Metabolic benefits of probiotic combination with absorbent smectite in type 2 diabetes patients: a randomised controlled trial

Background: Numerous non-drug therapies have emerged in recent years for the prevention and improvement of type 2 diabetes (T2D). However, therapies based on dietary modification and/or microbiota may replace a large part of drug therapies in the coming years. The current study aim was to conduct placebo-controlled randomize clinical trial for the efficiency of a combination of multiprobiotics with smectite absorbent gel (Symbiter-Forte formulation) as an adjunction to the standard anti-diabetic therapy. Methods: A total of 55 patients met the criteria and were included in double-blind single center RCT, to receive “Symbiter-Smectite” or placebo for 8-weeks administered as a sachet formulation. The primary main outcome was the change HOMA2-IR and insulin sensitivity (% S). Secondary outcomes were glycemic control parameters, β-cells functional activity, anthropometric parameters and markers of a chronic systemic inflammatory response. Results: Combined use of the probiotic mixture with smectite leads to a significant reduction of HOMA2-IR (3.14±0.97 vs 2.79±0.85; р=0.009) and improvement of % S (34.65±9.92 vs 39.42±12.78; p=0.011) after 8 weeks of treatment period. Simultaneously in secondary outcome analysis were detected lowering of HbA1c, waist circumference but not BMI and pro-inflammatory cytokines IL-1β (p=0.004), TNF-α (p=0.008), IL-6 (p=0.005) and IL-8 (p=0.042). In placebo group changes were insignificant. Conclusion: Probiotic with smectite due to his absorbent activity and stabilization mucus layer properties can impact on synergistic enhancement of single effect which manifested with significant reduction of IR, waist circumference, markers of chronic systemic inflammation and improvement of glycemic profile as compared to placebo.

Download Full-text

The effect of menaquinone-7 supplementation on vascular calcification in patients with diabetes: a randomized, double-blind, placebo-controlled trial

American Journal of Clinical Nutrition ◽

10.1093/ajcn/nqz147 ◽

2019 ◽

Vol 110 (4) ◽

pp. 883-890 ◽

Cited By ~ 18

Author(s):

S R Zwakenberg ◽

P A de Jong ◽

J W Bartstra ◽

R van Asperen ◽

J Westerink ◽

...

Keyword(s):

Type 2 Diabetes ◽

Vascular Calcification ◽

Vitamin K ◽

Controlled Trial ◽

Matrix Gla Protein ◽

Arterial Calcification ◽

Secondary Outcome ◽

Double Blind

ABSTRACT Background Vitamin K occurs in the diet as phylloquinone and menaquinones. Observational studies have shown that both phylloquinone and menaquinone intake might reduce cardiovascular disease (CVD) risk. However, the effect of vitamin K on vascular calcification is unknown. Objectives The aim of this study was to assess if menaquinone supplementation, compared to placebo, decreases vascular calcification in people with type 2 diabetes and known CVD. Methods In this double-blind, randomized, placebo-controlled trial, we randomly assigned men and women with type 2 diabetes and CVD to 360 µg/d menaquinone-7 (MK-7) or placebo for 6 mo. Femoral arterial calcification at baseline and 6 mo was measured with 18sodium fluoride positron emission tomography (18F-NaF PET) scans as target-to-background ratios (TBRs), a promising technique to detect active calcification. Calcification mass on conventional computed tomography (CT) scan was measured as secondary outcome. Dephosphorylated–uncarboxylated matrix Gla protein (dp-ucMGP) concentrations were measured to assess compliance. Linear regression analyses were performed with either TBR or CT calcification at follow-up as the dependent variable, and treatment and baseline TBR or CT calcification as independent variables. Results We randomly assigned 35 patients to the MK-7 group (33 completed follow-up) and 33 to the placebo group (27 completed follow-up). After the 6-mo intervention, TBR tended to increase in the MK-7 group compared with placebo (0.25; 95% CI: −0.02, 0.51; P = 0.06), although this was not significant. Log-transformed CT calcification mass did not increase in the intervention group compared with placebo (0.50; 95% CI: −0.23, 1.36; P = 0.18). MK-7 supplementation significantly reduced dp-ucMGP compared with placebo (−205.6 pmol/L; 95% CI: −255.8, −155.3 pmol/L). No adverse events were reported. Conclusion MK-7 supplementation tended to increase active calcification measured with 18F-NaF PET activity compared with placebo, but no effect was found on conventional CT. Additional research investigating the interpretation of 18F-NaF PET activity is necessary. This trial was registered at clinicaltrials.gov as NCT02839044.

Download Full-text