Effect of the Probiotic SF68® on Body Composition and Low-to-moderate Cardiovascular Risk

January 25, 2025 updated by: Francesco Sofi, Azienda Ospedaliero-Universitaria Careggi

Interventional, Randomized, Single-blind, Placebo-controlled Study to Evaluate the Effect of a Probiotic Formulation Based on SF68® on Body Composition and Low-to-moderate Cardiovascular Risk

Obesity is a multifactorial disorder of energy balance, characterized by an imbalance between energy intake and energy consumption. In recent decades, the prevalence of obesity has reached epidemic proportions. Advances in scientific research have enabled 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, such as the gut microbiota. Oral administration of probiotics has been proposed as a valid way to modulate the gut ecosystem to promote weight reduction. Preliminary data from a preclinical study in mouse models suggest that the dietary supplement SF68® containing the probiotic Enterococcus lactis as well as phytosterols and (6S)-5-methyltetrahydrofolic acid has the ability to significantly counteract weight gain. In addition to modulating the composition of the gut microbiota, it also has an impact on decreasing the levels of total cholesterol, low-density cholesterol (LDL), triglycerides, homocysteine, IL-1 β and LPS Binding Protein (LBP). Although exercise and diet are the first lines of intervention to be recommended, there are often failures or poor results. 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 supplementation with SF68® could be beneficial for the weight reduction and the improvement of cardiovascular risk profile of people with overweight or obesity.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Florence, Italy, 50124
        • Careggi University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Obesity (BMI >30 kg/m^2, class I, II, III) and overweight (BMI 25-29.9 kg/ m^2) and concomitant presence of at least one of the following risk factors detected by hematologic examinations performed within 1 year of the baseline screening visit:

    1. Circulating levels of total cholesterol >190 mg/dL, not on drug treatment
    2. Circulating levels of LDL cholesterol >115 mg/dL, not on drug treatment
    3. Circulating levels of triglycerides >150 mg/dL, not on drug treatment
  • Ability and willingness to cooperate during the study, adhere to the procedures stipulated in the protocol and comply with its requirements.
  • Ability and willingness to complete questionnaires required by the study and to complete all medical examinations required by the protocol.
  • Willingness to discontinue the consumption of functional foods and dietary supplements with probiotics, laxatives and body weight control substances starting 15 days before the screening view and until the conclusion of the study.
  • Willingness to maintain a healthy and balanced lifestyle for the duration of the study.
  • If female subject of childbearing age, must have a negative urine pregnancy test at screening and agree to use a reliable method of contraception throughout the study
  • Ability to provide written informed consent.

Exclusion Criteria:

  • Use of probiotics continuously, in the two months prior to the start of the study
  • Use of other treatments (medications or nutritional programs) that affect body weight or dyslipidemia, gut microbiota, food intake, and/or energy expenditure (e.g., Statins and Fibrates)
  • Antibiotic use
  • Weight loss or gain > 5 kg in the 3 months prior to the start of the study.
  • Pregnant or lactating women and women of childbearing age unwilling to use an adequate contraceptive method and take a pregnancy test at screening.
  • Concurrent enrollment in another or similar obesity treatment program

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Probiotic
Probiotic food supplement produced by Cerbios-Pharma SA
Dietary supplement: Probiotic
The experimental product is a dietary supplement manufactured by Cerbios-Pharma S.A, Each stick contains probiotic live cultures of Enterococcus lactis SF68® at a concentration of 10^9 CFU, phytosterols, 6S-5MeTHF, maltose and silicon dioxide. Study participants will be given N°3 packs each containing 30 stick packs of 1.7 g each, in granulated form in sufficient quantity for the entire duration of the study (12 weeks). Subjects will be required to consume N°1 stick pack of the supplement daily after dinner for 12 continuous weeks. The product should be placed directly on the tongue and should be taken without water. After taking the product, the subject should drink half a glass of water to promote solubilization and transit. The supplement should be stored in a cool, dry place, away from light, moisture and direct heat sources to ensure the viability of the probiotic strain until the expiration date.
Placebo Comparator: Placebo
Placebo food supplement
Dietary supplement: Placebo
N°1 stick/day of placebo food supplement (i.e., stick without added probiotics), with the same intake modalities as probiotic.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Waist circumference
Time Frame: 12 weeks
Changes of waist circumference from baseline assessed through a metric tape
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gut microbiota
Time Frame: 12 weeks
Changes of gut microbiota from baseline assessed by NGS technology
12 weeks
Short-chain fatty acids (SCFAs)
Time Frame: 12 weeks
Changes of SCFAs from baseline assessed by gas chromatography
12 weeks
Hemoglobin
Time Frame: 12 weeks
Changes of hemoglobin from baseline assessed to standard laboratory procedures.
12 weeks
White blood cells
Time Frame: 12 weeks
Changes of white blood cells from baseline assessed to standard laboratory procedures.
12 weeks
Red blood cells
Time Frame: 12 weeks
Changes of red blood cells from baseline assessed to standard laboratory procedures.
12 weeks
Platelets
Time Frame: 12 weeks
Changes of platelets from baseline assessed to standard laboratory procedures.
12 weeks
Glucose
Time Frame: 12 weeks
Changes of glucose from baseline assessed to standard laboratory procedures.
12 weeks
Insulin
Time Frame: 12 weeks
Changes of insulin from baseline assessed to standard laboratory procedures.
12 weeks
Glycated hemoglobin
Time Frame: 12 weeks
Changes of glycated hemoglobin from baseline assessed to standard laboratory procedures.
12 weeks
HOMA index
Time Frame: 12 weeks
Changes of HOMA index from baseline assessed to standard laboratory procedures.
12 weeks
Total cholesterol
Time Frame: 12 weeks
Changes of total cholesterol from baseline assessed to standard laboratory procedures.
12 weeks
LDL cholesterol
Time Frame: 12 weeks
Changes of LDL cholesterol from baseline assessed to standard laboratory procedures.
12 weeks
HDL cholesterol
Time Frame: 12 weeks
Changes of HDL cholesterol from baseline assessed to standard laboratory procedures.
12 weeks
Triglycerides
Time Frame: 12 weeks
Changes of triglycerides from baseline assessed to standard laboratory procedures.
12 weeks
AST
Time Frame: 12 weeks
Changes of AST from baseline assessed to standard laboratory procedures.
12 weeks
ALT
Time Frame: 12 weeks
Changes of ALT from baseline assessed to standard laboratory procedures.
12 weeks
GGT
Time Frame: 12 weeks
Changes of GGT from baseline assessed to standard laboratory procedures.
12 weeks
hs-CRP
Time Frame: 12 weeks
Changes of hs-CRP from baseline assessed to standard laboratory procedures.
12 weeks
Interleukin 1-alpha
Time Frame: 12 weeks
Changes of interleukin 1-alpha from baseline assessed to standard laboratory procedures.
12 weeks
Interleukin 1-beta
Time Frame: 12 weeks
Changes of interleukin 1-beta from baseline assessed to standard laboratory procedures.
12 weeks
Interleukin 6
Time Frame: 12 weeks
Changes of interleukin 6 from baseline assessed to standard laboratory procedures.
12 weeks
Interleukin 18
Time Frame: 12 weeks
Changes of interleukin 18 from baseline assessed to standard laboratory procedures.
12 weeks
Tumor necrosis factor alpha
Time Frame: 12 weeks
Changes of tumor necrosis factor alpha from baseline assessed to standard laboratory procedures.
12 weeks
Reactive Oxigen Species (ROS)
Time Frame: 12 weeks
Changes of Reactive Oxigen Species (ROS) from baseline assessed to standard laboratory procedures.
12 weeks
Glutathione
Time Frame: 12 weeks
Changes of glutathione from baseline assessed to standard laboratory procedures.
12 weeks
Homocysteine
Time Frame: 12 weeks
Changes of homocysteine from baseline assessed to standard laboratory procedures.
12 weeks
LPS-binding protein
Time Frame: 12 weeks
Changes of LPS-binding protein from baseline assessed to standard laboratory procedures.
12 weeks
Weight
Time Frame: 12 weeks
Changes of body weight from baseline assessed through a balance.
12 weeks
Fat mass
Time Frame: 12 weeks
Changes of fat mass from baseline assessed through a bioelectrical impedance analysis device (Tanita, TBF-410)
12 weeks
Fat-free mass
Time Frame: 12 weeks
Changes of fat-free mass from baseline assessed through a bioelectrical impedance analysis device (Tanita, TBF-410)
12 weeks
Dietary habits
Time Frame: 12 weeks
Changes of dietary habits from baseline assessed through the Medi-Lite score, with a total score ranging from 0 to 18, with higher scores meaning a higher adherence to the Mediterranean diet.
12 weeks
Gastrointestinal and systemic symptoms through the GAI score
Time Frame: 12 weeks
Changes of gastrointestinal and systemic symptoms from baseline assessed through the Global Assessment of Improvement Scale (GAI), with a total score ranging from 0 to 56, with higher scores meaning an improvement of the symptoms
12 weeks
Gastrointestinal and systemic symptoms through the SSS score
Time Frame: 12 weeks
Changes of gastrointestinal and systemic symptoms from baseline assessed through the Symptom Severity Scale (SSS), with a total score ranging from 0 to 500, with higher scores meaning more severe symptoms.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda Ospedaliero-Universitaria Careggi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Francesco Sofi, Prof., Unit of Clinical Nutrition, University Hospital of Careggi Florence, Italy, 50134

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PrOBesity study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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