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NCT Number: 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

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.

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Key information

Age range

35 year–58 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supplementation with Verisol®

Dietary Supplement

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.

Supplementation with Peptech® 2.5G

Dietary Supplement

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.

Supplementation with Peptech® 10.0G

Dietary Supplement

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.

Control group

Diagnostic Test

The control group will not receive supplementation.

Primary outcomes

  1. Plasma levels of Klotho, VEGF, and TGF-beta

    Time frame: Three months.

Study contacts

Contact information is provided by the study sponsor or research team.

Luis Vicente Franco de Oliveira Coordinator of the Stricto Sensu Graduate Program in Human Mov

CONTACT

[email protected]

(62)3310-6736

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 14, 2025
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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