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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-20

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Probiotic Influence on Obesity-Related Lipidemia

NCT06305650

Overweight or Obesity

COMPLETED NA

EXploratory Study on Postprandial Energy Metabolism

NCT06786052

Obesity and Overweight Moderately Obese

RECRUITING PHASE2

Study on the Weight Loss Effects and Mechanisms of Probiotic Preparation Intervention in Weight Cyclers

NCT07031596

Obesity and Obesity-related Medical Conditions

NOT_YET_RECRUITING NA

Targeting Obesity With the Probiotic Lactiplantibacillus Plantarum IMC 510 (PRO-Weight-Control Study)

NCT05358301

Obesity

COMPLETED NA

Effect of Probiotics Among Overweight and Obese Saudi Adults

NCT05667038

Obesity Adult

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Overweight and Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Probiotic

Probiotic food supplement produced by Cerbios-Pharma SA

Group Type EXPERIMENTAL

Probiotic

Intervention Type DIETARY_SUPPLEMENT

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.

Placebo

Placebo food supplement

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

N°1 stick/day of placebo food supplement (i.e., stick without added probiotics), with the same intake modalities as probiotic.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Probiotic

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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

N°1 stick/day of placebo food supplement (i.e., stick without added probiotics), with the same intake modalities as probiotic.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No