Oral Supplementation With 1 mg of KGA-10 Daily (a Novel Environmentally-derived Mycolicibacterium) for Stress, Sleep, and Inflammation

Part of paid clinical trials in Boulder, Colorado.

Sponsor
Kioga Inc.
Study ID
NCT07604038
Status
Completed

Conditions

  • General Wellbeing
  • Safety
  • Sleep Quality
  • Stress Resilience
  • Systemic Inflammation

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • 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.
  • Placebo (microcrystalline cellulose) — DIETARY_SUPPLEMENT
    Microcrystalline cellulose in size 1 capsule

Study Details

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

Key Dates

Start date
Aug 14, 2025
Status verified
May 2026
Primary completion
Jan 15, 2026
Completion
Jan 15, 2026

Study Design

Enrollment
107 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: KGA-10
    1 mg of KGA-10 mixed with microcrystalline cellulose in size 1 capsule
  • Placebo Comparator: Placebo
    Microcrystalline cellulose in size 1 capsule

Primary Outcome Measure

Decrease in C-reactive protein (CRP) from baseline at week 8 [ Time Frame: From baseline measurement to completion of treatment at week-8. ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado, Boulder - WILD campusBoulderColorado80301-

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By research site
University of Colorado, Boulder - WILD campus· Boulder, CO

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