Info

aSerum VA (jg/l)

250 ± 6.0

230 ± 8.3

250 ± 9.9

300 ±11*

290 ± 13

aaSerum VE (mg/l)

14.5 ± 1.2

13.6 ± 0.6

13.8 ± 0.6

14.7 ± 1.0

15.7 ± 0.7

aSerum Fe (jg/dl)

321 ± 14

309 ± 18

344 ± 24

337 ± 23

344 ± 27

aSerum Zn (mg/l)

1.05 ± 0.03

1.11 ± 0.03

1.16 ± 0.04

1.11 ± 0.04

1.11 ± 0.06

^Hepatic VA (jg/g)

60 ± 3.9

61 ± 4.6

62 ± 4.7

51 ± 5.1

54 ± 5.7

^Hepatic VE (jg/g)

482 ± 14

471 ± 1.7

469 ± 13

469 ± 16

481 ± 42

aData are reported as mean values (± SEM).

bData represent mean values (± SEM) of three randomly selected liver samples per treatment/sex . 'Indicates statistical difference compared to controls (p < 0.05).

aData are reported as mean values (± SEM).

bData represent mean values (± SEM) of three randomly selected liver samples per treatment/sex . 'Indicates statistical difference compared to controls (p < 0.05).

Short-term human studies with NovaSil™

A two-week short-term safety evaluation of NovaSil™ was conducted with healthy human volunteers (Wang et al., 2005). This phase I clinical study was designed to determine short-term safety and tolerance of NovaSil™ in normal human subjects. The NovaSil™ was sterilized at 121°C and packaged into capsules. The NovaSil™ capsules were produced under sterile conditions according to U.S. Good Manufacturing Practices.

The overall design of the human study followed the guidelines for a randomized, doubleblind phase I clinical trial. Fifty adults who met the recruiting standards were voluntarily enrolled in the study and divided into two groups. The low-dose group took three capsules of NovaSil™ (0.5 g) three times a day for two weeks. The high-dose group took three capsules of NovaSil™ (1.0 g) three times a day for two weeks. All capsules were the same color and size. The two dose levels were extrapolated from dosimetry data based on animal studies (Phillips, 1999; Phillips et al., 2002; Afriyie-Gyawu et al., 2005). This dosimetry protocol seems suitable for future long-term human intervention studies in larger populations.

Both doses of NovaSil™ used in this study were tolerated by all study participants. Gastrointestinal adverse effects were noticed in 6/25 subjects, in the 1.5 g/day group and by 7/25 subjects in the 3.0 g/day group. Symptoms included bloating, constipation, diarrhea, flatulence, and abdominal discomfort. Two participants in the 1.5 g/day group reported some dizziness, an effect that was not seen in the 3.0 g/day group. All symptoms described were recorded within the first two days after taking the NovaSil™ capsules and no symp-

Table 2. Analysis of minerals and vitamins in serum obtained from human subjects following ingestion of NovaSil™ for 14 days; after Wang et al. (2005).

Mineral or Vitamin

Group

Table 2. Analysis of minerals and vitamins in serum obtained from human subjects following ingestion of NovaSil™ for 14 days; after Wang et al. (2005).

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