Table 3

Primary efficacy variables after randomization and after 8 weeks of intervention
Intervention OPLE-500 OPLE-1000 FICUS
Fasting Plasma Glucose (mg/dL)
*Initial 106±11 103±10 104±14
Final 99±10 98±8 106±16
Change −7.7±7 −5±7 −1±8
p value for change p=0.02 p=0.06 p=0.61
Fasting Plasma Insulin (U/ml)
*Initial 14.4±11.2 8.0±4.3 13.1±5.4
Final 9.1±5.8 8.6±6.1 11.0±6.0
Change −5.4±7.2 0.6±4.2 −2.1±8.1
p value for change p=0.04 p=0.96 p=0.14
Insulin Sensitivity (%)
Initial 91 (75) 137 (122) 77 (72)
Final 172 (123) 136 (119) 114 (93)
%Change 87±113 7±41 91±25
p value for change p=0.03 p=0.92 p=0.57
Insulin Resistance
Initial 1.66 (1.34) 0.93 (0.83) 1.50 (1.40)
Final 1.04 (0.82) 0.98 (0.84) 1.27 (1.07)
% Change −31%±36 −14%±72 −8%±42
p value for change p=0.055 p=0.92 p=0.65

*Initial values from the baseline OGTT pre-dose sample at the time of randomization to study. Values are given as the mean ± SD.

Final values from the baseline OGTT pre-dose sample after 8 weeks of intervention. Values are given as the mean ± SD.

Values are given as the mean (geometric mean).

For each continuous variable at each time point, the mean differences in the variable or in the change in that variable from baseline between the different products was tested for nominal significance by the one-way analysis of variance (ANOVA) or by the non-parametric Kruskal-Wallis test if non-normally distributed. This applied to all of the insulin calculations.

Kalman et al.

Kalman et al. Nutrition Journal 2013 12:36   doi:10.1186/1475-2891-12-36

Open Data