Table 5.
Effect on laboratory efficacy variables
| Fasting Blood Sugar [Mean ± SD (CI)] | ||||
|---|---|---|---|---|
| Day 0 | Day 90 | Day 180 | P values | |
| Treatment Group (n = 30) | 121.37 ± 13.13 (116.47–126.28) | 115.22 ± 12.03 (110.73-119.71)∗∗ | 109.88 ± 12.06 (105.34-114.34) ∗∗∗,@@@ | 0.001, 0.0001 |
| Placebo Group (n = 28) | 116.74 ± 6.29 (115.90–127.80) | 121.34 ± 12.32(116.56-126.11)∗ | 123.83 ± 11.24 (119.47-128.19)∗∗ | 0.05,0.001 |
| Post 2 h OGTT Blood Sugar [Mean ± SD (CI)] | ||||
| Day 0 | Day 90 | Day 180 | ||
| Treatment Group (n = 30) | 164.82 ± 41.96 | 163.04 ± 43.89 | 150.12 ± 31.87 | 0.04 |
| (149.15–180.48) | (146.66–179.42) | (138.22–162.01)∗ | 0.13 | |
| Placebo Group (n = 28) | 159.69 ± 19.51 | 157.33 ± 20.87 | 161.39 ± 23.0 | 0.43 |
| (152.12–167.26) | (149.24–165.42) | (152.47–170.31) | ||
| Fasting Insulin [Mean ± SD (CI)] | ||||
| Day 0 | Day 180 | |||
| Treatment Group (n = 30) | 18.38 ± 8.38 (15.25–21.51) | 14.09 ± 6.77 (11.57–16.62)###, @@ | 0.005 | 0.01 |
| Placebo Group (n = 28) | 15.11 ± 3.77 (13.64–16.56) | 17.42 ± 3.99 (15.88–18.97)### | 0.0002 | |
| Post 2 h OGTT Insulin [Mean ± SD (CI)] | ||||
| Treatment Group (n = 30) | 45.96 ± 18.29 (39.13–52.78) | 35.75 ± 19.15 (28.6–42.9)### | 0.0008 | 0.25 |
| Placebo Group (n = 28) | 41.14 ± 12.51 (36.28–45.98) | 40.72 ± 12.66 (35.81–45.63) | 0.88 | |
| HOMA-IR [Mean ± SD (CI)] | ||||
| Treatment Group (n = 30) | 5.70 ± 3.06 (4.56–6.85) | 3.88 ± 2.06 (3.11–4.65)###,@@ | 0.009 | |
| 0.003 | ||||
| Placebo Group (n = 28) | 4.38 ± 1.24 (3.90–4.87) | 5.39 ± 1.56 (4.78–5.99)# | 0.01 | |
| HbA1c [Mean ± SD (CI)] | ||||
| Treatment Group (n = 30) | 6.14 ± 0.37 (5.99–6.27) | 6.10 ± 0.35 (5.96–6.22)# | 0.04 | |
| 0.5 | ||||
| Placebo Group (n = 28) | 6.11 ± 0.23 (6.02–6.20) | 6.15 ± 0.29 (6.04–6.27) | 0.12 | |
| Total Cholesterol [Mean ± SD (CI)] | ||||
| Treatment Group (n = 30) | 176.65 ± 34.65 (163.72–189.59) | 165.95 ± 28.16 (155.44–176.46) | 0.194 | |
| Placebo Group (n = 28) | 191.61 ± 30.54 (179.77–203.45) | 190.23 ± 25.52 (180.33–200.12) | 0.855 | |
| Triglycerides [Mean ± SD (CI)] | ||||
| Treatment Group (n = 30) | 128.62 ± 60.24 (106.13–151.12) | 119.23 ± 54.54 (98.87–139.59) | 0.529 | |
| Placebo Group (n = 28) | 132.78 ± 30.39 (121–144.56) | 133.31 ± 28.01 (122.44–144.17) | 0.946 | |
| HDL Cholesterol [Mean ± SD (CI)] | ||||
| Treatment Group (n = 30) | 42.81 ± 8.56 (39.61–46.01) | 46.09 ± 7.79 (43.19–49) | 0.126 | |
| Placebo Group (n = 28) | 41.08 ± 8.08 (37.95–44.21) | 42.16 ± 7.73 (39.16–45.16) | 0.612 | |
| LDL Cholesterol [Mean ± SD (CI)] | ||||
| Treatment Group (n = 30) | 118.43 ± 27.56 (108.14–128.72) | 113.10 ± 26.94 (103.04–123.16) | 0.452 | |
| Placebo Group (n = 28) | 121.66 ± 24.41 (112.19–131.12) | 122.19 ± 21.47 (113.57–130.52) | 0.931 | |
| VLDL Cholesterol [Mean ± SD (CI)] | ||||
| Treatment Group (n = 30) | 25.73 ± 12.05 (21.23–30.22) | 23.85 ± 10.91 (19.77–27.92) | 0.529 | |
| Placebo Group (n = 28) | 26.56 ± 6.08 (24.20–28.91) | 26.66 ± 5.60 (24.49–28.83) | 0.946 | |
| Oxidative stress marker – MDA [Mean ± SD (CI)] | ||||
| Treatment Group (n = 30) | 3.81 ± 1.08 (3.41–4.22) | 2.4 ± 1.05 (2.01–2.79)###,@@@ | 0.0001 | |
| 0.0001 | ||||
| Placebo Group (n = 28) | 3.85 ± 1.49 (3.27–4.42) | 3.77 ± 1.18 (3.31–4.23) | 0.66 | |
| Oxidative stress marker – SOD [Mean ± SD (CI)] | ||||
| Treatment Group (n = 30) | 0.95 ± 0.45 (0.79–1.12) | 2.31 ± 1.12 (1.89–2.73)###,@@@ | 0.0001, 0.0001 | |
| Placebo Group (n = 28) | 0.91 ± 0.43 (0.74–1.08) | 1.11 ± 0.52 (0.91–1.32)## | 0.001 | |
| C-reactive protein (CRP) [Mean ± SD (CI)] | ||||
| Treatment Group (n = 30) | 3.79 ± 3.27 (2.57–5.01) | 3.35 ± 3.16 (2.18–4.53)#,@@ | 0.08 | |
| 0.003 | ||||
| Placebo Group (n = 28) | 5.33 ± 2.72 (4.28–6.39) | 5.29 ± 3.15 (4.07–6.52) | 0.86 | |
Results are expressed as Mean ± SD (95% Confidence Interval).
∗p < 0.05, ∗∗p < 0.01 & ∗∗∗p < 0.001 as compared to Day 0 using Repeated Measures Analysis of Variance with Tukey–Kramer Multiple Comparisons test.
#p < 0.05, ##p < 0.01 & ###p < 0.001 as compared to Day 0 using paired Student's ‘t’ test in case of parametric data or Wilcoxon matched-pairs signed-ranks test in case of non-parametric data.
@p < 0.05, @@ p < 0.01 & @@@p < 0.001 as compared to Placebo Group using unpaired Student's ‘t’ test in case of parametric data or Mann–Whitney test in case of non-parametric data.