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

Federal University of São Paulo

Status and phase: Begins enrollment this month; Phase 4

Conditions: Growth Factors; Skin Health; Collagen Supplementation

Treatments: Diagnostic Test: Control group; Dietary Supplement: Supplementation with Peptech® 2.5G; Dietary Supplement: Supplementation with Peptech® 10.0G; Dietary Supplement: Supplementation with Verisol®

Study type: Interventional

Funder types: Other

Identifiers

NCT06971029

7.233.377

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 35 to 58 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

150 participants in 4 patient groups

Verisol Collagen 2.5 g/day

Experimental group

Description:

Supplementation with Verisol® collagen will be administered at a dose of 2.5 g/day, diluted in water or water-based juice (300-500 mL), and should be consumed daily, 7 days a week, for 3 months.

Treatment:

Dietary Supplement: Supplementation with Verisol®

Peptech Collagen 2.5 g/day (GCP 2.5)

Experimental group

Description:

Supplementation with Peptech® collagen will be administered at a dose of 2.5 g/day, diluted in water or water-based juice (300-500 mL), and should be consumed daily, 7 days a week, for 3 months.

Treatment:

Dietary Supplement: Supplementation with Peptech® 2.5G

eptech Collagen 10 g/day (GCP 10)

Experimental group

Description:

Supplementation with Peptech® collagen will be administered at a dose of 10.0 g/day, diluted in water or water-based juice (300-500 mL), and should be consumed daily, 7 days a week, for 3 months.

Treatment:

Dietary Supplement: Supplementation with Peptech® 10.0G

Group Control

Other group

Description:

he control group will undergo the tests but will not receive supplementation.

Treatment:

Diagnostic Test: Control group