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

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: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Dietary supplement: Probiotic; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Waist circumference	Changes of waist circumference from baseline assessed through a metric tape	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiota	Changes of gut microbiota from baseline assessed by NGS technology	12 weeks
Short-chain fatty acids (SCFAs)	Changes of SCFAs from baseline assessed by gas chromatography	12 weeks
Hemoglobin	Changes of hemoglobin from baseline assessed to standard laboratory procedures.	12 weeks
White blood cells	Changes of white blood cells from baseline assessed to standard laboratory procedures.	12 weeks
Red blood cells	Changes of red blood cells from baseline assessed to standard laboratory procedures.	12 weeks
Platelets	Changes of platelets from baseline assessed to standard laboratory procedures.	12 weeks
Glucose	Changes of glucose from baseline assessed to standard laboratory procedures.	12 weeks
Insulin	Changes of insulin from baseline assessed to standard laboratory procedures.	12 weeks
Glycated hemoglobin	Changes of glycated hemoglobin from baseline assessed to standard laboratory procedures.	12 weeks
HOMA index	Changes of HOMA index from baseline assessed to standard laboratory procedures.	12 weeks
Total cholesterol	Changes of total cholesterol from baseline assessed to standard laboratory procedures.	12 weeks
LDL cholesterol	Changes of LDL cholesterol from baseline assessed to standard laboratory procedures.	12 weeks
HDL cholesterol	Changes of HDL cholesterol from baseline assessed to standard laboratory procedures.	12 weeks
Triglycerides	Changes of triglycerides from baseline assessed to standard laboratory procedures.	12 weeks
AST	Changes of AST from baseline assessed to standard laboratory procedures.	12 weeks
ALT	Changes of ALT from baseline assessed to standard laboratory procedures.	12 weeks
GGT	Changes of GGT from baseline assessed to standard laboratory procedures.	12 weeks
hs-CRP	Changes of hs-CRP from baseline assessed to standard laboratory procedures.	12 weeks
Interleukin 1-alpha	Changes of interleukin 1-alpha from baseline assessed to standard laboratory procedures.	12 weeks
Interleukin 1-beta	Changes of interleukin 1-beta from baseline assessed to standard laboratory procedures.	12 weeks
Interleukin 6	Changes of interleukin 6 from baseline assessed to standard laboratory procedures.	12 weeks
Interleukin 18	Changes of interleukin 18 from baseline assessed to standard laboratory procedures.	12 weeks
Tumor necrosis factor alpha	Changes of tumor necrosis factor alpha from baseline assessed to standard laboratory procedures.	12 weeks
Reactive Oxigen Species (ROS)	Changes of Reactive Oxigen Species (ROS) from baseline assessed to standard laboratory procedures.	12 weeks
Glutathione	Changes of glutathione from baseline assessed to standard laboratory procedures.	12 weeks
Homocysteine	Changes of homocysteine from baseline assessed to standard laboratory procedures.	12 weeks
LPS-binding protein	Changes of LPS-binding protein from baseline assessed to standard laboratory procedures.	12 weeks
Weight	Changes of body weight from baseline assessed through a balance.	12 weeks
Fat mass	Changes of fat mass from baseline assessed through a bioelectrical impedance analysis device (Tanita, TBF-410)	12 weeks
Fat-free mass	Changes of fat-free mass from baseline assessed through a bioelectrical impedance analysis device (Tanita, TBF-410)	12 weeks
Dietary habits	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	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	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

• Sponsor: Azienda Ospedaliero-Universitaria Careggi
• Investigators: Principal Investigator: Francesco Sofi, Prof., Unit of Clinical Nutrition, University Hospital of Careggi Florence, Italy, 50134

Publications and helpful links

General Publications

• Borgeraas H, Johnson LK, Skattebu J, Hertel JK, Hjelmesaeth J. Effects of probiotics on body weight, body mass index, fat mass and fat percentage in subjects with overweight or obesity: a systematic review and meta-analysis of randomized controlled trials. Obes Rev. 2018 Feb;19(2):219-232. doi: 10.1111/obr.12626. Epub 2017 Oct 18.
• Chung HJ, Yu JG, Lee IA, Liu MJ, Shen YF, Sharma SP, Jamal MA, Yoo JH, Kim HJ, Hong ST. Intestinal removal of free fatty acids from hosts by Lactobacilli for the treatment of obesity. FEBS Open Bio. 2016 Jan 18;6(1):64-76. doi: 10.1002/2211-5463.12024. eCollection 2016 Jan.
• Gomes AC, de Sousa RG, Botelho PB, Gomes TL, Prada PO, Mota JF. The additional effects of a probiotic mix on abdominal adiposity and antioxidant Status: A double-blind, randomized trial. Obesity (Silver Spring). 2017 Jan;25(1):30-38. doi: 10.1002/oby.21671.
• Fan Y, Pedersen O. Gut microbiota in human metabolic health and disease. Nat Rev Microbiol. 2021 Jan;19(1):55-71. doi: 10.1038/s41579-020-0433-9. Epub 2020 Sep 4.
• Holzapfel W, Arini A, Aeschbacher M, Coppolecchia R, Pot B. Enterococcus faecium SF68 as a model for efficacy and safety evaluation of pharmaceutical probiotics. Benef Microbes. 2018 Apr 25;9(3):375-388. doi: 10.3920/BM2017.0148. Epub 2018 Apr 10.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2024
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: January 25, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 25, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight
• Other Study ID 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