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Table 3 Primary efficacy variables after randomization and after 8 weeks of intervention

From: Efficacy and safety of Elaeis guineensis and Ficus deltoidea leaf extracts in adults with pre-diabetes

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

  1. *Initial values from the baseline OGTT pre-dose sample at the time of randomization to study. Values are given as the mean ± SD.
  2. Final values from the baseline OGTT pre-dose sample after 8 weeks of intervention. Values are given as the mean ± SD.
  3. Values are given as the mean (geometric mean).
  4. 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.