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

NCT07110896 | Recruiting

• 1 other identifier: 2024-09-06-ANEX
• Study Type: interventional
• Target: 236
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Healthy Aging

Keywords

Healthy aging; Microbiome; Stress; Sleep; Anxiety; gut-brain

Outcome Measures

Primary Outcomes (1)

• Effect on stress

  To assess the effect of 3 months of daily consumption of 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

  Timeframe - Day 0 (V2), and Day 90 (V4)

Secondary Outcomes (14)

• Effect on stress (adjusted to baseline)

  Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)

• Effect on stress (within the group)

  (Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)

• Effect on stress (within the group, compared to baseline)

  (Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)

• Effect on indicators of Anxiety

  Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)

• Effect on indicators of perceived stress

  Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)

Other Outcomes (14)

• Effect on Musculoskeletal strength

  Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)

• Effect on Visual-motor coordination

  Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)

• Effect on Indicators of general health and well-being

  Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)

Study Arms (2)

Active

ACTIVE COMPARATOR

Humiome Post LB (Postbiotic) : 340mg in 2 identical capsules per day orally

Dietary Supplement: Humiome Post LB (Postbiotic)

Placebo

PLACEBO COMPARATOR

Microcrystalline in 2 identical capsules per day orally

Dietary Supplement: Placebo

Interventions

Humiome Post LB (Postbiotic) DIETARY_SUPPLEMENT

Heat-inactivated lactobacilli with fermented medium (a postbiotic) in 340mg powder format

Also known as: Lactobacillus LB

Active

Placebo DIETARY_SUPPLEMENT

Microcrystalline cellulose, 340mg powder format

Also known as: microcrystalline cellulose

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:

• Participant is male or female, 50-75 years of age, inclusive.
• Participant has a Body Mass Index (BMI) of ≥18.5 kg/m2 to 32 kg/m2.
• Participant is generally in good health, as per investigator's judgement at V1.
• Participant has subjective mild to moderate memory complaints, as per investigator's judgement.
• Participant has a total score of ≥42 and ≤60 on the DASS-21 administered at V1.
• Participant is willing to maintain regular dietary, exercise, and allowed medication/supplement habits and smoking and other nicotine habits (if a smoker or nicotine user) for the duration of the study.
• Participant understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.
• \. Participant understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.

You may not qualify if:

• Participant has a history or presence of a psychiatric or neurologic disease including epilepsy, cerebrovascular disease, traumatic brain injury, dementia, Alzheimer's Disease, clinical depression, or other clinically significant psychiatric/neurologic condition that, in the opinion of the investigator, could interfere with the interpretation of the study results.
• MMSE score at V1 \< 21.
• Chronic fatigue syndrome.
• Women: elevated stress and/or anxiety levels clearly related to the (peri) menopause complaints, as per investigator judgement
• Non-pharmacological or non-supplementation options for management of stress, anxiety or memory/cognitive complaints (e.g. yoga, "brain jogging") started within 4 weeks of screening 6. Participant has a clinically significant gastrointestinal, endocrine, cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic, or biliary disorder that, in the opinion of the investigator, could interfere with the interpretation of the study results.
• \. Participant has a condition that would likely cause immunosuppression. 8. Participant has a history of gastrointestinal surgery (cholecystectomy and appendectomy are acceptable, considering the prevalence in the age group), as per investigator judgement. 9. Participant has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg) at screening.
• \. Participant has an issue with hearing or seeing that might interfere with the tasks/questionnaires to be completed during the visits.
• \. Participant has used pre-, pro-, syn-, or post-biotic supplements within 90 days of screening.
• \. Participant has a history of using psychotropic medications (including antidepressants and tranquilizers), stimulant medications, and/or narcotics within 4 weeks of screening. 13. Participants has major sleep disorder (severe insomnia) based on investigator's judgment.
• \. Participant has used sleep aid medications, supplements, and/or products, including antihistamines, within 2 weeks of screening (washout prior to screening is allowed). Sporadic use of supplementation of melatonin, valerian, passion flower, lavender, if needed, if this has been habitually or occasionally done prior to the study, is allowed. 15. Participant has used an acid-blocking medication (e.g., proton pump inhibitor, H2 blocker) in the past 30 days prior to study. However, any ongoing use started at least 12 weeks before Visit 1 is allowed.
• \. Participant has used selective serotonin reuptake inhibitors (SSRIs) or benzodiazepines in the past 30 days. (Note: Participants will not be excluded on the basis of a well-managed depressive disorder that does not require SSRIs.) 17. Participant has a history of cancer in the prior 5 years. 18. Participant has an allergy to any components of the IP or the standardized breakfast.
• \. Individual has signs or symptoms of an active infection of clinical significance or has taken antibiotics within 30 days prior to any visit (washout is permitted for re-scheduling of the clinic visit).
• \. Participant has been exposed to any non-registered drug product within 30 days of the screening visit.
• \. Participant has a current or recent history (within 12 months of screening) or strong potential for illicit drug or excessive alcohol intake defined as \>14 drinks per week (1 drink = 350 ml beer, 150 ml wine, or 40 ml hard liquor).
• \. Women lactating, pregnant or of childbearing potential not using a reliable contraceptive method.

Sponsors & Collaborators

• dsm-firmenich Switzerland AG: lead
• Analyze & Realize: collaborator

Study Sites (3)

Biofortis

Paris, 75012, France

RECRUITING

Biofortis

Saint-Herblain, 44800, France

RECRUITING

analyze & realize GmbH

Berlin, 10369, Germany

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Lacteol; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Mehdi Sadaghian, PhD

  dsm-firmenich Switzerland AG

  STUDY DIRECTOR

Central Study Contacts

Liana Vismane, DR

CONTACT

+493040008122; lvismane@a-r.com

Natalie Doberstein

CONTACT

+493040008156; ndoberstein@a-r.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment A randomized, placebo-controlled, double-blind

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: August 8, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

FR (2); DE (1)