Targeting Obesity With the Probiotic Lactiplantibacillus Plantarum IMC 510 (PRO-Weight-Control Study)
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      Over the past 25 years, more than 120 drugs have been studied for the treatment of obesity,
      but only very few have been approved and maintained on the market. Although exercise and diet
      are the first lines of intervention in correcting overweight, obesity and related metabolic
      diseases, because they are measures that must be adopted and followed for a long period of
      time, often experience failure or poor outcomes. Currently there is an increased interest in
      alternative and effective short term non-pharmacological approaches to weight control that
      involve the use of natural active ingredients. The use of specific probiotics could represent
      the future weapon to fight obesity through the modulation of the intestinal microbiota, which
      is becoming more and more important as a critical point both for the appearance of many
      diseases (if altered) and for the possibility of curing them by intervening to restore the
      intestinal flora.

      Objectives of the study

      The present clinical study is directed to the evaluation of the efficacy of a probiotic
      formulation containing the probiotic strain Lactiplantibacillus Plantarum IMC 510 in inducing
      and supporting weight loss and reduction of body circumferences in overweight or obese
      subjects through the regularization of appetite with consequent reduction of food intake.

      Primary Objectives:

      1) To evaluate weight reduction in obese and/or overweight subjects after 3 months of
      treatment with probiotic or placebo.

      Secondary Objectives:

        1. Collection of blood and fecal samples at recruitment, after 3 months of treatment
           (probiotic or placebo), and after a 1-month final wash out.

        2. Measurement of BMI, body circumferences, body composition such as fat mass, lean mass,
           after 3 months of probiotic or placebo treatment, and after 1 month of wash out

        3. Evaluation of general well-being, eating habits and any gastrointestinal symptoms

        4. Comparison of hematological and biochemical parameters related to obesity at baseline,
           after 3 months of probiotic or placebo intervention, and after 1 month of washout

        5. Analysis of the composition of the intestinal microbiota and the production of
           short-chain fatty acids (SCFA) and bile acids (FBA).
    

Intervention name(s): Probiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Probiotic food supplement produced by SYNBIOTEC S.r.l. Each capsule of SYNBIO®slim contains the probiotic strain Lactiplantibacillus Plantarum IMC 510 at a concentration of 15 billion live cells (CFU/capsule). The assumption is of n°1 capsule/day, preferably at breakfast, for 3 months. The capsules can be opened and their content can be dispersed in a cold liquid or at intake temperature or in semi-solid food. Always store in original container or in a clean covered container, out of the reach of children. When stored in a dry, clean environment, out of direct sunlight, the product has a shelf-life of at least 24 months. Samples of probiotic supplement in closed and sealed boxes will be provided to subjects participating at the beginning of the study, in quantities sufficient for the entire duration of the study (90 capsules for 3 months).; N°1 capsule/day of placebo food supplement (i.e., capsules without added probiotics), with the same intake modalities as probiotic.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized double-blind parallel controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity; probiotic; Lactiplantibacillus Plantarum; gut microbiota; clinical trial