Healthy adult subjects with leg discomfort (tiredness and heaviness) and telangiectasia (CEAP classification: 0-1) Circulatory System
Conditions
Interventions
Participants are randomized (1:1) to either the active or the placebo group using a computer-generated randomization list (PASS 11, version 11.0.8, PASS, LLC. Kaysville, UT, USA).
Treatment consists
Sponsors
Giellepi S.p.A.
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Male and female, adult subjects (18-60 years old included) 2. Healthy subject with BMI <30 kg/m2 3. Subjects with healthy skin 4. Subject presenting telangiectasia at the level of at least one leg and perceiving one or more of the following discomforts: tired legs, heavy legs, swollen legs, leg pain, cramping, itching or tingling in the calves 5. Subjects having signed a written Informed Consent form (ICF) for his/her participation in the study and a photograph authorization 6. Subject able to understand the language used in the investigation center and the information given 7. Subject able to comply with the protocol and follow protocol’s constraints and specific requirements 8. For women of childbearing potential: committing to use effective contraceptive method for at least 3 months before the beginning of the study and throughout the study 9. Subject who agrees not to have any body care procedure done during the study at the level of the legs as well as systemic therapy able to affect the blood circulation 10. Subject who agrees not to expose himself/herself to the sun or UV rays during this study and willing to follow recommendations for photoprotection (use of his/her usual sunscreen product if needed).
Exclusion criteria
Exclusion criteria: 1. Subject having participated in another clinical trial within 30 days before the inclusion visit and for a longer period if required in the Investigator’s opinion 2. Subject taking part or planning to participate in another clinical trial during the study in the same or another investigation centre 3. Subject consuming blood flow-enhancing supplements (e.g. citrulline, arginine, beetroot powder) or functional drinks (e.g. pomegranate or beetroot juice) within 1 month prior to participation 4. Breastfeeding or pregnant (for the women of childbearing potential) 5. Subject deprived of freedom by administrative or legal decision or under guardianship 6. Subject not able to be contacted in case of emergency 7. Subject admitted in a sanitary or social facilities 8. Subject planning a hospitalization or surgery during the study 9. Subjects presenting CVI = or > C2 grade on the Clinical-Etiology-Anatomy-Pathophysiology (CEAP) 10. Cutaneous pathology on the studied zone liable to interfere with the data of the study 11. Acute, chronic or progressive illness, liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements 12. Subject having personal medical history liable to interfere with the study data for the subject or incompatible with the study requirements 13. Subject with vascular diseases different from telangectasia, diabetes, or blood disorders 14. Subject presenting lower limb edema due to cardiac, renal, or hepatic origin 15. Subjects with lower limb arterial disease 16. Subject presenting metabolic, neurological, or orthopedic problems, including traumas and prior amputation, arthritis, neuropathy, or other conditions such as recent vein surgery, or deep or superficial venous thrombosis of the lower limbs during the previous 6 months 17. Hypersensitivity to active principles contained in the tested dietary supplement 18. Smoker (=10 cigarettes/day) 19. Concomitant or previous history of addiction to alcohol, excessive use of spices, or drug abuse 20. Exposure of the study areas to artificial UV or excessive exposure to natural sunlight within the 1 month before the inclusion visit (in the Investigator’s opinion) or planning exposure during the study 21. Application of any cosmetic leave-on product on the study areas on the day of the visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Leg discomfort (including tired and heavy legs) measured using visual analogue score (VAS) at each visit (baseline, day 14, day 28, day 56) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Appearence of telangiectsasia assessed by a dermatologist using an arbitrary scale where 0 indicates absence, 1 very mild, 2 mild, 3 moderate, and 4 severe. This is assessed at each visit (baseline, day 14, day 28, day 56) 2. Blood flow rate is measured using a laser doppler (PeriFlux 6000, Perimed Italia Srl, Cuggiono, Milan, Italy) at each visit (baseline, day 14, day 28, day 56) 3. Skin color, which is related to the hemoglobin content in the superficial microvessels, is measured using a colorimeter (Mexameter® MX18, Courage + Khazaka electronic GmbH, Köln, Germany) at each visit (baseline, day 14, day 28, day 56) 4. Quality of life is assessed using the CIVQ20 questionnaire at baseline and at the end of the study (day 56) 5. The perceived efficacy (as perceived by each participant) is assessed using a 5-point scale (strongly disagree or not satisfied at all, disagree or not satisfied, neither disagree nor agree or neither dissatisfied nor satisfied, agree or satisfied, completely agree or very satisfied) at baseline and at the end of the study (day 56) | — |
Countries
Italy
Contacts
Public ContactVincenzo Nobile
Outcome results
None listed