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

Not Applicable

Completed

• Conditions: Overweight and Obesity

• Registration Number: NCT06795607
• Lead Sponsor: Azienda Ospedaliero-Universitaria Careggi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-20
• Primary Completion: 2024-09-30
• Study Completion: 2024-12-31
• Status Verified: 2025-01
• Study First Submitted: 2025-01-21
• Study First Submitted QC: 2025-01-25
• Last Update Submitted: 2025-01-25
• Study First Posted: 2025-01-28
• Last Update Posted: 2025-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Waist circumference	12 weeks	Changes of waist circumference from baseline assessed through a metric tape

Secondary Outcome Measures

Name	Time	Method
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.
HOMA index	12 weeks	Changes of HOMA index from baseline assessed to standard laboratory procedures.
Glycated hemoglobin	12 weeks	Changes of glycated hemoglobin 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.
Tumor necrosis factor alpha	12 weeks	Changes of tumor necrosis factor alpha from baseline assessed to standard laboratory procedures.
hs-CRP	12 weeks	Changes of hs-CRP 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.
Reactive Oxigen Species (ROS)	12 weeks	Changes of Reactive Oxigen Species (ROS) 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.
Glutathione	12 weeks	Changes of glutathione 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.

Trial Locations

Locations (1)

Careggi University Hospital; 🇮🇹 Florence, Italy