Investigating the effect of Familact probiotic supplement on blood sugar indices, lipid profile and insulin level in patients with type 2 diabetes.

Dissertation for Master's Degree in Health Sciences in Nutrition

Persian abstract

Context: Probiotics are useful bacteria that prevent the growth of microbes and the connection between them and the surface of the intestinal mucosa, and therefore play a useful role in the balance of intestinal flora. In several animal studies, the effect of probiotics on blood sugar control, blood insulin and delaying the occurrence of high blood sugar has been reported. However, very few human studies have been conducted in this field, which requires wider and more research.

Aim: Therefore, considering the increasing prevalence of this disease, the present study was conducted with the aim of investigating the effect of the pure probiotic Familact supplement on fasting blood sugar and insulin indices and the lipid profile of patients with type 2 diabetes.

Method: This is a double-blind, randomized controlled clinical trial. It was done on 60 patients with type 2 diabetes referred to Taleghani Hospital in Tehran. Individuals in the Moore intervention group received 2 probiotic capsules daily containing 7 strains of Lamtobacillus and Bifidobacter in a dose of 1010 CFU, and the placebo group received 2 placebo capsules containing magnesium stearate daily for 6 weeks. Their diet was evaluated with a 24-hour and 3-day food recall questionnaire. Food intake, anthropometric indices including weight, body mass index, waist circumference, underbust circumference and hip circumference, along with biochemical indices such as fasting blood sugar, fasting blood insulin and lipid profile (including total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride) were measured and evaluated at the beginning and end of the study. Statistical analysis was also done using SPSS software, using chi-square test, T test and analysis of variance.

Findings: Finally, it was observed that the average fasting blood sugar in the probiotic group decreased significantly compared to before the intervention (P=0.001), although it did not reach a significant level in the comparison between groups. Also, at the end of the study, the amount of HDL cholesterol in the probiotic group increased significantly compared to its value before the intervention (P=0.006), but this increase was not significant in the comparison between groups. Partial and intra-group increase in insulin and blood cholesterol, decrease in LDL cholesterol and insulin resistance and triglyceride did not reach a significant level. In addition, despite the decrease in weight and body mass index, waist circumference and chest circumference of people after probiotic intervention, these changes were not significant either at the intra-group or inter-group level. The intra-group and inter-group comparison of hip circumference values ??did not reach a significant level. (P <0.05).

Conclusion: Considering the beneficial effect of probiotic supplement consumption in reducing blood sugar and increasing useful fat in diabetic patients, the use of this supplement can be recommended as an auxiliary treatment to reduce the complications of diabetes, such as cardiovascular diseases and hyperlipidemia, or to prevent the development of diabetes in pre-diabetics. However, due to the few human studies in this field, more and more extensive studies are needed.

Keywords: probiotics, type 2 diabetes, fasting blood sugar, insulin, lactobacillus

- Introduction

Today, diabetes is one of the most common diseases in the world, which affects half of the world's population. The treatment of diabetes is different depending on its type. In type 1 diabetes, the main treatment is based on receiving insulin as the most important chemical drug, while in type 2 diabetes, due to the presence of environmental factors, various main treatments are used, including drug and chemical treatments, lifestyle changes (increasing physical activity, reducing stress, and quitting smoking), dietary changes, and natural treatments. Therefore, in type 2 diabetes, today, most of the effort is to reduce the amount of chemical drugs used in this disease by changing people's lifestyle and using natural treatments, including herbal treatments and other natural substances, and prevent the progression or even the development of this disease. Because now more than ever, doctors emphasize the diagnosis of hidden diabetes as a way to prevent type 2 diabetes and its complications, including cardiovascular, eye and kidney problems.For this reason, in this research, the effect of probiotics as a natural substance that can have therapeutic or preventive properties on type 2 diabetes is investigated. In diabetes, due to the occurrence of insulin resistance, the plasma insulin level increases and due to the disorder that occurs in the glucose metabolism, it ultimately leads to an increase in the blood glucose level. Plasma total cholesterol, LDL-C and VLDL-C levels increase and HDL-C decreases. Changes in lipid profile can be one of the causative factors inducing cardiovascular diseases in diabetic patients. Additionally, higher triglyceride levels lead to the development of insulin resistance (Association 2014). 

Asians who still follow the traditional way of life, based on low expenses and hard work, face only one percent of diabetes in adults. While Asians who have adopted the western way of life have shown a higher prevalence. In the case of the Chinese immigrants who live in a modernized island in the Indian Ocean, 20% of the population have diabetes (King et al. 1998). According to the latest articles published in Iran, the prevalence of diabetes in the entire population of Iran is estimated at 7-8% in 2017, and this disease was the 16th cause of death in men and the 9th cause of death in Iranian women. According to the latest statistics available in Iran, by 2016, one out of every 20 Iranians will suffer from diabetes, and it is expected that one out of every seven Iranians will suffer from diabetes in the next 18 years, i.e. in 1404 (Azizi et al. 2007). 

Also, according to the latest statistics of the "International Diabetes Federation" (IDF), in 2013, more than 3.4 million people in Iran were diagnosed with diabetes, and the prevalence of this disease among the adult population aged 20 to 79 years was estimated at 43.8% this year. Also, about 38,002 people died due to diabetes and so far 2,198 people with diabetes in Iran have not been statistically diagnosed. Meanwhile, the average healthcare costs for people with diabetes in Iran are estimated at $471 per person (IDF 2013).  

Diabetes threatens the developing countries that tend to live in western life with a lot of food and little movement. Due to the increasing number of people with diabetes in the world and the importance of paying attention to the complications caused by this disease, finding prevention and treatment methods for this disease has been of interest to researchers for years (WHO 2011; Mahan et al. 2012). 

On the other hand, direct medical costs such as hospitalization, outpatient services, nursing care at home are high, and indirect costs such as disability, job loss, and early death are also high. Thus, in general, the average medical costs of people with diabetes are 2 times that of non-diabetic people. Therefore, creating therapeutic nutrition or MNT through food interventions and with the aim of preventing and treating diabetes and reducing costs will be very effective. Today, many studies are being conducted to produce or examine the benefits of functional foods, and one of the aspects of interest is the research on the anti-diabetic effects of these foods (Mahan et al. 2012).  In fact, studies indicate that it is possible to create positive effects on the recovery of patients with diabetes by dietary interventions and changing the intestinal microbial flora (Dalla Vestra et al. 2005; Ejtahed et al. 2011; Asemi et al. 2013).

A group of functional foods are food products containing probiotics. Probiotics are considered as live microorganisms of the digestive tract and when sufficient amounts of them reach the human body, they have positive effects on the health of the host by changing the composition of the intestinal flora. And among them, lactobacillus and bifido bacteria play an important role in the prevention of many diseases. They also have other effects such as stimulating the immune system, cleaning the intestine from pathogenic bacteria, producing bioactive substances, anti-carcinogenic activity, improving lactose intolerance, preventing intestinal infection (Roberfroid 2000; Grover et al. 2012).