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

Официальное название

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

Обзор

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.

Вмешательства

• Пищевая добавка Supplementation with Verisol®
  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.
• Пищевая добавка Supplementation with Peptech® 2.5G
  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.
• Пищевая добавка Supplementation with Peptech® 10.0G
  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.
• Диагностический тест Control group
  The control group will not receive supplementation.

Первичные конечные точки

• Plasma levels of Klotho, VEGF, and TGF-beta [Срок оценки: Three months.]

Критерии участия

Критерии включения

• "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).

Критерии исключения

• "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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 19043850
• Paula-Vieira RHR, Dias SR, Silva-Reis A, Moura-Maia MS, Ramos-Gomes NV, Jesus-Silva K, Oliveira-Leal YR, Castro-Pimentel LT, Carvalho WSF, Melo F, Martins JLR, Bachi ALL, Vieira RP. Immune-Modulatory Effects of Bioactive Collagen Peptides Improve Skin Health in Middle-Aged Women. Dermatol Ther (Heidelb). 2026 Feb;16(2):1385-1397. doi: 10.1007/s13555-026-01654-9. Epub 2026 Jan 27. PMID 41588262

Идентификаторы

NCT: NCT06971029 · 7.233.377

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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