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

NACompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

February 20, 2024

Primary Completion Date

September 30, 2024

Study Completion Date

December 31, 2024

Conditions
Overweight and Obesity
Interventions
DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

Placebo

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

Trial Locations (1)

50124

Careggi University Hospital, Florence

All Listed Sponsors
lead

Azienda Ospedaliero-Universitaria Careggi

OTHER

NCT06795607 - Effect of the Probiotic SF68® on Body Composition and Low-to-moderate Cardiovascular Risk | Biotech Hunter | Biotech Hunter