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ORIGINAL ARTICLE
Year : 2019  |  Volume : 10  |  Issue : 1  |  Page : 2-7  

Impact of probiotics on health-related quality of life in Type II diabetes mellitus: A randomized single-blind, placebo-controlled study


Department of Pharmacy Practice, Sri Adichunchanagiri College of Pharmacy, Mandya, Karnataka, India

Date of Web Publication4-Feb-2019

Correspondence Address:
Rajesh Venkataraman
Department of Pharmacy Practice, Sri Adichunchanagiri College of Pharmacy, BG Nagar, Nagamangala, Mandya - 571 448, Karnataka
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jnsbm.JNSBM_31_18

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   Abstract 


Objective: The objective of this study is to analyze the impact of probiotics on health-related quality of life (HRQOL) of type 2 diabetes mellitus (T2DM) patients. Materials and Methods: This was a prospective, interventional single-blind, randomized study; a total of 80 T2DM patients were randomized as single blinded into two groups: interventional group consuming pre and probiotic capsules and control group consuming placebo capsules capsules; the study was conducted for a duration of 3 months, and the readings were recorded at 0, 6, and 12 weeks from all participants for the analysis of HRQOL. Results: Seventy-five participants out of 80 completed the study. Glucose markers such as fasting blood sugar (P = 0.42), postprandial blood sugar (P = 0.60), homeostatic model assessment-insulin resistance (P = 0.20), and serum insulin (P = 0.22) had shown beneficial effect on HRQOL of the T2DM patients. The influence of gender on HRQOL was not noteworthy (P = 0.68), whereas age had shown significant influence on HRQOL of the patients (P = 0.02) with the use of probiotics. Conclusion: The results of study had shown important improvement in HRQOL of the T2DM patients with the use of probiotics in the interventional group compared to the control group.

Keywords: Glycemic control, health-related quality of life, homeostatic model assessment-insulin resistance, probiotics, serum insulin, type 2 diabetes mellitus


How to cite this article:
Venkataraman R, Jose P, Jose J. Impact of probiotics on health-related quality of life in Type II diabetes mellitus: A randomized single-blind, placebo-controlled study. J Nat Sc Biol Med 2019;10:2-7

How to cite this URL:
Venkataraman R, Jose P, Jose J. Impact of probiotics on health-related quality of life in Type II diabetes mellitus: A randomized single-blind, placebo-controlled study. J Nat Sc Biol Med [serial online] 2019 [cited 2019 Dec 10];10:2-7. Available from: http://www.jnsbm.org/text.asp?2019/10/1/2/251505




   Introduction Top


The unabated increase in the prevalence of diabetes mellitus is the most alarming public health issues encountered in the clinical practice world today. The World Health Organization (WHO) characterizes health as a condition of complete physical, mental, and social well-being and not simply the absence of disease. In general, quality of life extends beyond health. Estimation of health must incorporate not only estimates of the frequency and seriousness of the illness but also conjointly well-being and health-related quality of life (HRQOL).[1] HRQOL is an evolving, multidimensional construct of physical, psychological, and functional well-being that is increasingly used as an outcome in effectiveness research, examining that the effects of a disease or intervention on individuals' health particularly useful are preference-based HRQOL instrument.[2] Type 2 diabetes mellitus (T2DM) is a complex chronic disease which is able to create radical lifestyle modifications in healthy individuals, and patients were needed to vary their normal life in accordance to manage their blood glucose level and preventing comorbidities of diabetes such as cardiovascular disease, kidney disease, disability, delayed wound healing, and visual impairment.[3],[4] T2DM negatively affects the individuals in the aspect of both the psychological and emotional well-being of patients and can cause reduced quality of life in comparison with the healthy individuals. The existence of life with diabetes has an effect on patients' physical and social functioning as well as their work, and the daily routine of a healthy individual will get modified with the reduction of the confidence and fearlessness that inspire adventures and motivation in the patients' lives upon the diagnose of diabetes.[5],[6] The fear of hypoglycemia, change in lifestyle, and worries of complications may lead the diabetic patients to depression and results in serious deterioration of HRQOL.[7] In reality, diabetic individuals have reduced HRQOL compared with those without diabetes in the same age group, and their HRQOL decreases with disease progression and complications. Many variables have been associated with HRQOL in patients with diabetes mellitus such as age, gender, obesity, treatment, chronic complications, quality of care, and patient education.[8],[9]

The WHO defines probiotics as live microorganisms which when administered in suitable amounts contribute a health advantage to the host.[10] Diabetes mellitus is associated with dysbiosis, and regular ingestion of probiotics helps to bring back a healthy gut microbiota. Probiotics have shown to reduce the systemic inflammation and oxidative damage associated with diabetes mellitus, and the actions of probiotics against insulin resistance are exerted by increasing liver natural killer T-cells.[11],[12] Systemic inflammation and increased oxidative stress are necessary in the pathophysiology of T2DM.[13] Consumption of probiotics has been evidenced to scale back inflammation and oxidative stress markers and to improve glycemic control and insulin metabolism.[14],[15]

In recent years, several efforts have been made on usage of traditional medicines as complementary or adjuvant therapy besides conventional drug treatment in diabetes. Probiotics have therefore been advised for diabetic patients. Probiotics are live microorganisms that induce a health benefit once administered in adequate quantities.[14] These advantages are achieved by stimulating beneficial gastrointestinal indigenous microflora proliferation. The consumption of probiotics with lactic acid producing property in human origins such as bifidobacteria and lactobacilli might decrease the serum level of glucose and glucose tolerance in diabetes and confer a higher quality of life to the host.[15]

A study conducted in University of Cambridge School of Clinical Medicine, UK, showed a decreased risk of T2DM associated with yogurt intake.[16] Another study conducted in Brazil suggested that probiotic consumption improves glycemic control in T2DM patients with a reduction in fructosamine levels and glycosylated hemoglobin (HbA1C) levels.[17] A study conducted in Iran showed that the consumption of probiotic yogurt results in significant decrease in HbA1C and tumor necrosis factor-alpha levels in the intervention group.[18]

There were limited studies focusing on the predictors of probiotic-induced HRQOL among Indian diabetic patients. Against this background, the objective of this study was to analyze the effects of probiotics on HRQOL in T2DM patients.


   Materials and Methods Top


The present study was a prospective, interventional, single-blind, single-centered, randomized study. The study was approved by institutional ethics committee of Adichunchangiri Institute Of Medical Sciences, B.G Nagara, Karnataka. Patients were recruited from the outpatient Department of medicine from February 2017 to April 2017. Patients of either gender between 18 and 65 years of age were enrolled after the provision of written, vernacular consent. The study was registered under Clinical Trials Registry–India (Registration Number-CTRI/2017/06/008761).

Methodology

All eligible patients underwent baseline evaluation for recording demographic details, medical history, and laboratory tests including homeostatic model assessment-insulin resistance (HOMA-IR), serum insulin, fasting blood sugar (FBS), and postprandial blood sugar (PPBS). Overall, eighty patients were recruited into the study; computerized randomizer was used for randomization. The participants were randomized into interventional and control groups with forty participants in each group (single-blind), where the intervention group received pre and probiotic capsule while the control group received placebo capsules for a period of 3 months.

In our study, patients in the test group received pre and probitoc capsules containing Lactobacillus salivarius UBLS 22 (5 Billion cfu), Lactobacillus casei UBLC 42 (5 Billion cfu), Lactobacillus plantarum UBLP 40 (5 Billion cfu), Lactobacillus acidophilus UBLA 34 (5 Billion cfu), Bifidobacterium breve UBBR 01 (5 Billion cfu), Bacillus coagulans Unique-IS2 (5 Billion cfu) and fructooligosaccharide (100 mg) per capsule. The placebo capsules were identical looking to the pre and probiotic capsules capsules but did not contain any of the active ingredients.

The study medications were distributed twice throughout the study period during the baseline reading (week 0) and first follow-up (week 6). Patients were advised to consume 2 capsules/day of either pre and probiotic capsules (30 billion cfu) or placebo depending upon the group they were assigned to. FBS, PPBS, HOMA-IR, and serum insulin were recorded at 0, 6, and 12 weeks in all participants for the assessment of the effect of probiotics on glycemic control. The suitably designed data collection form and pretested questionnaires that were studied for reliability and validity were used to collect all the necessary information [Table 1]. HRQOL was assessed through questionnaires in the baseline and end point of the study to evaluate the effect of probiotics in the T2DM patients.
Table 1: Questionnaire for the analysis of Health-Related Quality of Life In T2DM

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Clinical assessment parameters

FBS, PPBS, HOMA-IR, and serum insulin were measured.

Inclusion criteria

Adults of either sex, aged between 18 and 65, who were diabetic were considered.

Exclusion criteria

Critically ill patients and patients who were having significant immunodeficiency were excluded from the study. Patients who were consuming probiotics within 3 months before inclusion and individuals who took part in any clinical trial within the past 6 months were excluded from the study. Those who consumed alcohol >30 g and those who received antibiotics in the preceding 6 weeks of screening were left out.

Follow-up visits

Each patient was evaluated for a duration of 3 months. Patients were evaluated clinically at baseline 1st week and at subsequent follow-up visits on the 6th and 12th week.

Sample size

The power analysis indicated that a total sample of 60 participants, 30 in each group, were required to analyze the effect of probiotics in HRQOL in patients at the 0.05 level of significance with confidence interval (CI) at 95%; considering possible dropouts, 80 participants were recruited.

Statistical analysis

Statistical analysis was performed using the IBM SPSS version 17.0 (IBM, South Wacker Drive, Chicago IL, US) with a CI of 95% and a significant level of 0.05. Spearman rank correlation was run to evaluate the relationship between demographic variables and HRQOL and patient compliance. Wilcoxon signed-rank test was applied to compare pre- and postresults in both groups.


   Results Top


Eighty participants were included into the study by fulfilling the inclusion criteria and forty participants were randomized into each group, intervention group (pre and probiotic capsules) and control group (placebo capsules). Probiotic consumption compared with placebo considerably improved the HRQOL. Of total population in test group, 55% (n = 22) were male and 45% (n = 18) were female, whereas in control group, 50% (n = 20) were male and 50% (n = 20) were female. Gender had shown no significant influence on HRQOL of patients (P = 0.68).

The majority of the participants were in the age group of above 50 years followed by age group of 40–50 years and age group of 30–40 years. In test group, 62.5% of the patient population were above age 50 (n = 25), 25% come in between 40–50 years' age group (n = 10), and 12.5% were below the age group of 30–40 years (n = 5), whereas in the control group, 57.5% of the patient population were above age 50 (n = 23), 30% of patient population were under the age group of 40–50 years (n = 12), and 12.5% come under the age group of 30–40 years (n = 5).

HRQOL of patients belonging to the age group of 50 years in test group was 2.32 ± 0.54 when compared to control group 2.57 ± 0.63 as well as in the age group of 40–50 years was 2.40 ± 0.43 in test group when compared to control group 2.69 ± 0.52, whereas in the age group of 30–40 years, it was 2.50 ± 0.64 in test group and 2.78 ± 0.72 in control group. The age had shown a significant improvement in HRQOL (P = 0.02).

A comparison of results in test and control groups revealed glucose markers such as FBS (P = 0.42 and P = 0.32, respectively), PPBS (P = 0.60 and P = 0.40, respectively), HOMA-IR (P = 0.20 and P = 0.18, respectively), and serum insulin (P = 0.22 and P = 0.18, respectively) had shown beneficial effect on HRQOL with the use of probiotics in test group as compared to the control group [Table 2].
Table 2: Correlation

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[Figure 1] shows correlation analysis between test and control group in FBS, PPBS, HOMA-IR, and serum insulin.
Figure 1: Correlation of fasting blood sugar, postprandial blood sugar, homeostatic model assessment-insulin resistance, and serum insulin with health-related quality of life in test group and control group. (a) Correlation of FBS with HRQOL (b) Correlation of PPBS with HRQOL (c) Correlation of Homa-IR with HRQOL (d) Correlation of Serum Insulin with HRQOL

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Among test group with the use of probiotics, FBS, PPBS, HOMA-IR, and serum insulin positively correlates with HRQOL which clearly indicates an increase in HRQOL as compared to control group. The correlation was statistically significant (P < 0.01) [Figure 1] and [Table 2].

[Figure 1]a shows that there is a significant correlation (P < 0.01) between FBS and HRQOL with the use of probiotics in the test group than that of the control group. [Figure 1]b shows that there is a significant correlation (P < 0.01) between PPBS and HRQOL with the use of probiotics in the test group than that of the control group. [Figure 1]c shows that there is a significant correlation (P < 0.01) between HOMA-IR and HRQOL with the use of probiotics in the test group than that of the control group. [Figure 1]d shows that there is a significant correlation (P < 0.01) between serum insulin and HRQOL with the use of probiotics in the test group than that of the control group.


   Discussion Top


HRQOL plays a vital role in diabetes as its morbidity and mortality rates are higher. Diabetes causes a significant impairment of all aspects of HRQOL in affected individuals due to its progressive nature and risk of complications. Glycemic control plays a key role in preventing long-term complications and ensures a better QOL to diabetic patients. Measurement of HRQOL is an important outcome for the diabetes management. The burden imposed on patients by the diagnosis of T2DM destructively affects their HRQOL.[19]

Several published studies had shown the decreased quality of life in diabetic patients. A study conducted in Michigan by Coffey et al. on 2048 diabetic participants reported that major diabetes complications will result to poor HRQOL.[20] T2DM will impart depression and anxiety in individuals due to the changes in lifestyle and the fear of complications of diabetes, and a study done by van Dooren et al. at Maastricht University Medical Center in Netherland had shown a high prevalence of depression, anxiety, and type D personality in T2DM.[21]

Probiotics are viable microorganisms that offer health benefit to the host by altering the proliferation of beneficial gastrointestinal indigenous microflora. Boundless therapeutic advantages have been accounted with the supply of probiotics in irritable bowel syndrome, diarrhea, and lactose intolerance. In diabetes, alterations in intestinal microbiota lead to increased intestinal permeability and mucosal immune response; this may lead to increased blood glucose levels. Changes of intestinal microbiota by the administration of probiotics are effective toward the management of diabetes mellitus as probiotics can remodel the gut microbiota to a healthier one.[22],[23] Therefore, these modulations by the probiotics may bring improved HRQOL in diabetes. Several strains of these microorganisms had shown health benefits. However, Lactobacillus and Bifidobacterium are the most familiar probiotic bacteria used as food. In our study, there was an improvement in the quality of life of T2DM patients who received probiotics compared with placebo. Therefore, probiotic-mediated glycemic control could be a new strategy in the management of diabetes.

In the present study, patients consumed capsule containing L. salivarius UBLS 22 (5 Billion cfu), L. casei UBLC 42 (5 Billion cfu), L. plantarum UBLP 40 (5 Billion cfu), L. acidophilus UBLA 34 (5 Billion cfu), B. breve UBBR 01 (5 Billion cfu), B. coagulans Unique-IS2 (5 Billion cfu), and fructooligosaccharide (100 mg) twice a day for 3 months, probiotic consumption led to reduction in blood glucose levels and improvement in HRQOL. In the test group and control group, glucose markers such as FBS (P = 0.42 and P = 0.32, respectively), PPBS (P = 0.60 and P = 0.40, respectively), HOMA-IR (P = 0.20 and P = 0.18, respectively), and serum insulin (P = 0.22 and P = 0.18, respectively) had shown significant beneficial effect on HRQOL of the patient.

The beneficial effects of probiotics on HRQOL in diabetes through lowering the blood sugar levels have been confirmed by various studies across the world. A study conducted by Ostadrahimi et al. revealed that there is a reduction in blood glucose level after 8 weeks of consumption of fermented milk 600 ml/day containing probiotic microorganism's L. casei, L. acidophilus, and bifidobacteria.[24] In another study performed by Karamali et al., the patients in the probiotic group consumed a daily capsule that contained three viable freeze-dried strains: L. acidophilus (2 × 109 CFU/g), L. casei (2 × 109 CFU/g), and Bifidobacterium bifidum (2 × 109 CFU/g) for 6 weeks that resulted in reduction in blood glucose levels.[25]

In our study, age had shown a beneficial influence on HRQOL in T2DM patients (P = 0.02) with the use of probiotics in test group when compared to the control group. Improved HRQOL was evident as observed in the age group of 30–40 years. HRQOL reduced in the remaining age groups with the increase in age. However, a study conducted by Redekop et al. had shown that age is independent of HRQOL in T2DM patients.[26] A similar study carried out by Javanbakht et al. demonstrated that increased age in T2DM is associated with lower HRQOL.[27]

Our study demonstrated that consumption of probiotic capsules controlled blood glucose levels and improved HRQOL of the T2DM patients.

Limitations of our study were that the study was performed in short period, i.e., 3 months; the duration of the study could have been longer to observe the constant effects of probiotics; the sample size could have been more to see the impact of probiotics on a wide range of the diabetic population. This study can be a stimulation for upcoming related studies and reflected as an early step in the analysis of probiotics as a new approach in the management of diabetes.


   Conclusion Top


The findings of our study indicate that probiotic consumption had remarkable improvement of HRQOL and glycemic control in T2DM. Therefore, it is suggested that probiotics may be used as an adjuvant in treating T2DM.

Acknowledgment

We thank Unique Biotech Limited, India, for gifting the probiotic and placebo capsules for the study.

Financial support and sponsorship

The study was financially supported by Unique Biotech Pvt., Limited.

Conflicts of interest

There are no conflicts of interest.



 
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