Biometrical Evaluation of the Efficacy of a Food Supplement Versus Placebo (FB_BfW)

Finzelberg GmbH & Co. KG

Status: Enrolling

Conditions: Hair Condition; Skin Condition; Skin Aging

Treatments: Dietary Supplement: Food supplement; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06727292

STUX824AA0245

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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66 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

The placebo has similar characteristics as the verum instant drink.

Treatment:

Dietary Supplement: Placebo

Food supplement

Experimental group

Description:

Powder for an instant drink preparation with orange flavor /taste

Treatment:

Dietary Supplement: Food supplement