Actively Recruiting
Biometrical Evaluation of the Efficacy of a Food Supplement Versus Placebo
Led by Finzelberg GmbH & Co. KG · Updated on 2024-12-10
66
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
F
Finzelberg GmbH & Co. KG
Lead Sponsor
E
Eurofins
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial investigates whether taking a nutritional supplement daily for two months can improve skin health measures in women aged 45 to 65 years. It is a national, single-center, double-blind, randomized pilot study designed to compare a food supplement against a placebo, with safety overseen by the sponsor. The study focuses on skin aging and hair and skin condition in healthy adult women with normal to dry skin. Participants will receive either a powder food supplement or a matching placebo to dissolve in water, taken once daily for 56 days. The placebo resembles the active supplement in taste and appearance, both provided as orange-flavored instant drinks in sachets. The study includes visits at the start, after 28 days, and after 56 days of supplementation to monitor progress. Throughout the trial, participants will keep a diary to record skin status and any side effects. Researchers will assess skin physiological parameters at baseline, day 28, and day 56. They will also evaluate subject satisfaction, skin and hair quality, and monitor any adverse events during the full study period to understand the supplements effects and tolerability.
CONDITIONS
Brief Title
Biometrical Evaluation of the Efficacy of a Food Supplement Versus Placebo
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 45 to 65 years
- Phototype skin I to IV
- Normal to dry skin with healthy skin on the study area
- Non-smoker
- Normal nutritional habits (not vegetarian or vegan)
- Not pregnant or lactating
- Body mass index (BMI) between 18 and 33 kg/m2
- Willing to avoid dietary supplements before and during the study
- No history of malabsorption, liver, or lipid metabolism diseases
- Not using medications that may interact with the study product
You will not qualify if you...
- Pregnant, nursing, or planning pregnancy during the study
- Skin conditions like eczema on the study area
- Wearing make-up on the day of the laboratory visit
- Recent use of topical or systemic treatments affecting skin assessment (various timing restrictions)
- Recent invasive or non-invasive skin procedures on the study zones
- Intake of vitamin substances or diets changing normal eating habits
- Known allergy to ingredients of the study products
- Participation in another nutritional study within the last 30 days
- Presence of surgical or internal diseases affecting study outcomes, including diabetes, liver or kidney disorders, cardiovascular disease, skin disease, or hypertension above 140/90 mm Hg on repeated measurements
Research Team
C
Cynthia G Suarez, PhD
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