be randomized to the control arm and will receive placebo. Participants receive 2 capsules per day, taken simultaneously after breakfast, to provide a daily dose of 340 mg microcrystalline cellulose. The opaque capsules are size 0 and produced from plant-based material (Hydroxy-Propyl Methyl Cellulose). Each capsule contains 2 mg Magnesium Stearate used as flowing agent for capsule filling.

Other: Microcrystalline Cellulose

Interventions

Humiome Post LB DIETARY_SUPPLEMENT

Humiome Post LB is a postbiotic preparation according to the 2021 ISAPP definition (PMID: 33948025). It contains heat-treated co-fermented Limosilactobacillus fermentum (CNCM I-4831) and Lactobacillus delbrueckii ssp. lactis (CNCM I-4831), dried together with heat-treated spent fermentation medium on lactose as carrier.

Active Treatment

Microcrystalline Cellulose OTHER

MCC is typically sourced from wood pulp, or it can be chemically synthesized. It consists of linear chains of glucose, which are interlinked with β1,4-glycosidic bonds and cannot be broken by digestive enzymes. It is a very poor substrate for gut micro-organisms and is thus a good material to serve as placebo.

Also known as: MCC

Placebo

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged between 50 and 75 years old (limits included),
• Body mass index (BMI) ≥ 18.5 and \< 30 kg/m²
• Presenting a level of psychological stress characterized by a PSS-10 score ≥ 14 and ≤ 26,
• For women: not at risk of pregnancy (as per definitions of Appendix 13) Participants currently of childbearing potential, using an effective method of contraception.
• Menopausal without hormone replacement therapy (estrogenic replacement therapy stopped since more than 3 months can be included)
• Good general and mental health according to the opinion of the investigator: No relevant abnormalities from medical history nor from the medical consultation
• Agreeing to maintain lifestyle habits during the study (same dietary and physical activity habits)
• Able and willing to participate to the trial by complying with the protocol procedures as evidenced by a dated and signed ICF
• Affiliated with a social security scheme,
• With access to a health-care provider, who can be contacted by the CRO, and who reside in areas with available emergency health services,
• Agreeing to be registered in the national database of subjects participating in clinical research,
• Having a smartphone or personal computer compatible with the eConsult and ePRO applications.

You may not qualify if:

• Suffering from a metabolic disorder such as treated or untreated diabetes,
• Suffering from thyroid dysfunction, high blood pressure or other metabolic disorders treated for less than 6 months and/or non-stabilized,
• Suffering from a severe chronic disease: cancer, HIV, renal failure, hepatic or biliary disorders ongoing (except for cholecystectomy since more than two years and asymptomatic), chronic inflammatory digestive disease, arthritis or other chronic respiratory trouble (except for mild asthma under treatment),
• Suffering from GI disorders found to be inconsistent with the conduct of the study by the investigator (e.g. celiac disease, Chron's disease, etc.),
• With a known food allergy or intolerance or hypersensitivity to any of the trial products' ingredients,
• Women who are pregnant or lactating or intend on becoming pregnant within the following six months,
• Having a history or presence of a psychiatric or neurologic disease including epilepsy, cerebrovascular disturbance, traumatic brain injury, dementia, Alzheimer's Disease, clinical depression, or other clinically significant psychiatric/neurologic condition that could interfere with the interpretation of the study results in the opinion of the investigator,
• Having recently experienced or currently experiencing a significant stress as per investigator's judgment (e.g. grieving, divorce, moving, etc.),
• Having a condition and/or receiving a treatment that may cause immunosuppression (e.g.: under immunomodulating treatment for HIV infection, allograft, auto-immune disease or cancer, etc.)
• Under treatment or dietary supplement which could significantly affect parameter(s) followed during the trial according to the investigator or stopped less than one month prior to V1,
• Under treatment with one or more of the following treatments stopped less than one month prior to V1:
• psychotropic medications (including antidepressants and tranquilizers), stimulant medications, and/or narcotics having an effect on stress, sleep aid medications, supplements, and/or products, including antihistamines, acid-blocking medication (e.g., proton pump inhibitor, H2 blocker),
• Under treatment with an effect on the microbiome such as antibiotics stopped less than one month prior to V1,
• Having a lifestyle deemed incompatible with the trial according to the Investigator as described below:
• Practicing a high-level of physical activity (defined as more than 10 hours of intense physical activity a week, walking excluded),

Sponsors & Collaborators

• dsm-firmenich Switzerland AG: lead
• BioFortis: collaborator

Study Sites (1)

Biofortis

Saint-Herblain, 44800, France

RECRUITING

MeSH Terms

Interventions

microcrystalline cellulose

Study Officials

• Erik Eckhardt, PhD

  dsm-firmenich Houdan

  STUDY DIRECTOR

Central Study Contacts

Eleonora Rossi, PhD

CONTACT

+33 240205799; eleonora.rossi@biofortis.fr

Erik Eckhardt, PhD

CONTACT

+33 659328475; erik.eckhardt@dsm-firmenich.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled parallel intervention trial

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

FR (1)