Fariba Raygan1, Vahidreza Ostadmohammadi2, Fereshteh Bahmani3, Zatollah Asemi4. 1. Department of Cardiology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran. 2. Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran; Student Research Committee, Kashan University of Medical Sciences, Kashan, Iran. 3. Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran. 4. Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran. Electronic address: asemi_z@Kaums.ac.ir.
Abstract
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 8 × 109 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 μIU/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 μmol/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, plasmaNO, TAC, glycemic control and HDL-cholesterol levels. CLINICAL TRIAL REGISTRATION NUMBER: http://www.irct.ir: IRCT2017073033941N4.
RCT Entities:
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 8 × 109 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 μIU/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 μmol/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. CLINICAL TRIAL REGISTRATION NUMBER: http://www.irct.ir: IRCT2017073033941N4.
Authors: Thomaz F S Bastiaanssen; Sofia Cussotto; Marcus J Claesson; Gerard Clarke; Timothy G Dinan; John F Cryan Journal: Harv Rev Psychiatry Date: 2020 Jan/Feb Impact factor: 3.732