A Double-Blind, Placebo-Controlled Study of Fermented Deglycyrrhizinated Licorice Extract

Diabetes mellitus complications continue to develop despite optimal glycemic control with insulin. Recent studies suggest that serum amylase deficiency correlates with the severity of diabetic complications. This study hypothesizes that α-amylase enzyme deficiency represents an enzymatic defect in the cascade between activated insulin receptors and mitochondrial energy liberation, contributing to diabetic complications.

α-amylase is a glycolytic enzyme that undergoes entero-pancreatic circulation and is proposed to be a precursor to key phosphorylating enzymes (glycogen phosphorylase, glucokinase, and hexokinase) essential for glycolysis. Supplementation with α-amylase may restore normal carbohydrate metabolism and prevent diabetic complications.

The study drug is a formulation rich in α-amylase enzyme prepared from fermented deglycyrrhizinated licorice root extract, also containing acid-lipase enzyme and naturally occurring flavonoids. The intervention was administered as 500mg capsules twice daily, one hour before meals, for 6 months alongside regular antidiabetic medications.

Inclusion criteria

• Confirmed diagnosis of Type 1 or Type 2 diabetes mellitus
• Age between 15 and 65 years
• Diabetes duration of 1-5 years
• Body Mass Index (BMI) < 30 kg/m²
• HbA1c < 9%
• Serum creatinine < 2mg/dL
• Serum α-amylase < 45 IU/L (reference range: 28-100 IU/L)
• Vibration Perception Threshold (VPT) > 15V
• Absence of clinical symptoms of diabetic polyneuropathy

Exclusion criteria

• Treatment with medications that might influence nerve function (antiepileptic agents, tricyclic antidepressants, sympathomimetic agents)
• Presence of myopathies
• Presence of neuropathies from other causes
• Presence of malignancies
• Clinical symptoms of diabetic polyneuropathy
• Inability to comply with study protocol