Humiome® Post LB for stress, anxiety, sleep, and thinking in older adults

A Randomized, Placebo-controlled, Double-blind Clinical Study to Evaluate the Effect of Humiome® Post LB on Stress, Anxiety, and Cognition in Aging Adults

This will test whether taking Humiome® Post LB every day for 90 days helps reduce stress and anxiety and improve sleep and memory in healthy adults aged 50–75.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 236 (estimated)
• Ages: 50 Years to 75 Years
• Sex: All
• Sponsor: dsm-firmenich Switzerland AG (industry)
• Locations: 3 sites (Paris and 2 other locations)
• Trial ID: NCT07110896 on ClinicalTrials.gov

What this trial studies

This double-blind, randomized, placebo-controlled trial will enroll 236 generally healthy adults aged 50–75 and randomize them to daily Humiome® Post LB (an inactivated lactic acid bacteria postbiotic) or placebo for 90 days. The primary outcome is change in stress measured by the DASS-21 adjusted for baseline; secondary measures include anxiety, sleep metrics, subjective memory complaints, and gut microbiome composition. Participants will provide baseline and follow-up assessments and biological samples at participating clinical sites in France and Germany. The study is sponsored by dsm-firmenich with laboratory collaboration from Biofortis and Analyze & Realize.

Who should consider this trial

Good fit: Ideal candidates are generally healthy men or women aged 50–75 with BMI 18.5–32 kg/m2, mild to moderate memory complaints, and a DASS-21 total score between 42 and 60 who can attend study visits and keep stable lifestyle habits.

Not a fit: People with severe psychiatric or neurological disorders, significant medical conditions, substantial cognitive impairment, those outside the age or BMI ranges, or with DASS-21 scores outside 42–60 are unlikely to benefit from this specific study.

Why it matters

Potential benefit: If effective, the product could reduce stress and anxiety and modestly improve sleep and subjective memory complaints in older adults.

How similar studies have performed: Small clinical studies and preclinical work on probiotics and postbiotics suggest potential mood and sleep benefits via the gut–brain axis, but evidence is mixed and large randomized trials in older adults are limited.

Eligibility criteria

Inclusion Criteria

1. Participant is male or female, 50-75 years of age, inclusive.
2. Participant has a Body Mass Index (BMI) of ≥18.5 kg/m2 to 32 kg/m2.
3. Participant is generally in good health, as per investigator's judgement at V1.
4. Participant has subjective mild to moderate memory complaints, as per investigator's judgement.
5. Participant has a total score of ≥42 and ≤60 on the DASS-21 administered at V1.
6. 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.
7. 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.

7\. 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.

Exclusion criteria:

1. 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.
2. MMSE score at V1 \< 21.
3. Chronic fatigue syndrome.
4. Women: elevated stress and/or anxiety levels clearly related to the (peri) menopause complaints, as per investigator judgement
5. 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.

7\. 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.

10\. Participant has an issue with hearing or seeing that might interfere with the tasks/questionnaires to be completed during the visits.

11\. Participant has used pre-, pro-, syn-, or post-biotic supplements within 90 days of screening.

12\. 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.

14\. 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.

16\. 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.

19\. 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).

20\. Participant has been exposed to any non-registered drug product within 30 days of the screening visit.

21\. 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).

22\. Women lactating, pregnant or of childbearing potential not using a reliable contraceptive method.

23\. Participant has a condition the investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.

Where this trial is running

Paris and 2 other locations

• Biofortis — Paris, France (RECRUITING)
• Biofortis — Saint-Herblain, France (RECRUITING)
• analyze & realize GmbH — Berlin, Germany (RECRUITING)

Study contacts

• Study coordinator: Liana Vismane, DR

Conditions: Healthy Aging, Healthy aging, Microbiome, Stress, Sleep, Anxiety, gut-brain