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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
107
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.
Microcrystalline cellulose in size 1 capsule
University of Colorado, Boulder - WILD campus
Boulder, Colorado, United States
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.
Time frame: 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.
Time frame: From the first dose to the end of treatment at 8 weeks
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.
Time frame: From the first dose to end of the treatment period at week-8
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.
Time frame: 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.
Time frame: From the first dose to end of the treatment period at week-8
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