The effects of vitamin D and probiotic co-supplementation on mental health parameters and metabolic status in type 2 diabetic patients with coronary heart disease: A randomized, double-blind, placebo-controlled trial

Background: This study was carried out to evaluate the effects of vitamin D and probiotic co-supplementation on mental health parameters and metabolic status in diabetic people with coronary heart disease (CHD). Methods: This randomized, double-blind, placebo-controlled trial was carried out among 60 diabetic people with CHD, aged 45-85 years old. Subjects were randomly allocated into two groups to receive either 50,000 IU vitamin D every 2 weeks plus 8x10(9) CFU/g probiotic of Lactocare Zisttakhmir Co (n = 30) or placebo (n = 30) for 12 weeks. Fasting blood samples were obtained at baseline and after the 12-week intervention to determine metabolic profiles. Results: After the 12-week intervention, compared with the placebo, vitamin D and probiotic co-supplementation resulted in significant improvements in beck depression inventory total score (-2.8 +/- 3.8 vs. -0.9 +/- 2.1, P = 0.01), beck anxiety inventory scores (-2.1 +/- 2.3 vs. -0.8 +/- 1.4, P = 0.009) and general health questionnaire scores (-3.9 +/- 4.1 vs. -1.1 +/- 3.4, P = 0.005). Compared with the placebo, vitamin D and probiotic co-supplementation resulted in significant reductions in serum insulin levels (-2.8 +/- 3.8 vs. + 0.2 +/- 4.9 mu IU/mL, P = 0.009), homeostasis model of assessment-estimated insulin resistance (-1.0 +/- 1.6 vs. -0.1 +/- 1.5, P = 0.02), and a significant increase in serum 25-OH-vitamin D (+ 11.8 +/- 5.9 vs. + 0.1 +/- 1.4 ng/mL, P < 0.001), the quantitative insulin sensitivity check index (+ 0.03 +/- 0.04 vs. -0.001 +/- 0.01, P = 0.003) and serum HDL-cholesterol levels (+ 2.3 +/- 3.5 vs. -0.5 +/- 3.8 mg/dL, P = 0.004). In addition, changes in serum high sensitivity C-reactive protein (hs-CRP) (-950.0 +/- 1811.2 vs. + 260.5 +/- 2298.2 ng/mL, P = 0.02), plasma nitric oxide (NO) (+ 1.7 +/- 4.0 vs. -1.4 +/- 6.7 mu mol/L, P = 0.03) and plasma total antioxidant capacity (TAC) (+ 12.6 +/- 41.6 vs. -116.9 +/- 324.2 mmol/L, P = 0.03) in the supplemented group were significantly different from the changes in these indicators in the placebo group. Conclusions: Overall, vitamin D and probiotic co-supplementation after 12 weeks among diabetic people with CHD had beneficial effects on mental health parameters, serum hs-CRP, plasma NO, TAC, glycemic control and HDL-cholesterol levels.