Clinical trial NCT06971029: IMPACT OF SUPPLEMENTATION WITH LOW MOLECULAR WEIGHT HYDROLYZED COLLAGEN AND VERISOL ON THE EXPRESSION OF LINES, SKIN QUALITY, AND LEVELS OF KLOTHO, VEGF, AND TGF-BETA IN THE EYE REGION
Official title: Effects Of Supplementation With New Technology for Obtaining Low Molecular Weight Hydrolyzed Collagen Vs. Verisol Collagen on Expression Lines, Skin Quality in the Orbicularis Oculi Region, And Serum Levels of Klotho, VEGF, and TGF-Beta
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Skin Health
Collagen Supplementation
Growth Factors
Keywords: Skin health
collagen supplementation
growth factors
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 150
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The 150 volunteers will be randomized into three groups (n = 50/group): Verisol Collagen 2.5 g/day (GCV), Peptech Collagen 2.5 g/day (GCP 2.5), and Peptech Collagen 10 g/day (GCP 10).
Primary purpose: PREVENTION

Brief summary: Skin is the largest organ of the human body and performs various vital functions, including protection against external agents, regulation of body temperature, and sensory perception. As we age, our skin undergoes a series of changes that can be noticeable both visually and physically. One of the most evident changes is the appearance of wrinkles and fine lines, resulting from decreased skin elasticity and reduced production of collagen and elastin. Nutrition plays a key role in skin health, influencing its structure, function, and ability to defend against damage and diseases. However, it is unknown to what extent supplementation with different types of collagens can attenuate these effects in middle-aged women. Therefore, the present study aims to recruit 150 middle-aged women (35-58 years old) who will be randomized into three groups, Verisol Collagen 2.5 g/day, Peptech Collagen 2.5 g/day, and Peptech Collagen 10 g/day, 7 days a week, for 3 months. Skin hydration, oiliness, and flexibility, as well as the number and depth of expression lines, will be evaluated, along with plasma levels of Klotho, VEGF, and TGF-beta. Data will be analyzed, and graphs constructed using GraphPad Prism 5.0 software (California, USA). The normality distribution of the data will be assessed by the Kolmogorov-Smirnov test. Data with parametric distribution will be subjected to paired Student's t-test for intragroup comparison, and unpaired t-test will be used for comparison between groups. Significance levels will be considered statistically different for p\<0.05.


Eligibility criteria: Inclusion Criteria:

* "Inclusion criteria require that volunteers be between 35 and 58 years old, have been sedentary for at least one year, and, after reading and understanding all stages of the study, agree to and sign the informed consent form (ICF).

Exclusion Criteria:

* "Exclusion criteria include undergoing facial aesthetic procedures involving hyaluronic acid or botulinum toxin, being an active or passive smoker within the past 3 years, using protein- or amino acid-based supplements within the past 6 months, or using cosmetics with skin-repairing properties in the orbicularis oculi region.

Primary outcomes:
measure: Plasma levels of Klotho, VEGF, and TGF-beta
timeFrame: Three months.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Proksch E, Brandner JM, Jensen JM. The skin: an indispensable barrier. Exp Dermatol. 2008 Dec;17(12):1063-72. doi: 10.1111/j.1600-0625.2008.00786.x.