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Targeting Obesity With the Probiotic Lactiplantibacillus Plantarum IMC 510 (PRO-Weight-Control Study)

NCT05358301 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-02-02

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Probiotic

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).

DIETARY_SUPPLEMENT

Placebo

N°1 capsule/day of placebo food supplement (i.e., capsules without added probiotics), with the same intake modalities as probiotic.

Sponsors & Collaborators

  • Azienda Ospedaliero-Universitaria Careggi

    lead OTHER

Principal Investigators

  • Francesco Sofi, Prof. · Unit of Clinical Nutrition, University hospital of Careggi, Florence, italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-07
Primary Completion
2022-06-30
Completion
2022-10-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05358301 on ClinicalTrials.gov