Effect of microbial cell preparation on renal profile and liver function among type 2 diabetics: a randomized controlled trial

Background: The beneficial effect of probiotics on renal profile and liver function has been reported among patients with chronic kidney disease and fatty liver respectively. However, its effect on renal profile and liver function among type 2 diabetic individuals has not been fully understood. To investigate the effect of microbial cell preparation on renal profile and liver function tests among type 2 diabetic individuals. Methods: A randomized, double-blind, parallel-group, controlled clinical trial was conducted on a total of 136 type 2 diabetics age 30-70 years old in a teaching hospital in Kuala Lumpur, Malaysia. Subjects were randomly assigned to receive microbial cell preparation (N = 68) or a placebo (N = 68) for 12 weeks. The outcomes measured at baseline, week 6, and week 12 and included changes in renal profile (Sodium, Potassium, Urea, Creatinine, Glomerular Filtration Rate), and liver function tests (Albumin, Total Protein, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase). Intention to treat (ITT) analysis was performed on all the recruited subjects, while per protocol (PP) analysis was conducted on those who completed the trial with good compliance. Result: The urea levels significantly declined in the probiotic group. Serum urea levels reduced from 4.26 mmol/L to 4.04 mmol/L in Probiotic Group while it increased in Placebo Group from 4.03 mmol/L to 4.24 mmol/L. These changes were significant between groups in ITT analysis (p = 0.018). Other parameters did not change significantly between groups. Conclusion: 12 weeks supplementation with daily dosage of 6 x 10(10) Colony Forming Units of multi-strain microbial cell preparation significantly improved urea levels

Nutritional status, glycemic control and its associated risk factors among a sample of type 2 diabetic individuals, a pilot study

Background: The prevalence of type 2 diabetes is increasing in Malaysia, with most patients poorly controlled. Hence, this study aimed to determine nutritional and metabolic status as well as blood pressure of Malaysian patients with type 2 diabetes mellitus and identify associated risk factors for poor glycemic control. Materials and Methods: A total of 104 type 2 diabetic patients were recruited and completed a questionnaire covering socio-demographic status, 3-day diet records, and physical activity. Anthropometry and glycemic control parameters, lipid profile and blood pressure were also measured. Results: Subjects were on average 56.7±9.9 years old with a mean duration of diabetes of 6.5 ± 5.0 years. The mean hemoglobin A1c of the subjects was 7.6% ± 1.4%, with only 20.2% achieving the target goal of <6.5% with no significant differences between genders. The mean body mass index was 26.9 ± 4.7 kg/m2, with 86.5% either were overweight or obese. Only 10.6% of the subjects exercised daily. The proportions of macronutrients relative to total energy intake were consistent with the recommendations of most diabetes associations. The adjusted odds of having poor glycemic control were 3.235 (1.043-10.397) (P < 0.05) higher among those who had high density lipoprotein cholesterol levels below the normal range. Those taking one or two types of oral anti-diabetic drugs had 19.9 (2.959-87.391) (P < 0.01) and 14.3 (2.647-77.500) (P < 0.01) higher odds of poor glycemic control respectively compared to those who were being treated by diet alone. Conclusion: Poor glycemic control was prevalent among Malaysian diabetic patients, and this could be associated with low levels of HDL and being treated with oral anti-diabetes agents

Effect of multi-strain probiotics (multi-strain microbial cell preparation) on glycemic control and other diabetes-related outcomes in people with type 2 diabetes: a randomized controlled trial

Aim: Evidence of a possible connection between gut microbiota and several physiological processes linked to type 2 diabetes is increasing. However, the effect of multi-strain probiotics in people with type 2 diabetes remains unclear. This study investigated the effect of multi-strain microbial cell preparation—also refers to multi-strain probiotics—on glycemic control and other diabetes-related outcomes in people with type 2 diabetes. Design: A randomized, double-blind, parallel-group, controlled clinical trial. Setting: Diabetes clinic of a teaching hospital in Kuala Lumpur, Malaysia. Participants: A total of 136 participants with type 2 diabetes, aged 30–70 years, were recruited and randomly assigned to receive either probiotics (n = 68) or placebo (n = 68) for 12 weeks. Outcomes: Primary outcomes were glycemic control-related parameters, and secondary outcomes were anthropomorphic variables, lipid profile, blood pressure and high-sensitivity C-reactive protein. The Lactobacillus and Bifidobacterium quantities were measured before and after intervention as an indicator of successful passage of the supplement through gastrointestinal tract. Statistical analysis: Intention-to-treat (ITT) analysis was performed on all participants, while per-protocol (PP) analysis was performed on those participants who had successfully completed the trial with good compliance rate. Results: With respect to primary outcomes, glycated hemoglobin decreased by 0.14 % in the probiotics and increased by 0.02 % in the placebo group in PP analysis (p < 0.05, small effect size of 0.050), while these changes were not significant in ITT analysis. Fasting insulin increased by 1.8 µU/mL in placebo group and decreased by 2.9 µU/mL in probiotics group in PP analysis. These changes were significant between groups at both analyses (p < 0.05, medium effect size of 0.062 in PP analysis and small effect size of 0.033 in ITT analysis). Secondary outcomes did not change significantly. Probiotics successfully passed through the gastrointestinal tract. Conclusion: Probiotics modestly improved HbA1c and fasting insulin in people with type 2 diabetes

Effect of multistrain probiotic supplementation in individuals with type 2 diabetes mellitus

Probiotics is reported as one of the option to achieve optimum glycemic control. While findings in animal models were convincing, evidences from human clinical trial are still controversial. To address this research gap, the double blind randomized controlled trial was conducted to investigate the effect of 12 weeks supplementation with multistrain probiotics in individuals with type 2 diabetes. A total of 136 participants with Type 2 Diabetes and aged 30-70 (mean Body Mass index (BMI): 29.2 kg/m2 in Probiotic Group and 29.3 kg/m2 in Placebo Group; Mean Glycated Hemoglobin (HbA1c): 7.6% in Probiotic Group and 7.5% in Placebo Group) participated in the study. Participants were asked to maintain their dietary intake and physical activity levels throughout the study. Participants were randomly assigned to receive daily dose of 6×1010 multistrain probiotic supplement. Changes in glycemic control variables, anthropometric measures, BMI, fasting lipid, renal profile, liver function, blood pressure, and high sensitivity C-reactive protein were measured at baseline, week 6 and 12 of the study. Adherence was assessed by calculating the number of remaining sachets. In a sub-samples (n=40), their stool were collected to determine the Colony Forming Units (CFUs) of Lactobacillus and Bifidobacterium using the plate count method. Sensitivity analyses namely Intention to Treat (ITT) and Per Protocol (PP) analyses were performed using General Linear Model Analysis of Variance. The ITT analysis conducted on the full set of data while the PP analysis was performed on those who have completed the study with more than 85% adherence. Baseline characteristics of the participants were comparable in both groups except for the liver status. The attrition rate was 20.6%. Participants maintained their dietary intake and physical activity throughout the study period. HbA1c decreased 0.2% in Probiotic Group while remains unchanged in Placebo Group. These differences were not significant between Probiotics and Placebo Groups in ITT analyses but in PP analysis, the differences were significant (p=0.017). Fasting insulin increased 0.8 μU/mL in the Placebo Group and decreased 1.6 μU/mL in the Probiotic Group. These changes were significant in both the ITT (p=0.020) and PP (p=0.016) analyses. Serum urea levels reduced by 0.22 mmol/L in the Probiotic Group while it increased by 0.21 mmol/L in Placebo Group and the differences were significant in ITT analysis (p=0.018). Other outcomes did not change significantly between groups. In a subsamples, the Lactobacillus (from 6.4×106 to 1.3×107 CFU/g; p=0.05) and the Bifidobacterium (from 3.4×106 to 1.3×107 CFU/g; p=0.02) species were significantly increased in Probiotics Groups as compared to Placebo Group in ITT Multistrain probiotics supplementation for a 12-week period influenced glycemic control variables and diabetes-related outcomes in individuals with Type 2 Diabetes. It was effective to improve the fasting insulin and urea levels as well. The improvements in HbA1c levels were also greater among those participants who have completed the trial with good adherence

Adherence to the vegetarian diet may increase the risk of depression: a systematic review and meta-analysis of observational studies

CONTEXT: Several epidemiological studies have investigated the association between a vegetarian diet and risk of depression, but because of inconsistency between studies, the exact association remains unclear. OBJECTIVE: In this systematic review and meta-analysis, the relationship between vegetarian diets and risk of depression in observational studies was evaluated. DATA SOURCES: The Medline, Embase, Scopus, ISI Web of Science, and Cochrane Library databases were searched from inception through September 1, 2020. STUDY SELECTION: Observational studies were included that examined mean levels of depression and risk for depression in vegetarians compared with nonvegetarians. DATA EXTRACTION: Pooled effect sizes were estimated using the random-effects model and were reported as standardized mean differences or odds ratios (ORs) with their corresponding 95%CIs. Heterogeneity was tested using the I2 statistic. RESULTS: Combining 9 effect sizes in this meta-analysis illustrated that adherence to a vegetarian diet was associated with a 53% greater risk of depression compared with that of omnivores (95%CI, 1.14-2.07; I2 = 69.1%). Subgroup analysis of depression risk suggested that results depended on the type of vegetarian diet and country where the study was conducted. For studies that assessed a semivegetarian diet (OR, 1.86; 95%CI, 1.42-2.44; I2 = 35.7%) and those conducted in Europe and the United States (OR, 1.45; 95%CI, 1.06-1.98; I2 = 73.2%), there was a positive association between a vegetarian diet and depression, but in lacto-ovo vegetarians and Asian countries, a null association was found. Comparing mean depression scores showed no evidence of difference between vegetarians and nonvegetarians (n = 16; standardized mean difference, 0.10; 95%CI, -0.01 to 0.21; I2 = 79.1%). CONCLUSION: Vegetarian diet significantly increased depression risk; however, the findings were not robust, and more studies are required to investigate the vegetarian diet and depression association

Nutritional status, glycemic control and its associated risk factors among a sample of type 2 diabetic individuals, a pilot study

Background: The prevalence of type 2 diabetes is increasing in Malaysia, with most patients poorly controlled. Hence, this study aimed to determine nutritional and metabolic status as well as blood pressure of Malaysian patients with type 2 diabetes mellitus and identify associated risk factors for poor glycemic control. Materials and Methods: A total of 104 type 2 diabetic patients were recruited and completed a questionnaire covering socio-demographic status, 3-day diet records, and physical activity. Anthropometry and glycemic control parameters, lipid profile and blood pressure were also measured. Results: Subjects were on average 56.7±9.9 years old with a mean duration of diabetes of 6.5 ± 5.0 years. The mean hemoglobin A1c of the subjects was 7.6% ± 1.4%, with only 20.2% achieving the target goal of <6.5% with no significant differences between genders. The mean body mass index was 26.9 ± 4.7 kg/m 2 , with 86.5% either were overweight or obese. Only 10.6% of the subjects exercised daily. The proportions of macronutrients relative to total energy intake were consistent with the recommendations of most diabetes associations. The adjusted odds of having poor glycemic control were 3.235 (1.043-10.397) (P < 0.05) higher among those who had high density lipoprotein cholesterol levels below the normal range. Those taking one or two types of oral anti-diabetic drugs had 19.9 (2.959-87.391) (P < 0.01) and 14.3 (2.647-77.500) (P < 0.01) higher odds of poor glycemic control respectively compared to those who were being treated by diet alone. Conclusion: Poor glycemic control was prevalent among Malaysian diabetic patients, and this could be associated with low levels of HDL and being treated with oral anti-diabetes agents

Weighing the evidence of low glycemic index dietary intervention for the management of gestational diabetes mellitus: an Asian perspective

This review aims to evaluate the effectiveness of low glycemic index (GI) dietary intervention for the treatment of gestational diabetes mellitus (GDM), specifically from the Asian perspective. A systematic review of the literature using multiple databases without time restriction was conducted. Three studies were retrieved based upon a priori inclusion criteria. While there was a trend towards improvement, no significant differences were observed in overall glycemic control and pregnancy outcomes in GDM women. However, a tendency for lower birth weight and birth centile if the intervention began earlier was noted. Low GI diets were well accepted and had identical macro-micronutrient compositions as the control diets. However, due to genetic, environment and especially food pattern discrepancies between Western countries and Asians, these results may not be contributed to Asian context. Clearly, there are limited studies focusing on the effect of low GI dietary intervention in women with GDM, particularly in Asia

Additional file 3: of Effect of microbial cell preparation on renal profile and liver function among type 2 diabetics: a randomized controlled trial

Changes in Dietary intake and physical activity level at baseline, week 6 and week 12. (XLSX 11 kb