Evaluation of the Anti-aging Efficacy of Two Dietary Supplements
- Conditions
- Healthy Volunteers
- Interventions
- Dietary Supplement: Berry extract 2Dietary Supplement: PlaceboDietary Supplement: Berry extract 1
- Registration Number
- NCT06032598
- Lead Sponsor
- Seppic
- Brief Summary
The study is aimed to assess the efficacy of two dietary supplements composed of berry extracts in reducing skin aging signs and improving skin complexion.
- Detailed Description
A double blind, parallel groups, placebo-controlled study is carried out on 90 healthy female subjects aged between 35 and 65 (±2) years old with phototypes from I to III, uneven skin tone, visible Crow's feet wrinkles and mild-moderate skin slackness at cheek level.
The study foresees 84 days of products intake. Evaluations of the parameters under study are performed at baseline, after 28, 56 and 84 days of products consumption.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 99
Not provided
- Subject does not meet the inclusion criteria,
- Subjects with acute or chronic diseases able to interfere with the outcome of the study or that are considered dangerous for the subject or incompatible with the study requirements
- Subjects participating or planning to participate in other clinical trials
- Subjects deprived of freedom by administrative or legal decision or under guardianship
- Subjects not able to be contacted in case of emergency
- Subjects admitted to a health or social facility
- Subjects planning a hospitalisation during the study
- Subjects who participated in a similar study without respecting an adequate washout period
- Subjects having an 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
- Subjects under pharmacological treatments that are considered incompatible with the study requirement by the investigator
- Subjects having a skin disease or condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
- Subject with known or suspected sensitization to one or more test formulation ingredients
- Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential)
- Consumption of food supplement(s) and/or use of topical skincare products with whitening activity currently or within the past 4 weeks before the study
- Subjects accustomed to use tanning beds
- Subjects taking medication with photosensitizing potential, drugs and/or dietary supplements able to induce skin coloring, corticoids, currently or during the month before the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Berry extract 2 Berry extract 2 Dietary supplement - Berry extract 2 Placebo Placebo Dietary supplement - Placebo Berry extract 1 Berry extract 1 Dietary supplement - Berry extract 1
- Primary Outcome Measures
Name Time Method Skin profilometry 84 days Primos 3D
- Secondary Outcome Measures
Name Time Method Skin elasticity 84 days Cutometer
Skin homogeneity improvment from baseline 84 days Clinical scoring (internal validated scale from 1 to 4, where: 1 = no variation and 4 = evident variation)
Self-assessment of product efficacy 84 days Questionnaire (20 questions with 4 possible answers : completely agree / agree / disagree / completely disagree)
Skin firmness 84 days Clinical scoring (internal validated scale from 1 to 5, where: 1 = not firm skin and 5 = very firm skin)
Skin color 84 days CIELab color space
Crow's feet 84 days Clinical evaluation (Skin Aging Atlas - Caucasian and Asian Type - Bazin Roland)
Skin antioxidant potential 84 days FRAP (Ferric Reducing Antioxidant Power) assay
Trial Locations
- Locations (1)
Complife Italia srl
🇮🇹Milano, Italy