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
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 |
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 |
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 |
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 |
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 |
(-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 |
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 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 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 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.