Diabetes mellitus is a leading cause of morbidity and mortality worldwide. Recent studies have demonstrated that nutraceutical products have beneficial effects in diabetes.
The present study, by researchers at the University of Colombo, in Sri Lanka, and Queensland University of Technology, in Australia, aimed to investigate whether Lysulin - containing amino acid Lysine, Zinc and Vitamin C - would have beneficial effects on glycaemic control and disease progression in pre-diabetes.
A randomised, double-blind, placebo-controlled clinical trial was conducted for a period of 6 months. 110 subjects (aged 46.7±9.9 years) with pre-diabetes were recruited and randomised into two parallel groups - Lysulin and placebo - and evaluations were done at baseline, 1, 3 and 6 months.
The results revealed that Lysulin supplementation significantly improved beta cell function (which produce and release insulin and amylin) and insulin resistance. It also significantly reduced conversion from prediabetes to type 2 diabetes, blood levels of HbA1c (a form of hemoglobin chemically linked to a sugar), fasting blood glucose, and oral glucose tolerance tests.
During the 6-month follow-up period a significantly higher percentage of participants in Placebo group developed type 2 diabetes in comparison to Lysulin group. FPG, 2-hour OGTT and HbA1c significantly reduced in the Lysulin group only.
Observed HbA1c reduction during 6-month follow-up period in Lysulin group is 0.5%. Both total cholesterol and LDL cholesterol decreased significantly from baseline only in the Lysulin group. In all three regression models the best predictor of respective dependent variable was Lysulin treatment.
Lysulin improved glycaemic control, with reduced progression to diabetes, in those with pre-diabetes. The treatment also showed a beneficial reduction in total and LDL cholesterol levels. Further studies are required to fully elucidate the mechanisms responsible.
Lysine is an essential amino acid that plays a major role in calcium absorption and has been shown to have numerous beneficial effects in the treatment of diabetes and/or it’s complications in in-vivo animal and human studies.
Lysine is known to react with glucose with the glycated amino acid being excreted in urine and it has been shown to markedly attenuate the glucose response to ingested glucose without a change in insulin response in humans.
Furthermore, studies have shown that it reduces the formation of glycated proteins in diabetes induced animal models.
Zinc is involved in numerous metabolic pathways as a co-factor for more than 300 enzymes. Insulin, which contains a variable number of Zinc atoms, isstored in β-cells of the pancreas and released into the portal venous system at the time of β-cells de-granulation.
Zinc plays an important role for insulin action, carbohydrate and protein metabolism. It has been long known that diabetes is accompanied by hypozincemia and hyperzincuria. A recently concluded clinical trial on patients with pre-diabetes demonstrated that Zinc supplementation helps to reduce blood glucose and insulin resistance, while improving β-cell function.
Furthermore, disease progression to diabetes was also reduced and beneficial effects of supplementation were also noted on total and LDL cholesterol.
Vitamin C is structurally similar to glucose and can replace it in many chemical reactions and thus is effective for prevention of nonenzymatic glycosylation of protein. Randomised controlled trials have shown that supplementation of Vitamin C reduces blood glucose, serum lipids and improves HbA1c in type 2 diabetes.
Lysulin’s approved patents include the prevention of protein glycation using Lysine supplements for a method of monitoring blood sugar control and as a method of treating diabetes using a supplement.
Source: Journal of Diabetes Research
Ranasinghe. P., et al
"Effects of the Lysulin supplementation on pre-diabetes: A randomized double-blind, placebo-controlled clinical trial"