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| Name | Class |
|---|---|
| University of Colorado, Boulder | OTHER |
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The goal of this clinical trial is to learn if a novel strain of heat-killed Mycolicibacterium that is being considered by the International Code of Nomenclature of Prokaryotes (ICNP) as candidate species and type strain "Candidatus Mycolicibacterium petrae" KGA-10 (KGA-10) has effects on perceived stress, systemic inflammation, self-reported measures of sleep, and self-reported general well-being in healthy adults. This clinical trial will also learn about safety and tolerability of KGA-10. This novel Mycolicibacterium species is also referred to as NeuroAlly and MTC 0012. The questions it aims to answer are: 1) is KGA-10 associated with adverse side effects; 2) does KGA-10 reduce systemic inflammation; 3) does KGA-10 reduce perceived stress; 4) does KGA-10 improve self -reported measures of sleep; 4) does KGA-10 improve self-reported metrics of general wellbeing.
Researchers will compare daily KGA-10 (1 mg mixed with microcrystalline cellulose in capsule form) to a placebo (microcrystalline cellulose in capsule form, but contains no KGA-10) to see if KGA-10 has effects on the proposed outcomes.
Participants will take KGA-10 or a placebo everyday for 8 weeks and keep a daily log of their supplement intake that includes the time of day. Participants will complete a weekly survey to assess side effects experienced during the trial both related and not related to the supplement. They will complete additional weekly surveys evaluating perceived stress and self-reported measures of sleep. They will complete a survey evaluating self-reported general well-being and provide dried blood spot (DBS) samples to assess systemic inflammation at baseline, week-4, and week-8
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KGA-10 | Experimental | 1 mg of KGA-10 mixed with microcrystalline cellulose in size 1 capsule |
|
| Placebo | Placebo Comparator | Microcrystalline cellulose in size 1 capsule |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mycolicibacterium petrae KGA-10 (heat-killed) | Dietary Supplement | Heat-killed bacteria are considered postbiotics. At the time of registering this clinical trial, Mycolicibacterium petrae KGA-10 is being consider by the International Code of Nomenclature of Prokaryotes (ICNP) as candidate species and type strain therefore the proper nomenclature is "Candidatus Mycolicibacterium petrae" KGA-10. |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in C-reactive protein (CRP) from baseline at week 8 | Mean percent change from baseline will be calculated and compared between placebo and treatment groups. | From baseline measurement to completion of treatment at week-8. |
| Number of participants with treatment-related adverse events and serious adverse events as assessed by the Generic Assessment of Side Effects - Probiotics (GASE-P) | A symptom endorsement on the GASE-P was evaluated as an adverse event if it was "Severe", endorsed as related to the supplement, and not present in the baseline GASE-P evaluation. A serious adverse event was defined as any unexpected event resulting in death, life threatening illness, suicide attempt, hospitalization or prolonged hospitalization, and/or persistent/significant disability resulting from participation in the study. | From the first dose to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in perceived stress from baseline over the treatment period of 8 weeks | Perceived stress is being measured by the Perceived Stress Scale - 10 (PSS-10; score range: 0 to 40) with higher scores being attributed to higher perceived stress. | From the first dose to end of the treatment period at week-8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado, Boulder - WILD campus | Boulder | Colorado | 80301 | United States |
IPD that underlie the results will be made available upon request after signing NDA.
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|
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| Placebo (microcrystalline cellulose) | Dietary Supplement | Microcrystalline cellulose in size 1 capsule |
|
| Increase in general wellbeing from baseline over the treatment period of 8 weeks |
General wellbeing is being measured by the 36-Item Short Form Survey (SF-36; score range: 0 to 100) with higher score being attributed to better wellbeing. Subdomains will be individually assessed. |
| From the first dose to end of the treatment period at week-8 |
| Increase in self-reported sleep quality from baseline over the treatment period of 8 weeks | Sleep quality is being measured by the Pittsburgh Sleep Quality Index (PSQI; score range: 0 to 21) with higher score being attributed to worse sleep quality. Subdomains will be individually assessed. | From the first dose to end of the treatment period at week-8 |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C109691 | microcrystalline cellulose |
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