Private Wellness Study – (Psilo-Shakes) Summary #0315-2026 011

1. Study Objective
   The primary objective of this private wellness study was to evaluate the safety, tolerability, and effectiveness of Psilo-Shakes, a fungi-based protein breakfast formulation derived from psilocybe cubensis, in alleviating symptoms associated with Fibromyalgia.

Secondary Objectives: Functional Impact on Fibromyalgia

In addition, the study placed significant emphasis on secondary outcomes related to daily functioning and quality of life areas profoundly affected in individuals with Fibromyalgia. These secondary objectives aimed to capture the broader, real-world impact of Psilo-Shakes beyond pain mitigation alone.

Energy Regulation and Fatigue Reduction
Chronic fatigue is a defining and often debilitating feature of Fibromyalgia. The study evaluated whether sustained daily intake of Psilo-Shakes contributed to more stable energy levels throughout the day. Particular attention was given to reductions in mid-day energy crashes, improvements in morning alertness, and participants’ ability to maintain consistent activity without requiring extended rest periods.

Sleep Quality and Recovery Cycles
Disrupted and non-restorative sleep is strongly associated with symptom severity in Fibromyalgia. The study assessed changes in both subjective and device-measured sleep parameters, including sleep duration, sleep continuity, and perceived restfulness upon waking. Improvements in sleep were also examined in relation to next-day symptom expression, particularly pain sensitivity and cognitive clarity.

Functional Mobility and Physical Capacity
Participants were monitored for changes in their ability to perform routine physical activities such as walking, standing for extended periods, and completing daily tasks. This included evaluating reductions in movement-related discomfort, increased endurance, and improvements in fluidity of motion. Functional mobility was considered a key indicator of regained independence and overall physical resilience.

Cognitive Clarity and Daily Function (“Fibro Fog”)
Although not a primary endpoint, the study also tracked participant-reported changes in cognitive symptoms commonly referred to as “fibro fog.” This included attention span, memory recall, and the ability to complete tasks without mental fatigue, as these factors significantly influence day-to-day functioning.

Overall Quality of Life
A composite view of well-being was assessed through participant self-reporting, integrating physical comfort, emotional stability, productivity, and social engagement. Improvements in this domain were considered indicative of meaningful, holistic benefit.

2. Study Design
   This investigation was conducted as an open-label, controlled observational trial over a four-week period. While not blinded, the study maintained consistent monitoring protocols and standardized reporting measures to ensure reliability of observed outcomes.
3. Participants
   The study enrolled 10 adult participants diagnosed with Fibromyalgia.

• Age range: 28–62 years
• Gender distribution: 8 female, 2 male
• Inclusion criteria: clinically diagnosed Fibromyalgia, stable baseline health status
• Exclusion criteria: severe comorbid conditions, active medication changes, known food allergies related to fungi & milk proteins

4. Intervention
   Participants consumed one serving of Psilo-Shakes daily as a morning meal replacement. Each serving contained a standardized dose of psilocybe cubensis combined with a balanced protein complex designed for sustained metabolic support.
5. Control or Comparison
   Participants’ baseline symptom levels, recorded prior to the intervention, served as the primary comparison metric. No placebo group was included in this preliminary study phase.
6. Outcome Measures

Primary Outcomes:

• Reduction in widespread musculoskeletal pain
• Decrease in fatigue severity

Secondary Outcomes:

• Improvement in sleep quality and duration
• Increased daytime energy levels
• Enhanced physical mobility and daily functioning
• Self-reported quality of life improvements

7. Data Collection Methods
   Data was collected through a combination of:

• Weekly symptom self-assessment questionnaires
• Sleep tracking via wearable monitoring devices
• Periodic clinical evaluations
• Participant journals documenting daily energy and discomfort levels

8. Safety Monitoring
   All participants were monitored for adverse effects throughout the study duration. Observations included digestive tolerance, allergic reactions, and general physiological responses.
9. Statistical Analysis
   Given the small cohort size, analysis focused on descriptive statistics and within-subject comparisons from baseline to study conclusion. Trends were evaluated for consistency across participants rather than statistical generalization.
10. Results and Conclusions
    The study demonstrated that most participants experienced some measurable improvements in key Fibromyalgia symptoms. Notable outcomes included reduced pain intensity, improved sleep quality, and some enhanced mobility.

Psilo-Shakes were well tolerated, with only minor and transient digestive adjustments reported in two participants during the initial phase. No serious adverse effects were observed.

While limited by its small sample size and lack of placebo control, the study concluded that Psilo-Shakes show potential as a safe and effective nutritional adjunct for managing Fibromyalgia symptoms. These findings support further large-scale, controlled trials to validate efficacy and expand clinical application.

Summary Statement:
Psilo-Shakes represent a promising advancement in fungi-based therapeutic nutrition, marking an early but significant step toward integrative dietary interventions for chronic pain conditions. :::