The purpose of this clinical trial is to evaluate whether nutritional supplementation over a 2-month period improves skin physiological parameters. This is a national, single-center, double-blind, randomized pilot study. The study will be conducted using a supplement and a placebo, the safety of which has been assured by the sponsor. Participants will: * Take a food supplement or a placebo once daily for 2 months * Visit the study center at beginning, after 28 days and after 56 days of supplementation. * Keep a diary of their skin status and tolerability The secondary objective is to evaluate product characteristics and performance during normal use in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
66
Instant drink in a powder form presented in a sachet to be disolved in a glass of water (200 ml).
Instant drink in powder form in a sachet to be disolved in a glass of water (200ml)
Eurofins Dermscan Poland
Gdansk, GDANSK, Poland
RECRUITINGSkin Physiological Parameters
Changes in skin hydration: Measurement of skin hydration by means of a Corneometer CM825.
Time frame: Skin physiological parameters will be assessed at Day 0, Day 28, Day 56
Skin Physiological Parameters
Assessment of skin barrier integrity measuring transepidermal water loss using the Tewameter® TM 300.
Time frame: Skin physiological parameters will be assessed at Day 0, Day 28, Day 56
Skin Physiological Parameters
Change in skin elasticity using Cutometer MPA580
Time frame: Skin physiological parameters will be assessed at Day 0, Day 28, Day 56
Skin Physiological Parameters
Changes in skin density using ultrasound measurements with a frequency of 20 MHz (Derma Scan C, Vers. 3) with 2-D-configuration (Cortex Technology, Denmark).
Time frame: Skin physiological parameters will be assessed at Day 0, Day 28, Day 56
Subject satisfaction
A subjective evaluation questionnaire on the study product's effects on the skin will be completed by subjects (each item is scored individually on a 5 point Likert scale ranging from 'Totally agree' to 'Totally disagree')
Time frame: It will be assessed at Day 28, Day 56
Adverse events
Collection of adverse events throughout the study
Time frame: Adverse events will be assessed during the whole study from Day 0 to Day 56
Subject self-assessment quality of the skin and hair.
The quality of the volunteers' skin and hair will be subjectively assessed by a self-assessment questionnaire. This questionnaire will assess the volunteers' perception of improvement in their skin in general and in wrinkles, spots, redness, elasticity, hydration, appearance. In the case of hair, the questionnaire will assess if it is stronger than before. There will be 5 levels in the questionnaire to assess how true the statements are: No Information (0), No improvement (1), Somewhat (2), Clearly Yes (3) and Yes, Very clearly (4).
Time frame: It will be assessed at Day 28, Day 56
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