The effects of the fruit on blood glucose levels were assessed in patients
with diabetes (26). Nineteen subjects were enrolled in the study,
including 14 patients with type I or type II diabetes mellitus, and five
healthy volunteers. The preparation used in this investigation was a protein
isolated from the crude drug and termed “vegetable insulin”. The
protein extract was suspended in sterile water and administered subcutaneously
at a concentration of 1.8 mg of protein per 40-unit dose. Nine of
the diabetic patients received 10 units of the formulation if their fasting
blood sugar was less than 180 mg/dl; 20 units when it was 180–250 mg/dl;
and 30 units when it was > 250 mg/dl. Five patients with diabetes and five
healthy volunteers received a placebo (sterile water). The primary endpoint
was a decrease in fasting blood glucose, which was measured over
12 hours after administration. The results showed a mean decrease in serum
glucose levels for the diabetic patients receiving treatment as early as
30 minutes after administration, a 21.5% decrease from mean baseline of
295 mg/dl. After 4 hours, a maximum decrease of 49.2% in serum glucose
was observed, and at 12 hours a 28% drop persisted. In contrast, patients
administered the placebo had a 5% decrease in serum glucose over the
study period. The patients with diabetes who received treatment had substantially
reduced mean baseline serum glucose concentrations, 295 mg/dl
versus a concentration in the placebo group of 210 mg/dl. No blinding,
randomization or statistical analyses were performed (26).