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

NCT06795607 | Completed

• 1 other identifier: PrOBesity study
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Waist circumference

  Changes of waist circumference from baseline assessed through a metric tape

  12 weeks

Secondary Outcomes (33)

• Gut microbiota

  12 weeks

• Short-chain fatty acids (SCFAs)

  12 weeks

• Hemoglobin

  12 weeks

• White blood cells

  12 weeks

• Red blood cells

  12 weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

Probiotic food supplement produced by Cerbios-Pharma SA

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Placebo food supplement

Dietary Supplement: Placebo

Interventions

Probiotic 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.

Probiotic

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Circulating levels of total cholesterol \>190 mg/dL, not on drug treatment
• Circulating levels of LDL cholesterol \>115 mg/dL, not on drug treatment
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

Study Sites (1)

Careggi University Hospital

Florence, Florence, 50124, Italy

Location

Related Publications (5)

• Borgeraas H, Johnson LK, Skattebu J, Hertel JK, Hjelmesaeth J. Effects of probiotics on body weight, body mass index, fat mass and fat percentage in subjects with overweight or obesity: a systematic review and meta-analysis of randomized controlled trials. Obes Rev. 2018 Feb;19(2):219-232. doi: 10.1111/obr.12626. Epub 2017 Oct 18.

  PMID: 29047207 BACKGROUND

• Chung HJ, Yu JG, Lee IA, Liu MJ, Shen YF, Sharma SP, Jamal MA, Yoo JH, Kim HJ, Hong ST. Intestinal removal of free fatty acids from hosts by Lactobacilli for the treatment of obesity. FEBS Open Bio. 2016 Jan 18;6(1):64-76. doi: 10.1002/2211-5463.12024. eCollection 2016 Jan.

  PMID: 27047743 BACKGROUND

• Fan Y, Pedersen O. Gut microbiota in human metabolic health and disease. Nat Rev Microbiol. 2021 Jan;19(1):55-71. doi: 10.1038/s41579-020-0433-9. Epub 2020 Sep 4.

  PMID: 32887946 BACKGROUND

• Gomes AC, de Sousa RG, Botelho PB, Gomes TL, Prada PO, Mota JF. The additional effects of a probiotic mix on abdominal adiposity and antioxidant Status: A double-blind, randomized trial. Obesity (Silver Spring). 2017 Jan;25(1):30-38. doi: 10.1002/oby.21671.

  PMID: 28008750 BACKGROUND

• Holzapfel W, Arini A, Aeschbacher M, Coppolecchia R, Pot B. Enterococcus faecium SF68 as a model for efficacy and safety evaluation of pharmaceutical probiotics. Benef Microbes. 2018 Apr 25;9(3):375-388. doi: 10.3920/BM2017.0148. Epub 2018 Apr 10.

  PMID: 29633645 BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Francesco Sofi, Prof.

  Unit of Clinical Nutrition, University Hospital of Careggi Florence, Italy, 50134

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Nutrition

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 28, 2025
• Study Start: February 20, 2024
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)