Hempzorb81 – Immunity Response

Technical Memo

TO:Matt Smith- Med7, lie

FROM: SHAUNNA K. BURBIDGE, PHD

PROJECT: STATISTICAL ANALYSIS OF IMMUNE RESPONSE TO HEMPZORB 81 (MED7) BY DOSAGE

DATE: DECEMBER 27, 2021


Summary Statistics

Before a full statistical panel could be run and evaluated, a baseline evaluation was established. All 83 subjects included in this analysis tested positive for SARS Cov 2 (Covid-19). Tables 1-3 below show the summary statistics for immune response markers in the Hempzor 81 and placebo groups.
Table 1. Summary Statistics-Placebo Group
  Week 1 Week 2 Week 4
Min Max Mean Min Max Mean Min Max Mean
TNF 0.43 3.50 1.43 0.08 4.50 1.64 0.06 6.00 1.93
CRP 4 22 11.07 1.50 24.0 10.94 2.40 19.0 11.38
IL-1 4.60 15.50 8.56 4.50 23.00 9.14 5.40 22.0 9.01
IL-6 0.70 4.50 2.61 0.80 8.00 2.88 0.90 10.0 2.82
Homocysteine 15 147 54.86 7 153 40.33 8 170 27.67
White Blood Count 500 6,000 3,246 650 5,800 3,521 2,000 7,500 4,017
                  N=44
Table 2. Summary Statistics-Med 7 (3ml)
  Week 1 Week 2 Week 4
Min Max Mean Min Max Mean Min Max Mean
TNF 0.30 3.40 1.55 0.50 3.20 1.48 0.70 2.40 1.35
CRP 5.00 36.00 12.51 0.40 6.00 3.41 0.30 4.60 2.78
IL-1 3.20 8.10 5.79 1.70 6.80 5.59 2.50 6.80 5.69
IL-6 0.90 9.20 2.37 0.80 5.50 2.11 0.80 2.40 1.65
Homocysteine 11 55 36.67 10 56 33.21 10 55 24.77
White Blood Count 4300 125,000 22,228 5,500 95,000 12,466 1,000 85,000 9,846
                  N=39
Table 3. Summary Statistics- Entire Sample
  Week 1 Week 2 Week 4
Min Max Mean Min Max Mean Min Max Mean
TNF 0.30 3.50 1.49 0.08 4.50 1.57 0.06 6 1.65
CRP 4 36 11.76 0.40 24.0 7.36 0.30 19 7.29
IL-1 3.20 15.50 7.24 1.70 23 7.45 2.50 22 7.44
IL-6 0.70 9.20 2.49 0.80 8.0 2.52 0.80 10 2.26
Homocysteine 11 147 46.21 7 153 36.94 8 170 26.29
White Blood Count 500 125,000 12,274 650 95,000 7,775 1000 85,000 6,790
                  N=83

2.0 Statistical Analysis

This section utilizes statistical mean comparison (paired sampled and independent samples t-test) to evaluate the impact that the Hempzorb 81 product has on study participant immune response among patients diagnosed with SARS Covid 2 when compared to placebo. Outcomes analyzed include TNF, CRP, IL-1, IL-6, Homocysteine, and WBC.

Tumor Necrosis Factor (TNFJ

Tumor Necrosis Factor (TNF) is anti-inflammatory cytokine produced by microphages/monocytes during periods of acute inflammation. Higher levels of TNF indicate disease, such as arthritis, diabetes, Crohn's and even cancer. The normal range for TNF is 0.75 ± 0.15 pg/ml. Table 4 shows the distribution of change in TNF over the 4-week study period for each of the three dosage groups.
Table 4. TNF Levels over Study Period: by dose
TNF Week 1 Week 2 Week 4
Placebo= 0ml 1.43 1.64 1.93
3ml 1.82 1.66 1.43
4ml 1.16 1.21 1.23
      N=83
A paired samples t-test was employed to identify any significant changes in TNF over the course of the study (4 weeks). The analysis found that there was a significant difference in the change in TNF between the placebo group and the Hempzorb 81 group during the study period. Those taking Hempzorb 81 saw a significant reduction in TNF over the 4 weeks of the study compared to the placebo group.

Table 5. Paired Samples t-Test: TNF Change Weeks 1-4

  95% Confidence Interval  
Hempzorb 81 Dose Mean Change Lower Upper t p
Weeks 1-2 0ml 0.22 -0.035 0.623 1.775 0.040
3-4ml -0.07
Weeks 2-4 0ml 0.28 0.136 0.678 2.99 0.002
3-4ml -0.13
Weeks 1-4 0ml 0.49 0.326 1.075 3.721 <0.001
3-4ml -0.20
            N=83

C-Reactive Protein

(-reactive protein (CRP) is made by the liver and levels increase when there is inflammation somewhere in the body. It is often used to monito the severity of disease in chronic conditions. The normal range for CRP is between 0.3-5.0 mg/ml. Table 6 shows the average change in (-Reactive Protein (CRP) over the 4-week study period for each of the dosage groups.

Table 6. C-Reactive Protein over Study Period: by dose

CRP Week 1 Week2 Week4
Placebo= 0ml 11.069 10.942 11.381
3ml 13.300 2.965 2.615
4ml 12.000 3.831 2.975
      N=83

A paired samples t-test was employed to identify any significant changes inc-reactive protein over the course of the study (4 weeks). The analysis determined there is a significant difference in the change in c-reactive protein between the placebo group and the Hempzorb 81 group during the study period. Participants taking 3-4ml per day of Hempzorb 81 saw a significant reduction in their c-reactive protein when compared to the placebo group.

Table 7. Paired Samples t-Test: C-Reactive Protein Weeks 1-4

  95% Confidence Interval  
Hempzorb 81 Dose Mean Change Lower Upper t p
Weeks 1-2 0ml -0.13 6.941 11.01 8.775 <0.001
3-4ml -9.11
Weeks 2-4 0ml 0.44 0.106 2.029 2.210 0.015
3-4ml -0.63
Weeks 1-4 0ml 0.31 7.864 12.226 9.167 <0.001
3-4ml -9.73
            N=83

lnterleukin-1 Beta

lnterluekin 1 13 (IL-1) is a pro-inflammatory cytokine associated with insulin secretion, appetite regulation and fever reduction. It is known to be a better measure associated with severity of simple steatosis (fatty liver) than liver function tests in obese patients. Table 8 below shows the blood levels of IL-1 among study participants. Normal range for IL-1 range from 0.5 to 5 pg/ml.

Table 8. Change in IL-1 over Study Period: by dose

IL-1 Week 1 Week2 Week4
Placebo= 0ml 8.558 9.142 9.016
3ml 6.200 5.785 6.025
4ml 5.343 5.300 5.281
      N=83

A paired samples t-test was employed to identify any significant changes in lnterluekin 1 13 (IL-1) over the course of the study (4 weeks). The analysis determined there was no significant difference in the change in IL-1 between the placebo group and the Hempzorb 81 group during the study period.

Table 3. Paired Samples t-Test: IL-1 Weeks 1-4

  95% Confidence Interval  
Hempzorb 81 Dose Mean Change Lower Upper t p
Weeks 1-2 0ml 0.584 0.034 1.538 2.080 0.020
3-4ml -0.203
Weeks 2-4 0ml -0.125 -1.219 0.762 -0.458 0.324
3-4ml 0.103
Weeks 1-4 0ml 0.458 -0.486 1.063 1.063 0.145
3-4ml -0.100
            N=83

Interleukin 6

Interleukin 6 is a cytokine that induces synthesis of acute phase proteins like CRP and inhibits the production of albumin. High levels have been shown to predict the need for mechanical ventilation and extensive lung damage among SARS Covid 2 patients. Normal range for IL-6 is less than 1.8 ml.

Table 10. Change in IL-1 over Study Period: by dose

IL-6 Week 1 Week2 Week4
Placebo= 0ml 2.609 2.888 2.816
3ml 2.835 2.495 1.740
4ml 1.844 1.669 1.569
      N=83

A paired samples t-test was employed to identify any significant changes in IL-6 over the course of the study (4 weeks). The analysis determined there is a significant difference in the change in IL-6 between the placebo group and the Hempzorb 81 group during the study period. Participants taking 3-4ml per day of Hempzorb 81 saw a significant reduction in their IL-6 when compared to the placebo group.

Table 11. Paired Samples t-Test: IL-6 Weeks 1-4

  95% Confidence Interval  
Hempzorb 81 Dose Mean Change Lower Upper t p
Weeks 1-2 0ml 0.279 0.089 0.992 2.386 0.010
3-4ml -0.262
Weeks 2-4 0ml -0.072 -0.095 0.859 1.592 0.058
3-4ml -0.454
Weeks 1-4 0ml 0.207 0.276 1.569 2.842 0.003
3-4ml -0.715
            N=83

Homocysteine

Homocysteine is an amino acid. High levels can indicate a B vitamin deficiency and can result in damage to the lining of the arteries. It is often used as an inflammatory risk for cardiovascular risk and can elevate with stress. A normal homocysteine range is 5-15 mcmol/L.

Table 12. Change in Homocysteine over Study Period: by dose

Homo Week 1 Week2 Week4
Placebo= 0ml 54.860 40.326 27.674
3ml 40.150 38.800 28.700
4ml 30.562 25.125 18.562
      N=83

A paired samples t-test was employed to identify any significant changes in homocysteine levels over the course of the study (4 weeks). The analysis determined there is a significant difference in the change in Homocysteine levels between the placebo group and the Hempzorb 81 group during the study period. Participants in the placebo group experienced a significantly larger drop in their homocysteine levels compared to those taking 3- 4ml per day of Hempzorb 81.

Table 13. Paired Samples t-Test: Homocysteine Weeks1-4

  95% Confidence Interval  
Hempzorb 81 Dose Mean Change Lower Upper t p
Weeks 1-2 0ml -14.535 -21.731 -0.416 -2.068 0.021
3-4ml -3.462
Weeks 2-4 0ml -12.651 -9.901 1.471 -1.475 0.072
3-4ml -8.436
Weeks 1-4 0ml -27.186 -25.207 -5.370 -3.067 0.001
3-4ml -11.897
            N=83

White Blood Count

White blood count WBC) measures the number of white blood cells or leukocytes in the blood. If the volume is too low, it can indicate that an individual may have a hard time fighting off an infection. The normal white blood cell count in a healthy adult is between 4,000 and 11,000 WBCs per microliter.

Table 10. Change in WBC over Study Period: by dose

WBC Week 1 Week2 Week4
Placebo= 0ml 3,246 3,520 4,017
3ml 19,750 8,462 7,705
4ml 27,618 18,003 7,868
      N=83

A paired samples t-test was employed to identify any significant changes in WBC levels over the course of the study (4 weeks). The analysis determined there is a significant difference in the change in WBC between the

placebo group and the Hempzorb 81 group during the study period. Participants in the placebo group experienced a significantly larger drop in their homocysteine levels compared to those taking 3-4ml per day of Hempzorb 81.

Table 11. Paired Samples t-Test: WBC Weeks1-4

  95% Confidence Interval  
Hempzorb 81 Dose Mean Change Lower Upper t p
Weeks 1-2 0ml 274.42 -1,667.8 2,1739.7 1.706 0.046
3-4ml -9,761.5
Weeks 2-4 0ml 496.51 -3,033.7 9,267.8 1.009 0.158
3-4ml -2,620.5
Weeks 1-4 0ml 770.93 2,088.6 24,217.3 2.336 0.010
3-4ml -12,382
            N=83

3.0 Conclusions

Participants receiving Hempzorb 81 experienced significant changes in their immune response over the 4- week study period. Participants in the placebo (non-experimental) group saw a significant improvement in their homocysteine levels over the 4-week study compared to the Hempzorb 81 recipients, but no significant changes among other immune health metrics. Overall participants taking 3-4ml pf Hempzorb 81 per day saw significant decreases in nearly all immune response markers over the 4 weeks of the study when compared to placebo.

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