Biometrical Evaluation of the Efficacy of a Food Supplement Versus Placebo
Finzelberg GmbH & Co. KG
66 participants
Oct 14, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria11
- Phototype: I to IV;
- Subjects with normal to dry skin;
- Subjects with healthy skin on the study area;
- Non-smokers;
- Has normal nutritional habits (not vegetarian/vegan);
- Is not pregnant or lactating;
- Has a BMI of 18 - 33 kg/m2;
- Is willing to refrain from taking dietary supplements (at best not at all, in any case not during the last month before study start);
- Willing not to use any oral products or any nutritional supplementation aiming at improving skin status during the course of the study;
- No history of malabsorption diseases, liver diseases, or diseases of the lipid metabolism;
- Uses no medication, which may interact with the study product
Exclusion Criteria15
- For women: pregnant or nursing woman or woman planning to get pregnant during the study;
- Cutaneous pathology on the study zone (eczema, etc.);
- Subject with make-up on the day of the visit at the laboratory;
- Use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the efficacy of the study product:
- change in anti-wrinkle, smoothing and/or firming topical products within previous week on the studied zones,
- non-invasive procedures within previous month on the studied zones,
- intake of food supplement acting on skin within the three previous months,
- invasive procedures:
- deep chemical peeling within previous 3 months on the studied zones,
- mesotherapy, dermapen, laser within previous 6 months on the studied zones,
- botox and/or hyaluronic acid injections within previous 12 months on the studied zones;
- Intake of vitamin substances and diets comprising a change of normal eating habits;
- Known allergy to one or several investigational product´s ingredients;
- Participation in a nutritional study within the last 30 days;
- Surgical or internal diseases e.g. a metabolic or endocrine disease that may affect the outcome of the study (e.g. diabetes, liver diseases, kidney disorders) or having a history of medical or surgical events that may significantly affect the study outcome including any cardiovascular disease, skin disease, hypertension (>140/90 mm Hg in three repeated measurements).
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Interventions
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)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06727292