Clinical trial NCT05358301: Targeting Obesity With the Probiotic Lactiplantibacillus Plantarum IMC 510 (PRO-Weight-Control Study)
Official title: Novel Strategies for Obesity Prevention and Management With the Probiotic Lactiplantibacillus Plantarum IMC 510 (PRO-Weight-Control Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
probiotic
Lactiplantibacillus Plantarum
gut microbiota
clinical trial
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized double-blind parallel controlled trial
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Body weight
timeFrame: 2 months
Secondary outcomes:
measure: Fat mass
timeFrame: 2 months
measure: Fat-free mass
timeFrame: 2 months
measure: Total body water
timeFrame: 2 months
measure: White blood cells
timeFrame: 2 months
measure: Red blood cells
timeFrame: 2 months
measure: Hemoglobin
timeFrame: 2 months
measure: Glucose
timeFrame: 2 months
measure: Urea
timeFrame: 2 months
measure: Creatinine
timeFrame: 2 months
measure: Sodium
timeFrame: 2 months
measure: Potassium
timeFrame: 2 months
measure: Calcium
timeFrame: 2 months
measure: Magnesium
timeFrame: 2 months
measure: AST
timeFrame: 2 months
measure: ALT
timeFrame: 2 months
measure: Triglycerides
timeFrame: 2 months
measure: Total cholesterol
timeFrame: 2 months
measure: HDL-cholesterol
timeFrame: 2 months
measure: LDL-cholesterol
timeFrame: 2 months
measure: Uric Acid
timeFrame: 2 months
measure: eGFR
timeFrame: 2 months
measure: Gastrointestinal and systemic symptoms
timeFrame: 2 months
measure: Gut microbiota
timeFrame: 2 months
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Unit of Clinical Nutrition, University Hospital of Careggi
Study officials:
affiliation: Unit of Clinical Nutrition, University hospital of Careggi, Florence, italy
name: Francesco Sofi, Prof.
role: PRINCIPAL_INVESTIGATOR
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