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

DSM Nutritional Products

Status: Not yet enrolling

Conditions: Healthy Aging

Treatments: Dietary Supplement: Humiome Post LB (Postbiotic); Dietary Supplement: Placebo

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT07110896

2024-09-06-ANEX

Details and patient eligibility

About

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

Full description

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),

Enrollment: 236 estimated patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

8. 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.

6. 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.

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

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

9. 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.

10. 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.

11. 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.

12. 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).

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

14. 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).

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

16. 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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236 participants in 2 patient groups, including a placebo group

Active

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Humiome Post LB (Postbiotic)

Placebo

Placebo Comparator group

Description:

Microcrystalline in 2 identical capsules per day orally

Treatment:

Dietary Supplement: Placebo