1.
Effects of the Lysulin™ supplementation on pre-diabetes: A randomized double-blind, placebo-controlled clinical trial.
Ranasinghe, P, Jayawardena, R, Chandrasena, L
Diabetes & metabolic syndrome. 2020;(5):1479-1486
Abstract
BACKGROUND AND AIMS Diabetes is a leading cause of morbidity and mortality worldwide. Recent studies have demonstrated that nutraceutical products have beneficial effects in diabetes. Present study aims to investigate whether a product (Lysulin™) containing amino acid lysine, micronutrient zinc and vitamin C will have beneficial effects in pre-diabetes. METHODS A randomized, double-blind, placebo-controlled trial was conducted for a period of 6 months. The two parallel groups (1:1) were Lysulin™ (Interventional group-IG) and placebo (control group-CG). Evaluations were done at baseline, 1, 3 and 6 months. Primary outcome was defined as change in glycaemic control measured by HbA1c from baseline. Other outcomes included change in; fasting plasma glucose (FPG), 2-h OGTT plasma glucose and lipid profile from baseline. Three multiple regression analyses were performed, where change in FPG, 2-h OGTT, and HbA1c post intervention from baseline respectively were the continuous dependent variable with other independent variables. RESULTS One hundred and ten participants were recruited, 50% (n = 55) were males and mean age (±SD) was 46.7 ± 9.9 years. A significantly higher percentage of participants in CG (25.4%, n = 14) developed diabetes in comparison to IG (7.3%, n = 4) (p = 0.018). FPG, 2-h OGTT and HbA1c significantly reduced in the IG only. Both total cholesterol and LDL cholesterol decreased significantly from baseline only in the IG. In all three regression models the best predictor of respective dependent variable was Lysulin™ treatment. CONCLUSIONS Lysulin™ improved glycaemic control, with reduced progression to diabetes, in those with pre-diabetes. Treatment also showed a beneficial reduction in total and LDL cholesterol levels. TRIAL REGISTRATION Sri Lanka Clinical Trials Registry, identifier: SLCTR/2018/022 (http://slctr.lk/trials/1290). Registered on 13th July 2018; Study protocol version 2.0 (23rd March 2018).
2.
The Effect of Curcumin on Serum Copper and Zinc and Zn/Cu Ratio in Individuals with Metabolic Syndrome: A Double-Blind Clinical Trial.
Safarian, H, Parizadeh, SMR, Saberi-Karimain, M, Darroudi, S, Javandoost, A, Mohammadi, F, Moammeri, M, Ferns, GA, Ghayour-Mobarhan, M, Mohebati, M
Journal of dietary supplements. 2019;(6):625-634
Abstract
Metabolic syndrome is a complex disorder with high socioeconomic costs and a high global prevalence. The serum concentrations of some trace elements are higher in people with metabolic syndrome compared to normal individuals. Curcumin is derived from turmeric and has antioxidant and anti-inflammatory properties. Curcumin may therefore have a potential role in the management of cardiovascular risk. The aim of this study was to investigate the effects of curcumin on serum copper (Cu), zinc (Zn), and Zn/Cu ratio levels in patients with metabolic syndrome. A double-blind clinical trial was designed in which 120 individuals with metabolic syndrome were randomly assigned to one of three groups: curcumin 1gr/day, phospholipidated curcumin 1gr/day, or a placebo, each taken for 6 weeks. Serum copper and zinc were measured before and after intervention. At baseline, in addition to obtaining the anthropometric characteristics of participants, a fasting blood sample was taken from each participant, and the concentrations of serum Cu and Zn were measured by atomic absorption (Varian AA 240 FS model). Serum Zn concentrations rose significantly in the phospholipidated curcumin and curcumin groups, being significantly higher (p <.001) in the phospholipidated curcumin group than in the curcumin group (p <.05). Serum Zn concentration fell in the control group (p <.05). Changes in serum Zn level from baseline to the levels after six weeks' intervention were significantly different between the groups, but changes in serum Cu from between baseline until after intervention were not significantly different. The serum Zn/Cu level in phospholipidated curcumin and curcumin groups after intervention was higher than for the control group, but it was more significant in the group taking phospholipidated curcumin (p <.001). Curcumin and phospholipidated curcumin complex, given at a dose of 1 g per day for six weeks, were associated with an increase in serum zinc and consequently zinc-to-copper ratio.
3.
Zinc supplementation improves anticancer activity of monocytes in type-2 diabetic patients with metabolic syndrome.
Meksawan, K, Sermsri, U, Chanvorachote, P
Anticancer research. 2014;(1):295-9
Abstract
BACKGROUND Transmembrane tumor necrosis factor (TNF)-α, found on monocytes, is a body's key defense against cancer. In patients with type 2 diabetes mellitus (DM) and metabolic syndrome, immunity is suppressed, resulting in a high risk of several inflammatory disorders and cancer. PATIENTS AND METHODS Seventeen patients with type 2 DM and metabolic syndrome were supplemented with either 30 mg of elemental zinc/day or placebo for eight weeks. Transmembrane TNF-α-expressing monocytes and lymphocytes, and plasma TNF-α levels were analyzed before and after supplementation. RESULTS The present study revealed that zinc supplementation significantly increased the proportion of monocytes expressing transmembrane TNF-α. While the plasma TNF-α levels and TNF-α expressing lymphocytes were not significantly altered in the zinc-treated and placebo groups, higher proportion of TNF-α bound monocytes were observed in the zinc-treated group. CONCLUSION Because functional transmembrane TNF-α was shown to be implicated in defense mechanisms, these findings suggest that zinc supplementation may benefit immune response against cancer in patients with DM and metabolic syndrome.