Clinical trial NCT06795607: Effect of the Probiotic SF68® on Body Composition and Low-to-moderate Cardiovascular Risk
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
First posted: 2025-01-28
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
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Waist circumference
timeFrame: 12 weeks
Secondary outcomes:
measure: Gut microbiota
timeFrame: 12 weeks
measure: Short-chain fatty acids (SCFAs)
timeFrame: 12 weeks
measure: Hemoglobin
timeFrame: 12 weeks
measure: White blood cells
timeFrame: 12 weeks
measure: Red blood cells
timeFrame: 12 weeks
measure: Platelets
timeFrame: 12 weeks
measure: Glucose
timeFrame: 12 weeks
measure: Insulin
timeFrame: 12 weeks
measure: Glycated hemoglobin
timeFrame: 12 weeks
measure: HOMA index
timeFrame: 12 weeks
measure: Total cholesterol
timeFrame: 12 weeks
measure: LDL cholesterol
timeFrame: 12 weeks
measure: HDL cholesterol
timeFrame: 12 weeks
measure: Triglycerides
timeFrame: 12 weeks
measure: AST
timeFrame: 12 weeks
measure: ALT
timeFrame: 12 weeks
measure: GGT
timeFrame: 12 weeks
measure: hs-CRP
timeFrame: 12 weeks
measure: Interleukin 1-alpha
timeFrame: 12 weeks
measure: Interleukin 1-beta
timeFrame: 12 weeks
measure: Interleukin 6
timeFrame: 12 weeks
measure: Interleukin 18
timeFrame: 12 weeks
measure: Tumor necrosis factor alpha
timeFrame: 12 weeks
measure: Reactive Oxigen Species (ROS)
timeFrame: 12 weeks
measure: Glutathione
timeFrame: 12 weeks
measure: Homocysteine
timeFrame: 12 weeks
measure: LPS-binding protein
timeFrame: 12 weeks
measure: Weight
timeFrame: 12 weeks
measure: Fat mass
timeFrame: 12 weeks
measure: Fat-free mass
timeFrame: 12 weeks
measure: Dietary habits
timeFrame: 12 weeks
measure: Gastrointestinal and systemic symptoms through the GAI score
timeFrame: 12 weeks
measure: Gastrointestinal and systemic symptoms through the SSS score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Careggi University Hospital
Study officials:
affiliation: Unit of Clinical Nutrition, University Hospital of Careggi Florence, Italy, 50134
name: Francesco Sofi, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.