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临床试验/NCT05358301
NCT05358301已完成不适用

Novel Strategies for Obesity Prevention and Management With the Probiotic Lactiplantibacillus Plantarum IMC 510 (PRO-Weight-Control Study)

Azienda Ospedaliero-Universitaria Careggi2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年1月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Body weight

研究概览

简要总结

In recent decades, the prevalence of obesity has reached epidemic proportions, with the number of overweight or obese individuals continuing to increase worldwide. Advances in recent research have allowed a better characterization of the etiology of obesity, demonstrating the involvement of the gut microbiota. In fact, while signals from the brain influence gut function, the gut microbiota has been shown to modulate brain functions involved in the regulation of stress, depression and anxiety, which are closely linked to obesity. Oral administration of probiotics has been proposed as a valid way to modulate the gut ecosystem to promote weight reduction. Preliminary data showed that obese rats treated with probiotics containing the probiotic strain Lactiplantibacillus Plantarum IMC 510 exhibited significantly lower weight and food intake than untreated obese rats. Although exercise and diet are the first lines of intervention to be recommended, there are often failures or poor outcomes. There is currently increased interest in alternative and effective shorter-term, non-pharmacological approaches to weight control that involve the use of natural active ingredients. Thus, the aim of this intervention study is to investigate whether a probiotic supplementation with Lactiplantibacillus Plantarum IMC 510 could be beneficial for the weight reduction of people with obesity.

详细描述

Background

Obesity is a multifactorial disease characterized by a chronic imbalance between energy intake and energy expenditure. Risk factors for weight excess are genetic, metabolic, hormonal, psychological, and social, as well as factors related to diet, sedentary lifestyle, and medication intake. Obesity is associated with an increased risk of onset of several metabolic diseases (high blood pressure, dyslipidemia, diabetes mellitus, metabolic syndrome), cardiovascular diseases (cerebral strokes, myocardial infarction), gastrointestinal diseases (esophageal reflux, cholelithiasis, pancreatitis, hepatopathy), respiratory diseases (apnea, respiratory failure), cancer (higher incidence of cancer and worsening of prognosis), osteoarticular diseases (osteoporosis, osteoarthritis), psychological diseases (depression, low self-esteem, relationship problems).

In recent decades, the prevalence of obesity has reached epidemic proportions. In fact, current data estimate that approximately 600 million people worldwide are obese, with an additional 1.9 billion overweight. Moreover, recent trend analyses show that the number of individuals who are overweight or obese continues to increase worldwide.

Advances in recent research have allowed for better characterization of the etiology of obesity, highlighting the potential contribution of factors not traditionally considered to be involved in changes in energy balance and body composition. Experimental and clinical studies have also demonstrated the role of the gut microbiota in the regulation of energy balance and the occurrence of excess body weight. In this regard, it has been suggested that lean and obese human subjects differ in the composition of their gut microbiota, and that probiotics and prebiotics can be used to modify the microbiota to prevent body weight gain. The bidirectional gut-brain connection allows signals from the brain to influence motility, appetite sensations, secretions, and permeability of the gut. Studies have demonstrated the role and importance of the gut microbiota in modulating central nervous system activity, so some gut messages may influence brain functions involved in the regulation of stress, depression, and anxiety, which are closely related to obesity. Consequently, the gut microbiota is a potential modifiable target for the prevention and/or treatment of obesity. In fact, the gut microbiota has recently been shown to play a complex role in body weight regulation and some probiotic strains have been able to ameliorate obesity status and related metabolic disorders. Preliminary data showed that obese rats treated with probiotics containing the probiotic strain Lactiplantibacillus Plantarum IMC 510 exhibited significantly lower weight and food intake than untreated obese rats.

Oral administration of probiotics has been proposed as a viable way to modulate/modify the gut ecosystem to promote weight reduction; however, the mechanisms by which probiotic supplementation may affect the gut microbiota of obese individuals are largely unknown. In addition, byproducts of the bacterial fermentation process may also reduce appetite and increase feelings of satiety, and through modulation of bile acid metabolism, the microbiota may reduce diet-induced obesity through increased energy expenditure. In addition, gut bacteria can manipulate an individual's taste and food preferences.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

By keeping both the experimenters and the participants blind, bias is less likely to influence the results of the experiment.

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

入选标准

  • Men and women 18-65 years of age
  • Obesity (BMI >30 kg/m2, class I, II, III) and overweight (BMI 25-29.9 kg/m2)
  • Willingness to cooperate during the study and ability to follow guidelines
  • Willingness to complete questionnaires and diaries associated with the study and to complete all clinical visits
  • Willingness to discontinue functional foods and dietary supplements with probiotics, laxatives and body weight control substances
  • Ability to provide informed consent

排除标准

  • Continued use of probiotics in the two months prior to treatment
  • Use of other treatments (medications or nutritional programs) that affect body weight, food intake and/or energy expenditure
  • Postmenopausal women
  • Pregnant or lactating
  • Enrolled in another obesity treatment program

结局指标

主要结局

Body weight

时间窗: 2 months

Changes of body weight from baseline assessed through a balance

次要结局

  • Fat mass(2 months)
  • Red blood cells(2 months)
  • Sodium(2 months)
  • Calcium(2 months)
  • ALT(2 months)
  • Uric Acid(2 months)
  • Total body water(2 months)
  • Hemoglobin(2 months)
  • Glucose(2 months)
  • Urea(2 months)
  • Fat-free mass(2 months)
  • White blood cells(2 months)
  • Magnesium(2 months)
  • Creatinine(2 months)
  • Potassium(2 months)
  • AST(2 months)
  • Triglycerides(2 months)
  • Total cholesterol(2 months)
  • HDL-cholesterol(2 months)
  • LDL-cholesterol(2 months)
  • eGFR(2 months)
  • Gastrointestinal and systemic symptoms(2 months)
  • Gut microbiota(2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesco Sofi

Associate Professor of Clinical Nutrition

Azienda Ospedaliero-Universitaria Careggi

研究点 (2)

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