Biometrical Evaluation of the Efficacy of a Food Supplement Versus Placebo

NCT ID: NCT06727292

Last Updated: 2024-12-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-14
• Study Completion Date: 2025-05-30

Brief 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.

Conditions

Skin Aging; Hair Condition; Skin Condition

Keywords

improvements of skin physiological parameters

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

The placebo has similar characteristics as the verum instant drink.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Instant drink in powder form in a sachet to be disolved in a glass of water (200ml)

Food supplement

Powder for an instant drink preparation with orange flavor /taste

Group Type: EXPERIMENTAL

Food supplement

Intervention Type: DIETARY_SUPPLEMENT

Instant drink in a powder form presented in a sachet to be disolved in a glass of water (200 ml).

Interventions

Food supplement

Instant drink in a powder form presented in a sachet to be disolved in a glass of water (200 ml).

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Instant drink in powder form in a sachet to be disolved in a glass of water (200ml)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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).

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eurofins

INDUSTRY

Sponsor Role: collaborator

Eurofins Dermscan Pharmascan

INDUSTRY

Sponsor Role: collaborator

Finzelberg GmbH & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eurofins Dermscan Poland

Gdansk, GDANSK, Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Cynthia G Suarez, PhD

Role: CONTACT

Phone: 004916098144462

Email: cynthia.suarez-rizzo@finzelberg.com

Facility Contacts

Maja Kreyzmon, Project manager

Role: primary

Maja KREZYMON

Role: backup

Other Identifiers

STUX824AA0245

Identifier Type: -

Identifier Source: org_study_id