Healthy Aging
Conditions
Keywords
Healthy aging, Microbiome, Stress, Sleep, Anxiety, gut-brain
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
Detailed 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),
Interventions
DIETARY_SUPPLEMENTHumiome Post LB (Postbiotic)
Heat-inactivated lactobacilli with fermented medium (a postbiotic) in 340mg powder format
DIETARY_SUPPLEMENTPlacebo
Microcrystalline cellulose, 340mg powder format
Sponsors
dsm-firmenich Switzerland AG
Analyze & Realize
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention model description
Parallel Assignment A randomized, placebo-controlled, double-blind
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect on stress | 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
| Measure | Time frame | Description |
|---|---|---|
| Effect on stress (adjusted to baseline) | 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 |
| Effect on stress (within the group) | (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 |
| Effect on stress (within the group, compared to baseline) | (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. |
| Effect on indicators of Anxiety | 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 |
| Effect on indicators of perceived stress | 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, |
| Effect on Indicators of cognition and memory | 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 |
| Effect on indicators of Chronic inflammation (hs-CRP) in blood | 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. |
| Effect on indicators of Chronic inflammation (homocysteine) in blood | 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. |
| Effect on indicators of Chronic inflammation (BDNF) in blood | 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. |
| Effect on indicators of Chronic inflammation (IL-11) in blood | 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. |
| Effect on indicators of Chronic inflammation (IL-6) in blood | 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. |
| Effect on indicators of Chronic inflammation (IL-10) in blood | 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. |
| Effect on indicators of Chronic inflammation (TNF-α) in blood | 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. |
| Effect on indicators of Chronic inflammation in feces | 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 |
Countries
France, Germany
Contacts
CONTACTLiana Vismane, DR
CONTACTNatalie Doberstein
STUDY_DIRECTORMehdi Sadaghian, PhD
dsm-firmenich Switzerland AG
Outcome results
None listed