The Use of a Probiotic Blend in Reducing Anthropometric Measurements and Improving Biochemical Parameters in Adults With Overweight and/or Obese
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Body fat composition by Bioelectrical impedance analysis
研究概览
简要总结
It is already known that dysbiosis, that is, qualitative and quantitative changes in the composition of the intestinal microbiota, can be associated with the development of a series of intestinal and extra-intestinal disorders. Dysbiosis is reported in irritable bowel syndrome, inflammatory bowel disease, colorectal cancer, allergic diseases, non-alcoholic steatohepatitis, arteriosclerotic diseases, neurological diseases and metabolic syndromes, mainly diabetes and obesity. Among the many factors that play a key role in obesity, a number of studies show the intestinal microbiota as an important contributor. Many studies carried out with probiotics have shown that their administration can be effective in the prevention and treatment of obesity. Furthermore, it is found that benefits for body weight, abdominal adiposity, anthropometric measurements and body composition are often associated with favorable metabolic effects.
详细描述
Obesity is defined as excessive accumulation of body fat, caused by an energy imbalance. Approximately 13% of the world's adult population is obese, and in Brazil 19.8% of adults are obese. This disease is a risk factor for the development of other non-communicable chronic diseases (NCDs), such as: type 2 diabetes mellitus (DM2), dyslipidemia, cardiovascular diseases, musculoskeletal disorders and some types of cancer. It is a complex and multifactorial disease, which is why it is considered difficult to control and a cause for global concern. Among the causes of the disease, genetic, environmental and psychological factors can be mentioned, in addition to the interference of the intestinal microbiota, among others.
The interaction of the intestinal microbiota with the host has been studied through metabolomics, in order to understand the influence that the microbiota can exert on the functioning of the host organism. The study of the profile of low molecular weight metabolites of biological fluids such as serum/plasma and urine aims to understand the metabolic changes that occur in individuals with obesity, encompassing the understanding of the mechanisms of the disease.
Studies have shown differences in the metabolic profile of obese individuals compared to eutrophic individuals, with a positive correlation between body mass index (BMI) and increased concentrations of chain amino acids (BCAA) and glutamate. The gut microbiota appears to play a crucial role in host metabolism, being a pathway through which it leads to changes associated with obesity.
In this context, the intestinal microbiota can be modulated by prebiotics, probiotics and symbiotics, promoting changes in its composition, resulting in the regeneration of the intestinal barrier and, with that, ceasing metabolic endotoxemia and low-grade inflammation.
In addition, they have effects on the modulation of the immune system, regulating the production of pro and anti-inflammatory cytokines, reducing IR. Through these mechanisms, probiotics and symbiotics alter the microbiota profile of individuals leading to loss of body weight and metabolic parameters associated with obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of Free and Informed Consent in writing, signed and dated;
- •Age according to the indicated population (18-65 years old)
- •both genders;
- •Body mass index (BMI) of 25 - 35 Kg/m2.
排除标准
- •Pregnant and lactating women
- •Individuals with a history of daily consumption of probiotics, fermented milk and/or yogurt; subjects known to have demonstrated a prior reaction, including anaphylaxis, to any substance in the composition of the study product;
- •Individuals with concomitant participation in another clinical trial;
- •History of autoimmune, cardiovascular, thyroid, or chronic liver disease;
- •Making use of medication capable of affecting weight change, antidiabetic medication, hypolipidemic agents;
- •Individuals who have undergone weight loss surgery,
- •Weight change greater than 5% in the last three months.
结局指标
主要结局
Body fat composition by Bioelectrical impedance analysis
时间窗: three months
By Bioelectrical impedance analysis (BIA). This is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body.
次要结局
- quality of life questionnaire score(three months)
- Total cholesterol by blood analyses(three months)
- Weight(three months)
- HDL levels by blood analyses(three months)
- Gastrointestinal Symptom Rating Scale (GSRS) questionnaire score(three months)
- height(three months)
- LDL levels by blood analyses(three months)
- triglycerides levels by blood analyses(three months)
- Glucose levels by blood analyses(three months)
研究者
Monique Michels
PhD
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude