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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
40
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.
N°1 stick/day of placebo food supplement (i.e., stick without added probiotics), with the same intake modalities as probiotic.
Careggi University Hospital
Florence, Florence, Italy
Waist circumference
Changes of waist circumference from baseline assessed through a metric tape
Time frame: 12 weeks
Gut microbiota
Changes of gut microbiota from baseline assessed by NGS technology
Time frame: 12 weeks
Short-chain fatty acids (SCFAs)
Changes of SCFAs from baseline assessed by gas chromatography
Time frame: 12 weeks
Hemoglobin
Changes of hemoglobin from baseline assessed to standard laboratory procedures.
Time frame: 12 weeks
White blood cells
Changes of white blood cells from baseline assessed to standard laboratory procedures.
Time frame: 12 weeks
Red blood cells
Changes of red blood cells from baseline assessed to standard laboratory procedures.
Time frame: 12 weeks
Platelets
Changes of platelets from baseline assessed to standard laboratory procedures.
Time frame: 12 weeks
Glucose
Changes of glucose from baseline assessed to standard laboratory procedures.
Time frame: 12 weeks
Insulin
Changes of insulin from baseline assessed to standard laboratory procedures.
Time frame: 12 weeks
Glycated hemoglobin
Changes of glycated hemoglobin from baseline assessed to standard laboratory procedures.
Time frame: 12 weeks
HOMA index
Changes of HOMA index from baseline assessed to standard laboratory procedures.
Time frame: 12 weeks
Total cholesterol
Changes of total cholesterol from baseline assessed to standard laboratory procedures.
Time frame: 12 weeks
LDL cholesterol
Changes of LDL cholesterol from baseline assessed to standard laboratory procedures.
Time frame: 12 weeks
HDL cholesterol
Changes of HDL cholesterol from baseline assessed to standard laboratory procedures.
Time frame: 12 weeks
Triglycerides
Changes of triglycerides from baseline assessed to standard laboratory procedures.
Time frame: 12 weeks
AST
Changes of AST from baseline assessed to standard laboratory procedures.
Time frame: 12 weeks
ALT
Changes of ALT from baseline assessed to standard laboratory procedures.
Time frame: 12 weeks
GGT
Changes of GGT from baseline assessed to standard laboratory procedures.
Time frame: 12 weeks
hs-CRP
Changes of hs-CRP from baseline assessed to standard laboratory procedures.
Time frame: 12 weeks
Interleukin 1-alpha
Changes of interleukin 1-alpha from baseline assessed to standard laboratory procedures.
Time frame: 12 weeks
Interleukin 1-beta
Changes of interleukin 1-beta from baseline assessed to standard laboratory procedures.
Time frame: 12 weeks
Interleukin 6
Changes of interleukin 6 from baseline assessed to standard laboratory procedures.
Time frame: 12 weeks
Interleukin 18
Changes of interleukin 18 from baseline assessed to standard laboratory procedures.
Time frame: 12 weeks
Tumor necrosis factor alpha
Changes of tumor necrosis factor alpha from baseline assessed to standard laboratory procedures.
Time frame: 12 weeks
Reactive Oxigen Species (ROS)
Changes of Reactive Oxigen Species (ROS) from baseline assessed to standard laboratory procedures.
Time frame: 12 weeks
Glutathione
Changes of glutathione from baseline assessed to standard laboratory procedures.
Time frame: 12 weeks
Homocysteine
Changes of homocysteine from baseline assessed to standard laboratory procedures.
Time frame: 12 weeks
LPS-binding protein
Changes of LPS-binding protein from baseline assessed to standard laboratory procedures.
Time frame: 12 weeks
Weight
Changes of body weight from baseline assessed through a balance.
Time frame: 12 weeks
Fat mass
Changes of fat mass from baseline assessed through a bioelectrical impedance analysis device (Tanita, TBF-410)
Time frame: 12 weeks
Fat-free mass
Changes of fat-free mass from baseline assessed through a bioelectrical impedance analysis device (Tanita, TBF-410)
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.