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| Name | Class |
|---|---|
| GELITA | INDUSTRY |
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The goal of this clinical trial is to evaluate whether daily oral supplementation with 2.5 g of specific bioactive collagen peptides (SCP) can improve skin physiology in healthy adult women aged 35-55 years. The main questions it aims to answer are:
Does SCP supplementation increase skin hydration and barrier function? Does SCP improve skin elasticity, firmness, and collagen content? Does SCP reduce the appearance of periorbital wrinkles and improve overall skin appearance? Researchers will compare SCP supplementation to a placebo (a look-alike substance containing no collagen peptides) to see if SCP supports skin structure and appearance over eight weeks.
Participants will:
Consume one sachet of SCP or placebo daily for eight weeks Attend three study visits at baseline, week 4, and week 8 for facial imaging, instrumental skin measurements, and expert assessments Have objective measures taken, including skin hydration, transepidermal water loss, elasticity, firmness, dermal collagen content, and 3D wrinkle morphology Complete subjective skin assessments rated by trained evaluators using a visual analogue scale Report any adverse events or intolerance reactions at each visit This study is designed to provide an integrated evaluation of multiple skin parameters, including barrier function, biomechanical properties, dermal matrix composition, and wrinkle characteristics, in a single trial. By combining objective and subjective measures, the study aims to generate robust and clinically interpretable evidence for the effects of oral collagen peptide supplementation on skin health.
This clinical trial investigates whether daily oral supplementation with specific bioactive collagen peptides (SCP) can support healthy skin in adult women. Skin aging is a natural process influenced by genetics, hormones, and lifestyle, leading to wrinkles, reduced elasticity, and changes in skin structure. Collagen is a key protein that helps maintain skin strength and elasticity, and its levels decline with age.
The study will evaluate the effects of an 8-week course of SCP supplementation compared to a placebo in healthy women aged 35-55 years. Researchers aim to determine whether oral collagen peptides can improve skin hydration, elasticity, firmness, and overall appearance. This trial combines multiple objective and subjective measures to provide a comprehensive assessment of skin health, offering insights into non-invasive nutritional strategies to maintain skin structure and appearance over time.
The findings from this study are expected to enhance understanding of how collagen peptides affect skin physiology and contribute to evidence-based recommendations for supporting healthy skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Specific Collagen Peptides | Experimental | Participants in this arm receive 2.5 g of specific bioactive collagen peptides (VERISOL®) once daily for 8 weeks. The powder is dissolved in warm water and consumed orally. The supplement contains defined collagen peptides derived from bovine type I collagen, which have been shown to support skin hydration, elasticity, firmness, dermal collagen content, and wrinkle reduction. Participants continue their usual lifestyle habits while taking the supplement. |
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| Maltodextrin | Placebo Comparator | Participants in this arm receive a matching placebo sachet once daily for 8 weeks. The placebo contains plant-derived maltodextrin and is identical in appearance, taste, and texture to the collagen peptide supplement. It is dissolved in warm water and consumed orally. Participants continue their usual lifestyle habits while taking the placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Participants in this arm receive a matching placebo sachet once daily for 8 weeks. The placebo contains plant-derived maltodextrin and is identical in appearance, taste, and texture to the collagen peptide supplement. It is dissolved in warm water and consumed orally. Participants continue their usual lifestyle habits while taking the placebo. |
| Measure | Description | Time Frame |
|---|---|---|
| stratum corneum hydration (SCH) | Stratum corneum hydration (SCH) measures the water content in the outermost layer of the skin, reflecting the skin's ability to retain moisture and maintain a healthy barrier. In this study, SCH is the primary efficacy endpoint, used to compare the effect of daily oral supplementation with specific bioactive collagen peptides (SCP) versus placebo over an 8-week period. SCH is assessed using a Corneometer CM825 at the cheek. Each site is measured six times, and the mean value is used for analysis. Higher SCH values indicate better skin hydration, whereas lower values suggest dryness or impaired barrier function. Changes in SCH over time are compared between the treatment and placebo groups to evaluate the impact of collagen peptide supplementation on skin hydration. | From enrollment to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Transepidermal Water Loss (TEWL) | TEWL measures the rate of water loss through the skin, indicating the integrity of the skin barrier. In this study, TEWL is assessed using the Tewameter TM 300 at the cheek in triplicate, with mean values used for analysis. Higher TEWL values suggest impaired barrier function, while lower values indicate better barrier integrity. Changes over the 8-week supplementation period are compared between the collagen peptide and placebo groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steffen Oesser, Dr | Collagen Research Institute, Schauenburgerstr. 116, D-24118 Kiel | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing EWISH Testing Technology Co., Ltd | Beijing | Haidan | 100142 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30301271 | Background | Vollmer DL, West VA, Lephart ED. Enhancing Skin Health: By Oral Administration of Natural Compounds and Minerals with Implications to the Dermal Microbiome. Int J Mol Sci. 2018 Oct 7;19(10):3059. doi: 10.3390/ijms19103059. | |
| 39150674 | Background | Dahnhardt D, Dahnhardt-Pfeiffer S, Segger D, Poeggeler B, Lemmnitz G. Restoration of the Ultrastructural Integrity of the Dermal Collagen Network by 12-Week Ingestion of Special Collagen Peptides. Dermatol Ther (Heidelb). 2024 Sep;14(9):2509-2521. doi: 10.1007/s13555-024-01251-8. Epub 2024 Aug 16. |
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The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. The data will not be publicly available due to privacy and ethical restrictions.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 10, 2024 | Apr 1, 2026 | Prot_000.pdf |
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|
| Specific Collagen Peptides | Dietary Supplement | Participants in this arm receive 2.5 g of specific bioactive collagen peptides (VERISOL®) once daily for 8 weeks. The powder is dissolved in warm water and consumed orally. The supplement contains defined collagen peptides derived from bovine type I collagen, which have been shown to support skin hydration, elasticity, firmness, dermal collagen content, and wrinkle reduction. Participants continue their usual lifestyle habits while taking the supplement. |
|
| From enrollment to the end of treatment at 8 weeks |
| Skin Elasticity (R2 and R5) and Firmness (F4) | Skin elasticity and firmness are evaluated using the Cutometer MPA580, which applies controlled suction to assess the biomechanical properties of the cheek. R2 (gross elasticity): overall skin elasticity R5 (net elasticity): elastic recovery relative to total deformation F4 (firmness): resistance to deformation Measurements are performed in triplicate and averaged. These parameters provide insight into the skin's structural resilience and are compared between treatment and placebo groups over 8 weeks. | From enrollment to the end of treatment at 8 weeks |
| Dermal collagen content | Dermal collagen content is measured non-invasively using the SIAMETRICS SIAscope V at a 2 mm depth of the cheek. This device quantifies dermal chromophores, including collagen, to assess the integrity and composition of the dermal extracellular matrix. Changes over the 8-week intervention are compared between the SCP and placebo groups. | From enrollment to the end of treatment at 8 weeks |
| Wrinkle Morphology | Wrinkle characteristics around the eyes (area, volume, depth) are measured using the Derma TOP 3D imaging system. | From enrollment to the end of treatment at 8 weeks |
| Skin Appearance (3D Imaging + VAS) | Full-face 2D images are captured with VISIA-CR for additional objective assessments, including spots, skin tone, hydration, and elasticity. Subjective evaluations are performed using a Visual Analogue Scale (VAS) by three trained evaluators, assessing: Smoothness Glossiness Fineness Elasticity Crow's feet and under-eye fine lines VAS scores range from 0 to 10. Higher values indicate better outcomes for attributes such as smoothness, elasticity, and glossiness, while lower values reflect improvement in periorbital wrinkles. Changes over the 8-week supplementation period are compared between treatment and placebo groups. | From enrollment to the end of treatment at 8 weeks |
| 32530124 | Background | Lin P, Alexander RA, Liang CH, Liu C, Lin YH, Lin YH, Chan LP, Kuan CM. Collagen formula with Djulis for improvement of skin hydration, brightness, texture, crow's feet, and collagen content: A double-blind, randomized, placebo-controlled trial. J Cosmet Dermatol. 2021 Jan;20(1):188-194. doi: 10.1111/jocd.13500. Epub 2020 Jun 12. |
| 38892477 | Background | Inacio PAQ, Chaluppe FA, Aguiar GF, Coelho CF, Vieira RP. Effects of Hydrolyzed Collagen as a Dietary Supplement on Fibroblast Activation: A Systematic Review. Nutrients. 2024 May 21;16(11):1543. doi: 10.3390/nu16111543. |
| 38751975 | Background | Dierckx S, Patrizi M, Merino M, Gonzalez S, Mullor JL, Nergiz-Unal R. Collagen peptides affect collagen synthesis and the expression of collagen, elastin, and versican genes in cultured human dermal fibroblasts. Front Med (Lausanne). 2024 May 1;11:1397517. doi: 10.3389/fmed.2024.1397517. eCollection 2024. |
| 28460927 | Background | Fu Y, Young JF, Rasmussen MK, Dalsgaard TK, Lametsch R, Aluko RE, Therkildsen M. Angiotensin I-converting enzyme-inhibitory peptides from bovine collagen: insights into inhibitory mechanism and transepithelial transport. Food Res Int. 2016 Nov;89(Pt 1):373-381. doi: 10.1016/j.foodres.2016.08.037. Epub 2016 Aug 28. |
| 28159262 | Background | Feng M, Betti M. Transepithelial transport efficiency of bovine collagen hydrolysates in a human Caco-2 cell line model. Food Chem. 2017 Jun 1;224:242-250. doi: 10.1016/j.foodchem.2016.12.044. Epub 2016 Dec 18. |
| 29467346 | Background | Osawa Y, Mizushige T, Jinno S, Sugihara F, Inoue N, Tanaka H, Kabuyama Y. Absorption and metabolism of orally administered collagen hydrolysates evaluated by the vascularly perfused rat intestine and liver in situ. Biomed Res. 2018;39(1):1-11. doi: 10.2220/biomedres.39.1. |
| 31497829 | Background | Liu Z, Li Y, Song H, He J, Li G, Zheng Y, Li B. Collagen peptides promote photoaging skin cell repair by activating the TGF-beta/Smad pathway and depressing collagen degradation. Food Funct. 2019 Sep 1;10(9):6121-6134. doi: 10.1039/c9fo00610a. Epub 2019 Sep 9. |
| Background | Wang L, Zhang Y, Zhu Z, Zheng F, Gao R. Food-derived collagen peptides: safety, metabolism, and anti-skin-aging effects. Current Opinion in Food Science. 2023;51:101012. https://doi.org/10.1016/j.cofs.2023.101012. |
| 38612608 | Background | He X, Gao X, Guo Y, Xie W. Research Progress on Bioactive Factors against Skin Aging. Int J Mol Sci. 2024 Mar 28;25(7):3797. doi: 10.3390/ijms25073797. |
| 40761858 | Background | Yang Q, Li H, Zhang H, Ma L, Zhang X, Wu J. Effectiveness of dietary supplements for skin photoaging in healthy adults: a systematic review and meta-analysis of randomized controlled trials. Front Med (Lausanne). 2025 Jul 21;12:1582946. doi: 10.3389/fmed.2025.1582946. eCollection 2025. |
| 34933842 | Background | Michelotti A, Cestone E, De Ponti I, Pisati M, Sparta E, Tursi F. Oral intake of a new full-spectrum hyaluronan improves skin profilometry and ageing: a randomized, double-blind, placebo-controlled clinical trial. Eur J Dermatol. 2021 Dec 1;31(6):798-805. doi: 10.1684/ejd.2021.4176. |
| 36206809 | Background | Morgado-Carrasco D, Gil-Lianes J, Jourdain E, Piquero-Casals J. Oral Supplementation and Systemic Drugs for Skin Aging: A Narrative Review. Actas Dermosifiliogr. 2023 Feb;114(2):114-124. doi: 10.1016/j.ad.2022.09.014. Epub 2022 Oct 4. English, Spanish. |
| 30122200 | Background | Czajka A, Kania EM, Genovese L, Corbo A, Merone G, Luci C, Sibilla S. Daily oral supplementation with collagen peptides combined with vitamins and other bioactive compounds improves skin elasticity and has a beneficial effect on joint and general wellbeing. Nutr Res. 2018 Sep;57:97-108. doi: 10.1016/j.nutres.2018.06.001. Epub 2018 Jun 9. |
| Background | Proksch E, Zdzieblik D, Oesser S. The Oral Intake of Specific Bovine-Derived Bioactive Collagen Peptides Has a Stimulatory Effect on Dermal Matrix Synthesis and Improves Various Clinical Skin Parameters. Cosmetics. 2025;12:79. https://doi.org/10.3390/cosmetics12020079. |
| 24401291 | Background | Proksch E, Schunck M, Zague V, Segger D, Degwert J, Oesser S. Oral intake of specific bioactive collagen peptides reduces skin wrinkles and increases dermal matrix synthesis. Skin Pharmacol Physiol. 2014;27(3):113-9. doi: 10.1159/000355523. Epub 2013 Dec 24. |
| 40518844 | Background | Zague V, Pinheiro ALTA, Pinto JR, Facchini G, Eberlin S. Oral Collagen Oligopeptides as a Modulator of Skin Health: A Comprehensive Evaluation of Clinical and Molecular Effects. J Med Food. 2025 Sep;28(9):869-876. doi: 10.1089/jmf.2024.0252. Epub 2025 Jun 16. |
| 36918892 | Background | Chen CC, Chang SS, Chang CH, Hu CC, Nakao Y, Yong SM, Mandy YLO, Lim CJ, Shim EK, Shih HN. Randomized, double-blind, four-arm pilot study on the effects of chicken essence and type II collagen hydrolysate on joint, bone, and muscle functions. Nutr J. 2023 Mar 15;22(1):17. doi: 10.1186/s12937-023-00837-w. |
| 40935395 | Background | Lee E, Ahn DK, Kim JH, Lee S, Kim HJ, Lee HK, Shin JH. Skin Anti-Aging and Moisturizing Effects of Low-Molecular-Weight Collagen Peptide Supplementation in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. J Microbiol Biotechnol. 2025 Sep 11;35:e2507008. doi: 10.4014/jmb.2507.07008. |
| 23949208 | Background | Proksch E, Segger D, Degwert J, Schunck M, Zague V, Oesser S. Oral supplementation of specific collagen peptides has beneficial effects on human skin physiology: a double-blind, placebo-controlled study. Skin Pharmacol Physiol. 2014;27(1):47-55. doi: 10.1159/000351376. Epub 2013 Aug 14. |
| 33774639 | Background | Miyanaga M, Uchiyama T, Motoyama A, Ochiai N, Ueda O, Ogo M. Oral Supplementation of Collagen Peptides Improves Skin Hydration by Increasing the Natural Moisturizing Factor Content in the Stratum Corneum: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Skin Pharmacol Physiol. 2021;34(3):115-127. doi: 10.1159/000513988. Epub 2021 Mar 26. |
| 26840887 | Background | Inoue N, Sugihara F, Wang X. Ingestion of bioactive collagen hydrolysates enhance facial skin moisture and elasticity and reduce facial ageing signs in a randomised double-blind placebo-controlled clinical study. J Sci Food Agric. 2016 Sep;96(12):4077-81. doi: 10.1002/jsfa.7606. Epub 2016 Feb 10. |
| 36916504 | Background | Lee M, Kim E, Ahn H, Son S, Lee H. Oral intake of collagen peptide NS improves hydration, elasticity, desquamation, and wrinkling in human skin: a randomized, double-blinded, placebo-controlled study. Food Funct. 2023 Apr 3;14(7):3196-3207. doi: 10.1039/d2fo02958h. |
| 29949889 | Background | Kim DU, Chung HC, Choi J, Sakai Y, Lee BY. Oral Intake of Low-Molecular-Weight Collagen Peptide Improves Hydration, Elasticity, and Wrinkling in Human Skin: A Randomized, Double-Blind, Placebo-Controlled Study. Nutrients. 2018 Jun 26;10(7):826. doi: 10.3390/nu10070826. |
| Background | Oesser S, Schunk M, Proksch E. Positive effect of fish-derived Bioactive Collagen Peptides on skin health. International Journal on Nutraceuticals, Functional Foods and Novel Foods. 2020;1:127-33. https://doi.org/10.17470/NF-020-0018. |
| 11333837 | Background | Boelsma E, Hendriks HF, Roza L. Nutritional skin care: health effects of micronutrients and fatty acids. Am J Clin Nutr. 2001 May;73(5):853-64. doi: 10.1093/ajcn/73.5.853. |
| 29455303 | Background | Cole MA, Quan T, Voorhees JJ, Fisher GJ. Extracellular matrix regulation of fibroblast function: redefining our perspective on skin aging. J Cell Commun Signal. 2018 Mar;12(1):35-43. doi: 10.1007/s12079-018-0459-1. Epub 2018 Feb 17. |
| 39336075 | Background | Konstantinou E, Longange E, Kaya G. Mechanisms of Senescence and Anti-Senescence Strategies in the Skin. Biology (Basel). 2024 Aug 23;13(9):647. doi: 10.3390/biology13090647. |
| Background | Burke KE. Environmental aging of the skin: new insights. par. 2020;7:N/A-N/A. https://doi.org/10.20517/2347-9264.2020.154 |
| 34884444 | Background | Csekes E, Rackova L. Skin Aging, Cellular Senescence and Natural Polyphenols. Int J Mol Sci. 2021 Nov 23;22(23):12641. doi: 10.3390/ijms222312641. |
| 31036793 | Background | Shin JW, Kwon SH, Choi JY, Na JI, Huh CH, Choi HR, Park KC. Molecular Mechanisms of Dermal Aging and Antiaging Approaches. Int J Mol Sci. 2019 Apr 29;20(9):2126. doi: 10.3390/ijms20092126. |
| 30190724 | Background | Wang AS, Dreesen O. Biomarkers of Cellular Senescence and Skin Aging. Front Genet. 2018 Aug 23;9:247. doi: 10.3389/fgene.2018.00247. eCollection 2018. |
| 36017417 | Background | Lephart ED, Naftolin F. Factors Influencing Skin Aging and the Important Role of Estrogens and Selective Estrogen Receptor Modulators (SERMs). Clin Cosmet Investig Dermatol. 2022 Aug 19;15:1695-1709. doi: 10.2147/CCID.S333663. eCollection 2022. |
| 39289339 | Background | Zheng Z, Zong Y, Ma Y, Tian Y, Pang Y, Zhang C, Gao J. Glucagon-like peptide-1 receptor: mechanisms and advances in therapy. Signal Transduct Target Ther. 2024 Sep 18;9(1):234. doi: 10.1038/s41392-024-01931-z. |
| 31181682 | Background | Bocheva G, Slominski RM, Slominski AT. Neuroendocrine Aspects of Skin Aging. Int J Mol Sci. 2019 Jun 7;20(11):2798. doi: 10.3390/ijms20112798. |