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NCT Number: NCT07110896

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

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

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Key information

Conditions

Healthy Aging Anxiety Disorders Mental Disorders

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biofortis, Paris, France

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About this study

A double-blinded, randomised and placebo-controlled study will be conducted 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 for baseline in study participants when compared to placebo.

The study will be in healthy subjects who are getting older (ageing population) and will measure factors such as stress, sleep, anxiety as well as gut microbiome. The intervention period will be 90 days, and study will include 236 subjects in two arms (active and placebo),

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Humiome Post LB (Postbiotic)

Dietary Supplement

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

Other names: Lactobacillus LB

Placebo

Dietary Supplement

Microcrystalline cellulose, 340mg powder format

Other names: microcrystalline cellulose

Primary outcomes

  1. Effect on stress

    Time frame: Timeframe - Day 0 (V2), and Day 90 (V4)

    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

Secondary outcomes

  1. Effect on stress (adjusted to baseline)

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

    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. Lowest Value: 0, Highest Value: 42. A higher score means a worse outcome

  2. Effect on stress (within the group)

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

    To assess the effect of 3 months of daily consumption of Humiome® Post LB on change in DASS-21 subscores of stress, depression, anxiety in study participants when compared to placebo (between group comparison) and baseline (withingroup comparison). Lowest Value: 0, Highest Value: 42. A higher score means a worse outcome

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

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

    To assess the effect of 3 months of daily consumption of Humiome® Post LB and Placebo on stress measured by the DASS-21 in study participants when compared to baseline. Lowest Value: 0, Highest Value: 42. A higher score means a worse outcome.

  4. Effect on indicators of Anxiety

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

    To assess the effect of 3 months of daily consumption of Humiome® Post LB on indicators of anxiety when compared to placebo and baseline . The GAD-7 total score (range 0-21, expressed in a.u.) will be used to assess indicators of anxiety. Lowest Value: 0 Highest Value: 21. A higher score means a worse outcome

  5. Effect on indicators of perceived stress

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

    To assess the effect of 3 months of daily consumption of Humiome® Post LB on indicators of perceived stress when compared to placebo and baseline. The PSS-10 total score (range 0-40; expressed in a.u.) will be used to assess indicators of perceived stress. Lowest Value: 0, Highest Value: 40. A higher score means a worse outcome,

  6. Effect on Indicators of cognition and memory

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

    To assess the effect of 3 months of daily consumption of Humiome® Post LB on indicators of Indicators of cognition and memory when compared to placebo and baseline. Cogstate International Digit Symbol Substitution Test (symbols) will be used to test domains processing speed test, assesses focused attention and aspects of executive functioning; the outcome is the total number of correct responses

  7. Effect on indicators of Chronic inflammation (hs-CRP) in blood

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

    To assess the effect of 3 months of daily consumption of Humiome® Post LB on indicators of Chronic inflammation in blood when compared to placebo and baseline. For this hs-CRP levels in blood will be measured.

  8. Effect on indicators of Chronic inflammation (homocysteine) in blood

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

    To assess the effect of 3 months of daily consumption of Humiome® Post LB on indicators of Indicators of Chronic inflammation in blood when compared to placebo and baseline. For this homocysteine levels in blood, will be measured.

  9. Effect on indicators of Chronic inflammation (BDNF) in blood

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

    To assess the effect of 3 months of daily consumption of Humiome® Post LB on indicators of Indicators of Chronic inflammation in blood when compared to placebo and baseline. For this BDNF (brain-derived neurotrophic factor protein) in blood will be measured.

  10. Effect on indicators of Chronic inflammation (IL-11) in blood

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

    To assess the effect of 3 months of daily consumption of Humiome® Post LB on indicators of Indicators of Chronic inflammation in blood when compared to placebo and baseline. For this IL-11 levels in blood will be measured.

  11. Effect on indicators of Chronic inflammation (IL-6) in blood

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

    To assess the effect of 3 months of daily consumption of Humiome® Post LB on indicators of Indicators of Chronic inflammation in blood when compared to placebo and baseline. For this, IL-6 levels in blood will be measured.

  12. Effect on indicators of Chronic inflammation (IL-10) in blood

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

    To assess the effect of 3 months of daily consumption of Humiome® Post LB on indicators of Indicators of Chronic inflammation in blood when compared to placebo and baseline. For this IL-10 levels in blood will be measured.

  13. Effect on indicators of Chronic inflammation (TNF-α) in blood

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

    To assess the effect of 3 months of daily consumption of Humiome® Post LB on indicators of Indicators of Chronic inflammation in blood when compared to placebo and baseline. For this TNF-α levels in blood will be measured.

  14. Effect on indicators of Chronic inflammation in feces

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

    To assess the effect of 3 months of daily consumption of Humiome® Post LB on indicators of Indicators of Chronic inflammation in feces when compared to placebo and baseline. For this Calprotectin levels in feces will be measured

Other outcomes

  1. Effect on Musculoskeletal strength

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

    To assess the effect of 3 months of daily consumption of Humiome® Post LB on the Musculoskeletal strength when compared to placebo and baseline. Musculoskeletal strength will measured by grip strength using a hand dynamometer (dominant arm) (expressed in kg).

  2. Effect on Visual-motor coordination

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

    To assess the effect of 3 months of daily consumption of Humiome® Post LB on Visual-motor coordination when compared to placebo and baseline. Visual-motor coordination of study participants (expressed in seconds) will be measured by the "Manipulation and Dexterity Test - Pegboard".

  3. Effect on Indicators of general health and well-being

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

    To assess the effect of 3 months of daily consumption of Humiome® Post LB on Indicators of general health and well-being when compared to placebo and baseline.

    The SF-12 will be used to assess general health and well-being: physical component summary and mental component summary scales (T score, expressed in a.u.). Lowest Value: 0, Highest Value: 100. A higher score means a better outcome,

  4. Effect on Indicators of sleeping quality status

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

    To assess the effect of 3 months of daily consumption of Humiome® Post LB on Indicators of sleeping quality status when compared to placebo and baseline.

    The PSQI global score will be used to assess sleep quality (expressed in a.u., range 0-21). Lowest Value: 0, Highest Value: 21. A higher score means a worse outcome

  5. Effect on gastrointestinal function

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

    To assess the effect of 3 months of daily consumption of Humiome® Post LB on gastrointestinal function when compared to placebo and baseline.

    The GSRS (Gastrointestinal Symptom Rating Scale) will be used to assess the participants' gastrointestinal function (5 subscores) (expressed in a.u., range 1-7)

  6. Effect on Glycemic status (Blood insulin)

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

    To assess the effect of 3 months of daily consumption of Humiome® Post LB on Glycemic status when compared to placebo and baseline. For this, blood Insulin levels will be measured.

  7. Effect on Glycemic status (Glucose levels)

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

    To assess the effect of 3 months of daily consumption of Humiome® Post LB on Glycemic status when compared to placebo and baseline. For this, blood glucose levels will be measured.

  8. Effect on indicators of insulin resistance

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

    To assess the effect of 3 months of daily consumption of Humiome® Post LB on insulin resistance when compared to placebo and baseline. For this (HOMA-IR technique) (expressed in a.u.) will be used.

  9. Effect on Blood lipid levels

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

    To assess the effect of 3 months of daily consumption of Humiome® Post LB on Blood lipid levels when compared to placebo (between group comparison) and baseline (within group comparison)

  10. Effect on Body weight

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

    To assess the effect of 3 months of daily consumption of Humiome® Post LB on Body weight when compared to placebo (between group comparison) and baseline (within group comparison)

  11. Effect on Microbiome composition

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

    To assess the effect of 3 months of daily consumption of Humiome® Post LB on Microbiome composition when compared to placebo and baseline. Microbiome composition will be measured using full shotgun sequencing.

  12. Effect on Microbiome diversity

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

    To assess the effect of 3 months of daily consumption of Humiome® Post LB on Microbiome diversity when compared to placebo and baseline. Microbiome diversity will be measured using full shotgun sequencing.

  13. Effect on fecal metabolomic profile

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

    To assess the effect of 3 months of daily consumption of Humiome® Post LB on fecal metabolomic profile when compared to placebo and baseline. Metabolomic profile will be analyzed using semi-polar liquid chromatography-mass spectrometry (LC-MS)/MS method.

  14. Effect on Fecal organic acid levels

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

    To assess the effect of 3 months of daily consumption of Humiome® Post LB on Fecal organic acid levels when compared to placebo (between group comparison) and baseline (within group comparison)

Study contacts

Contact information is provided by the study sponsor or research team.

Liana Vismane, DR

CONTACT

[email protected]

+493040008122

Natalie Doberstein

CONTACT

[email protected]

+493040008156

Sponsors and collaborators

Lead sponsor

dsm-firmenich Switzerland AG

Industry

Collaborators

  • Analyze & Realize

Registry information

Official study title

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

Acronym: AnexLB

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 8, 2025
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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