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| Name | Class |
|---|---|
| Analyze & Realize | NETWORK |
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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
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),
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | Humiome Post LB (Postbiotic) : 340mg in 2 identical capsules per day orally |
|
| Placebo | Placebo Comparator | Microcrystalline in 2 identical capsules per day orally |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Humiome Post LB (Postbiotic) | Dietary Supplement | Heat-inactivated lactobacilli with fermented medium (a postbiotic) in 340mg powder format |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on stress (adjusted to baseline) | 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 | Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4) |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on Musculoskeletal strength | 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). | Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4) |
Inclusion Criteria
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liana Vismane, DR | Contact | +493040008122 | lvismane@a-r.com | |
| Natalie Doberstein | Contact | +493040008156 | ndoberstein@a-r.com |
| Name | Affiliation | Role |
|---|---|---|
| Mehdi Sadaghian, PhD | dsm-firmenich Switzerland AG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis | Recruiting | Paris | 75012 | France |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C100843 | Lacteol |
| C109691 | microcrystalline cellulose |
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Parallel Assignment A randomized, placebo-controlled, double-blind
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Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
| Placebo | Dietary Supplement | Microcrystalline cellulose, 340mg powder format |
|
|
| Effect on stress (within the group) | 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 | (Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4) |
| Effect on stress (within the group, compared to baseline) | 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. | (Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4) |
| Effect on indicators of Anxiety | 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 | Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4) |
| Effect on indicators of perceived stress | 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, | Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4) |
| Effect on Indicators of cognition and memory | 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 | Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4) |
| Effect on indicators of Chronic inflammation (hs-CRP) in blood | 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. | Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4) |
| Effect on indicators of Chronic inflammation (homocysteine) in blood | 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. | Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4) |
| Effect on indicators of Chronic inflammation (BDNF) in blood | 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. | Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4) |
| Effect on indicators of Chronic inflammation (IL-11) in blood | 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. | Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4) |
| Effect on indicators of Chronic inflammation (IL-6) in blood | 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. | Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4) |
| Effect on indicators of Chronic inflammation (IL-10) in blood | 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. | Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4) |
| Effect on indicators of Chronic inflammation (TNF-α) in blood | 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. | Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4) |
| Effect on indicators of Chronic inflammation in feces | 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 | Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4) |
| Effect on Visual-motor coordination |
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". |
| Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4) |
| Effect on Indicators of general health and well-being | 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, | Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4) |
| Effect on Indicators of sleeping quality status | 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 | Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4) |
| Effect on gastrointestinal function | 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) | Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4) |
| Effect on Glycemic status (Blood insulin) | 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. | Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4) |
| Effect on Glycemic status (Glucose levels) | 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. | Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4) |
| Effect on indicators of insulin resistance | 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. | Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4) |
| Effect on Blood lipid levels | 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) | Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4) |
| Effect on Body weight | 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) | Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4) |
| Effect on Microbiome composition | 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. | Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4) |
| Effect on Microbiome diversity | 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. | Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4) |
| Effect on fecal metabolomic profile | 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. | Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4) |
| Effect on Fecal organic acid levels | 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) | Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4) |
| Biofortis | Recruiting | Saint-Herblain | 44800 | France |
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| analyze & realize GmbH | Recruiting | Berlin | 10369 | Germany |
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