Overweight and Obesity
Conditions
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.
Interventions
DIETARY_SUPPLEMENTProbiotic
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.
DIETARY_SUPPLEMENTPlacebo
N°1 stick/day of placebo food supplement (i.e., stick without added probiotics), with the same intake modalities as probiotic.
Sponsors
Azienda Ospedaliero-Universitaria Careggi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Waist circumference | 12 weeks | Changes of waist circumference from baseline assessed through a metric tape |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycated hemoglobin | 12 weeks | Changes of glycated hemoglobin from baseline assessed to standard laboratory procedures. |
| Gut microbiota | 12 weeks | Changes of gut microbiota from baseline assessed by NGS technology |
| Short-chain fatty acids (SCFAs) | 12 weeks | Changes of SCFAs from baseline assessed by gas chromatography |
| Hemoglobin | 12 weeks | Changes of hemoglobin from baseline assessed to standard laboratory procedures. |
| White blood cells | 12 weeks | Changes of white blood cells from baseline assessed to standard laboratory procedures. |
| Red blood cells | 12 weeks | Changes of red blood cells from baseline assessed to standard laboratory procedures. |
| Platelets | 12 weeks | Changes of platelets from baseline assessed to standard laboratory procedures. |
| Glucose | 12 weeks | Changes of glucose from baseline assessed to standard laboratory procedures. |
| Insulin | 12 weeks | Changes of insulin from baseline assessed to standard laboratory procedures. |
| Total cholesterol | 12 weeks | Changes of total cholesterol from baseline assessed to standard laboratory procedures. |
| LDL cholesterol | 12 weeks | Changes of LDL cholesterol from baseline assessed to standard laboratory procedures. |
| HDL cholesterol | 12 weeks | Changes of HDL cholesterol from baseline assessed to standard laboratory procedures. |
| Triglycerides | 12 weeks | Changes of triglycerides from baseline assessed to standard laboratory procedures. |
| AST | 12 weeks | Changes of AST from baseline assessed to standard laboratory procedures. |
| ALT | 12 weeks | Changes of ALT from baseline assessed to standard laboratory procedures. |
| GGT | 12 weeks | Changes of GGT from baseline assessed to standard laboratory procedures. |
| HOMA index | 12 weeks | Changes of HOMA index from baseline assessed to standard laboratory procedures. |
| Interleukin 1-alpha | 12 weeks | Changes of interleukin 1-alpha from baseline assessed to standard laboratory procedures. |
| Interleukin 1-beta | 12 weeks | Changes of interleukin 1-beta from baseline assessed to standard laboratory procedures. |
| Interleukin 6 | 12 weeks | Changes of interleukin 6 from baseline assessed to standard laboratory procedures. |
| Interleukin 18 | 12 weeks | Changes of interleukin 18 from baseline assessed to standard laboratory procedures. |
| Tumor necrosis factor alpha | 12 weeks | Changes of tumor necrosis factor alpha from baseline assessed to standard laboratory procedures. |
| Reactive Oxigen Species (ROS) | 12 weeks | Changes of Reactive Oxigen Species (ROS) from baseline assessed to standard laboratory procedures. |
| Glutathione | 12 weeks | Changes of glutathione from baseline assessed to standard laboratory procedures. |
| Homocysteine | 12 weeks | Changes of homocysteine from baseline assessed to standard laboratory procedures. |
| LPS-binding protein | 12 weeks | Changes of LPS-binding protein from baseline assessed to standard laboratory procedures. |
| Weight | 12 weeks | Changes of body weight from baseline assessed through a balance. |
| Fat mass | 12 weeks | Changes of fat mass from baseline assessed through a bioelectrical impedance analysis device (Tanita, TBF-410) |
| Fat-free mass | 12 weeks | Changes of fat-free mass from baseline assessed through a bioelectrical impedance analysis device (Tanita, TBF-410) |
| Dietary habits | 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. |
| Gastrointestinal and systemic symptoms through the GAI score | 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 |
| Gastrointestinal and systemic symptoms through the SSS score | 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. |
| hs-CRP | 12 weeks | Changes of hs-CRP from baseline assessed to standard laboratory procedures. |
Countries
Italy
Outcome results
None listed