Overweight female subjects with moderate cellulite on thighs and buttocks Skin and Connective Tissue Diseases
Conditions
Interventions
The product under investigation is Celluvine™, a food supplement that contains ingredients with antioxidant and skin-supporting activity. Half of the recruited subjects are randomized to receive the a
Sponsors
Activ’Inside
Eligibility
Sex/Gender
Female
Age
25 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy female subjects 2. Subjects of Caucasian ethnicity 3. Subjects aged between 25 and 45 years (extremes included) 4. Subjects who are overweight* 5. Subjects with moderate cellulite on thighs and buttocks** 6. Subjects registered with National Health Service (NHS) 7. Subjects certifying the truthfulness of the personal data disclosed to the Principal Investigator or designated personnel 8. Subjects able to understand the language used in the investigation centre and the information given by the investigator or designated personnel 9. Subjects able to respect the instructions given by the investigator or designated personnel as well as able to respect the study constraints and specific requirements 10. Subject who commit not to change their daily routine or lifestyle during the study 11. Subject who commit to follow a normocaloric diet developed by a professional dietitian*** 12. 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 13. Subjects informed about the test procedures who have signed a consent form and privacy agreement * BMI between 25 kg/m2 and 29.9 kg/m2. According to the World Health Organization (WHO) BMI Classification. ** At recruitment, Hexsel Cellulite Severity Scale (CSS) scores from 6 to 10. *** Subjects will adhere to a controlled normocaloric dietary regimen starting two months prior to product intake. Each participant will undergo a visit with a qualified dietitian, who will design a personalized daily diet plan based on the individual’s estimated energy requirements. The prescribed diet will be individualized to ensure energy balance, without inducing weight loss or gain, in order to control for potential confounding effects of caloric intake on study outcomes. Throughout the study, participants will keep a weekly diary to record their dietary adherence (i.e., whether they followed the assigned plan or made any changes) as well as their physical activity
Exclusion criteria
Exclusion criteria: 1. Subjects who do not meet the inclusion criteria 2. Subjects who are menopausal or perimenopausal 3. Subjects who are smokers 4. 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 **** 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. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential). **** Steroids including topical steroids, cytostatics, vasodilators, diuretics, anticoagulants, chemotherapeutics, drugs for obesity; biological drugs; immunosuppressants. ***** chronic disease (blood circulation, cardio-vascular, diabetes, lipedema, psychiatric, neuro-degenerative, cancer, liver, gastric, skin, etc.); favism; history of bariatric surgery (gastric bypass, sleeve gastrectomy, gastric band and duodenal switch.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Hexsel Cellulite Severity Scale (CSS) (score from 1 to 15) at baseline, and after 56 days and 84 days of treatment 2. Cellulite-induced alteration of skin microcirculation (score from 0 to 3) at baseline, and after 56 days and 84 days of treatment 3. Blood flow rate (P.U.) measured using the laser Doppler technique with the Periflux 6000 device (Perimed) at baseline and after 84 days of treatment 4. Maximum height of waviness of skin surface profile (µm) measured using PRIMOS-CR® at baseline and after 84 days of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Waist circumference (cm) measured using a tape at baseline, and after 56 days and 84 days of treatment 2. Hip circumference (cm) measured using a tape at baseline, and after 56 days and 84 days of treatment 3. Thigh circumference (cm) measured using a tape at baseline, and after 56 days and 84 days of treatment 4. Body weight (kg) measured using a scale at baseline and after 84 days of treatment 5. Body Mass Index (BMI) (kg/m²) calculated as BMI = weight (kg) / height² (m²) at baseline and after 84 days of treatment 6. Fat mass (kg) measured using the BIA 101 ASE device (Bioelectrical Impedance Analysis) at baseline and after 84 days of treatment 7. Self-evaluation questionnaire: consists of 12 multiple-choice questions assessing perceived efficacy and product pleasantness, administered after 84 days of treatment | — |
Countries
Italy
Contacts
Public ContactRoberta Villa
Outcome results
None listed