Excessive food cravings Other
Conditions
Interventions
The investigational product is SelectSIEVE®LIBRA, containing 60% Salvia officinalis extract and 40% Morus alba (white mulberry) extract, with maltodextrin and magnesium stearate as excipients.
The pl
Sponsors
ROELMI HPC S.R.L., Via Celeste Milani 24/26 – 21040 Origgio (VA), Italy
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male and female subjects 2. 90% Caucasian subjects; 10% mixed-ethnicity subjects 3. Subjects aged between 18 and 45 years (extremes included) 4. Subjects who are overweight at screening (at the recruitment, BMI between 25 kg/m2 and 29.9 kg/m2 , according to the World Health Organization (WHO) BMI Classification) 5. Subjects with stable body weight at screening, defined as a fluctuation of no more than ±2 kg during the one-month screening phase, with body weight assessed every 14 days 6. Subjects with a stable, light-to-moderate physical activity level (e.g., routine daily mobility such as walking =30 minutes/day or equivalent), not engaged in competitive sports or structured training programs that may significantly influence body weight or body composition, and willing to maintain their habitual activity level throughout the entire study duration 7. Subjects who commit not to change their daily routine throughout the entire study period (screening and experimental phases)* 8. Subjects with self-perceived excessive food craving at screening, defined as a score =6 on a 0–10 Visual Numeric Scale (VNS). 9. Subjects registered with the national public health system in the country where the study is conducted 10. Subjects certifying the truthfulness of the personal data disclosed to the investigator 11. Subjects able to understand the language used in the investigation centre and the information given by the investigator 12. Subjects able to respect the instructions given by the investigator as well as able to respect the study constraints and specific requirements 13. Subjects on stable pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) for at least one month without any changes expected or planned during the study 14. Subjects informed about the test procedures who have signed a consent form and privacy agreement * Subjects will complete a daily food and physical activities diary to monitor their habitual diet and quotidian/physical activity. Diaries will be collected during the one-month screening period and at each month of treatment (T28, T56, and T84).
Exclusion criteria
Exclusion criteria: 1. Subjects who do not meet the inclusion criteria 2. Menopausal or perimenopausal subjects 3. Subjects with any acute, chronic, or progressive disease or condition that may interfere with the study data or that the investigator considers dangerous to the subject or incompatible with the requirements of the study** 4. Subjects currently following a weight-loss diet/program or who started a structured diet/exercise program within the last 3 month 5. Subjects participating or planning to participate in other clinical trials 6. Subjects who participated in a similar study without respecting an adequate washout period (at least one month) 7. Subjects that have food intolerances or food allergies to ingredients of the study product 8. Subjects under pharmacological treatments that are considered incompatible with the study requirement by the investigator *** 9. Subjects who are currently using food supplement(s) and/or products with the same activity as the study product, or who haven't observed an adequate washout period (at least one month) 10. Subjects admitted to a health or social facility 11. Subjects planning a hospitalization during the study 12. Subjects not able to be contacted in case of emergency 13. Subjects deprived of freedom by administrative or legal decision or under guardianship 14. Subjects who have or have had a history of alcohol or drug addiction 15. Subjects with eating disorders (i.e. bulimia, psychogenic eating disorders, etc.) 16. Subjects breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential) ** Including malignancy, severe cardiovascular disease, severe hepatic or renal impairment, neurological or psychiatric disorders, serious infections, autoimmune diseases or any medical condition that may affect body weight, appetite, or eating behavior or any condition considered by the Principal Investigator to interfere with the study. *** Including the use of medications known to affect body weight, appetite, or eating behavior or any medication considered by the Principal Investigator to interfere with the study.
Countries
Italy, Romania
Contacts
Public ContactRoberta Villa
Outcome results
None listed