Research & Peer Review Studies

NEURO47: SINGLE BLIND CLINICAL STUDY TO EXPLORE THE EFFECT OF KENRICO SAP SHEET ON THETA BRAINWAVES (March 12, 2025)

Treatment investigated: KENRICO MEGA GOLD 17000 mg, KENRICO SUPREME GOLD EDITION TRMX 5 50TH ANNIVERSARY 8500 mg
Device used in clinical study: EEG
Number of participants: 1000 participants

Background: This study investigates the effect of a SPOROLIFE skin patch versus a patch without SPOROLIFE on the brain's transition from wakefulness to sleep. This transition is marked by theta wave activity (4–7 Hz) exceeding 51% of total brain activity, a phase typically lasting 1 to 5 minutes or 2–5% of total sleep time. The shift to theta dominance is a normal part of sleep onset and is tracked as the Rate Score (%). Amplitudes are tracked as the Mean Score (uV). Amplitudes between 20 to 50 uV are considered optimal for smooth sleep transitions, while amplitudes below 20 uV may indicate difficulty falling asleep. Amplitudes above 100 uV may suggest sleep instability or neurological concerns. Brain activity was recorded using EEG neuroimaging over a five-day period involving 1,000 participants of varying genders and ages.

Device used in the clinical study: An electroencephalography (EEG) (elek-tro-in-SEF-all-oh-gram), is a neurological test that measures the electrical signals your brain sends to the rest of your body, and then records them onto a graph. An EEG is used to evaluate the cause of seizures, diagnose comas, and evaluate strokes and sleep disorders. It can also be used to determine the presence and location of brain injuries, abscesses, tumors, intracranial hemorrhages, and to confirm brain death.

Participants: A single blind clinical study over 1,000 participants was conducted in triple site centers. The safety of the study was carefully analyzed with risk matrix from ISO 14971 prior to clinical study and deemed acceptable to progress. A deep screening was conducted at the beginning of the study to ensure 100% participant retention.

Methodology: The experimental groups were exposed to five articles over a five-day period as follows:

• Day 1: No treatment.
• Day 2: Placebo Control (Blank).
• Day 3: Mega Gold Treatment.
• Day 4: TRMX 5 50th Anniversary Treatment.
• Day 5: Other brand Treatment (No Sporolife).

The formulations varied across the treatments to ensure a clear comparison. The Placebo Control contained blank pads with no composition, while the Mega Gold Treatment included 5000 mg of Generation 5th Sporolife. The TRMX 5 50th Anniversary Treatment combined 855 mg of Generation 5th Sporolife with Diamonite, and the other brand had a formulation that contained no Sporolife.

Regular monitoring with incentives and compensation were provided at the final study to ensure 100% participant retention with no drop out.

Data was collected continuously using EEG for six hours after participants applied the article and went to bed. Analysis focused on the day each participant achieved 51% - 80% theta wave activity. If this occurred in the final two minutes on a given day, data from the same two-minute window was used for analysis across the remaining days to ensure consistency.

Data was further analyzed using Pearson Correlation Calculation and Anova Calculation to investigate the relationship of the articles with Rate Score, Mean Score, BMI, weight, height, age, and gender.

Pearson Correlation Formula:

Anova Formula:

RESULTS AND ANALYSIS

MEGA GOLD was the top performer, showing the highest improvement in both Rate Score and Mean Amplitude, indicating an optimal transition to sleep (+58.20% or PLUS 58.20% to sleep performance). The TRMX 5 50th Anniversary also demonstrated solid improvement, ranking second (+41.47% or PLUS 41.47% to sleep performance). In contrast, the Other Brand (No Sporolife) performed the worst, actively reducing theta brainwave activity (-40% or MINUS 40% to sleep performance).

Table 1: Performance Ranking vs No Treatment

Table 2: Most Improved Participant

Table 3: Least Improved Participant

The relationship between Articles (Tested Products such as Placebo Control, Mega Gold, TRMX 5 50th Anniversary, and other brands without Sporolife) and various factors was analyzed using Pearson correlation and ANOVA (see Table 4 and 5). The results showed that while Rate Score (theta brainwave activity) and Mean Amplitude (theta brainwave strength) were significantly affected by the tested products, factors such as age, height, weight, and BMI were not. This indicates that MEGA GOLD and TRMX 5 50th Anniversary can be used safely across individuals of varying ages, heights, weights, and BMI.

Table 4: Articles Relationship Analysis Using Pearson Correlation

Table 5: Articles Relationship Analysis Using Anova

An interesting pattern emerged when examining the relationship between gender and the tested products (see Table 6).

MEGA GOLD showed exceptionally high and optimal results (Rate Score ~77.6%, Amplitude ~47 uV) with minimal difference between genders. In the TRMX 5 50th Anniversary, females performed slightly better than males.

These findings suggest that MEGA GOLD performs well for all genders, while TRMX 5 50th Anniversary may be slightly more effective for females.

For the Placebo Control (Blank), both genders performed poorly, though males had a slight advantage. The Other Brand (No Sporolife) delivered very poor results for both genders, with females marginally outperforming males in Rate Score.

The results also indicate that males may be more responsive to placebo effects, whereas females appear more resilient to sleep disturbances.

Table 6: Articles Relationship With Gender

CONCLUSION AND KEY FINDINGS

The findings of this study highlight the significant impact of tested products on sleep performance. MEGA GOLD emerged as the most effective treatment, demonstrating the highest improvement in both Rate Score and Mean Amplitude, confirming its potential as an optimal solution for enhancing sleep quality. The TRMX 5 50th Anniversary also showed strong results, particularly among females, suggesting it may offer additional benefits for this group.

In contrast, the Other Brand (No Sporolife) not only failed to improve sleep performance but actively reduced theta brainwave activity, indicating a potentially disruptive effect on sleep quality.

The analysis further revealed that factors such as age, height, weight, and BMI had no significant influence on treatment outcomes. This suggests that MEGA GOLD and TRMX 5 50th Anniversary can be safely recommended for individuals across various demographics.

The observed gender differences highlight that males may be more responsive to placebo effects (Fillingim, R. B., et al. (2009). Sex, gender, and pain: A review of recent clinical and experimental findings. PMC.), while females may demonstrate greater resilience to sleep disturbance. The greater resilience to sleep disturbances may be related to certain physiological traits such as higher SWS (Slow-Wave Sleep) and 0.16 more sleep spindles per minutes than males (Krueger, J. M., et al. (2009). Sleep and immune function. Journal of Clinical Sleep Medicine).

These findings provide valuable insights into the effectiveness of tested products in improving sleep quality and may help guide future research and treatment strategies.

APPENDIX: DETAILED PARTICIPANT DATA

This section provides detailed test results for each of the 1,000 participants involved in the study. To ensure easy access and review, the data is presented in a navigable format using buttons that allow users to switch between individual participant records. Each entry includes key metrics such as Rate Score, Mean Amplitude, and corresponding treatment details. This interactive format offers a clear and organized way to examine individual outcomes efficiently.