The effect of a food supplement based on a mixture of herbal extracts on cellulite and weight control

Not Applicable

Completed

• Conditions: Cellulite-derived skin imperfections and localised adiposity at level of thighs/hip/waistline; Nutritional, Metabolic, Endocrine; Cellulite and localised adiposity

• Registration Number: ISRCTN87607337
• Lead Sponsor: ROELMI HPC Srl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-04-03
• Study Start: 2018-07-24
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

1. Good general health
2. Female
3. Caucasian ethnicity
4. Age between 18 and 55 years old
5. Mild to moderate cellulite-derived skin imperfections (grade II and III of the cellulite thermographic stage)
6. BMI between 23 and 30.
7. Not been recently involved in any other similar study
8. Willing to follow the proposed alimentary diet for all the study time
9. Willing to use only the cream consigned at the beginning of the study for body care
10. Willing to submit to before and after pictures
11. Willing to use only the food supplement during the entire study period
12. Willing to not use products likely to interfere with the food supplement
13. Willing to not vary the normal daily routine (i.e. lifestyle, physical activity, etc.)
14. Under effective contraception (oral/not oral) that is not expected to be changed during the trial
15. Aware of study procedures and signed informed consent form

Exclusion Criteria

1. Pregnant or intending to become pregnant during study
2. Breastfeeding
3. Atopy (if this interferes with the study)
4. Allergic to ingredients of food supplements
5. Allergies to cosmetic products, toiletries, sunscreens and/or topical drugs
6. Following anti-cellulite treatment or have followed an anti-cellulite treatment less than 3 months before the study
7. Used sunbeds or self-tanning product for one month before study or intend to use it during the study
8. Using pharmacological treatment (local or systemic) that may interfere with study
9. Intending to initiate any intensive sport
10. Other diseases that may affect outcome of study, especially metabolic or endocrine (e.g. diabetes, liver disease, kidney disorders) or any other condition that the principal investigator deems inappropriate for participation
11. Protected by the law (under guardianship, hospitalised in a public or private institution or incarcerated)
12. Unable to communicate or cooperate with the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> The following outcomes were measured at day 0 (beginning of the treatment), day 28 and day 56 of treatment:<br> 1. Cellulite-induced alteration of the skin microcirculation, measured by thermographic imaging<br> 2. Clinical-dermatological evaluation of the cellulite-derived skin imperfections (Orange peel skin appearance ) carried out by a dermatologist in accordance to clinical scores<br> 3. Thickness of the subcutaneous fatty layer measured by an ultrasound technique (using BX2000 BodyMetrix)<br> 4. Skin elasticity and firmness, measured on the thighs by a Cutometer®<br>

Secondary Outcome Measures

Name	Time	Method
<br> The following outcomes were measured at day 0 (beginning of the treatment), day 28 and day 56 of treatment:<br> 1. Body weight by electric balance and height by stadiometer (for BMI determination)<br> 2. Body circumferences (tights, hips, waistline) by a flexible meter<br> 3. Evaluation of safety (adverse effects and tolerability) by monitoring adverse effects<br><br> 4. Self-assessment evaluation, assessed using a 12 question questionnaire carried out after 28 and 56 days of treatment<br><br>