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.

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