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This goal of this clinical trial is to study the efficacy of collagen supplement on skin moisture and elasticity in middle-aged women of 30-50 years old.
Participants will be assigned two products with and without collagen supplement and use for 2 months, twice a day.
Researchers will compare the two groups whether there are siginificant improvement of skin moisture and elasticity for participants via skin measurement and anaysis system.
This is a two arms, randomized, double-blind controlled trial. Study product plus collagen supplement and placebo product but without collagen will be randomly assigned to 70 eligible participants who will be enrolled at two study sites in Shanghai. Participants need to use the assigned product one bottle (25ml) each time, twice a day and visit the study site for three times (baseline day, day 30 and day 60) during the 2-month study. For each visit, the primary outcomes (skin hydration and skin elasticity) and secondary outcomes (skin barrier, lines/wrinkles, and facial glow,etc.) will be measured with professional equiment and imaging system and recorded to data management system. At the end of the study, the study data will exported and analyzed to validate the assumption that the collagen could improve skin moisture content and elasticity in middle-aged women of 30-50 years old.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WonderLab Collagen Tripeptide Drink | Active Comparator | 25ml/bottle, containing the following ingredients per 25ml serving:
|
|
| Ordinary Drink | Placebo Comparator | 25ml/bottle, containing the following ingredients per 25ml serving:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WonderLab Collagen Tripeptide Drink | Dietary Supplement | the participant in this arm will use the assigned product 25ml one time, twice a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Skin Elasticity | The changes of skin elasticity by CK Cutometer MPA580 | baseline day 0, day 30, day 60 |
| Skin Moisture | The changes of skin moisture by Corneometer CM 825 | baseline day 0, day 30, day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Barrier | The changes of skin barrier in terms of TEWL (Trans Epidermal Water Loss) by Aquaflux F200 | baseline day 0, day 30, day 60 |
| Lines/Wrinkles | The changes of the lines/wrinkles on the face by Miravex Antera 3D imaging system |
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Inclusion Criteria:
Exclusion Criteria:
the participants must be middle-aged women of 30-50 years old
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| Name | Affiliation | Role |
|---|---|---|
| Yun Wang, MD | NO. 9 Hospital affiliated to Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ai'er Hospital | Shanghai | Shanghai Municipality | China | |||
| SPRIM Central Lab |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 21480801 | Background | Zague V, de Freitas V, da Costa Rosa M, de Castro GA, Jaeger RG, Machado-Santelli GM. Collagen hydrolysate intake increases skin collagen expression and suppresses matrix metalloproteinase 2 activity. J Med Food. 2011 Jun;14(6):618-24. doi: 10.1089/jmf.2010.0085. Epub 2011 Apr 11. |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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| Ordinary Drink | Dietary Supplement | the participant in this arm will use the assigned product 25ml one time, twice a day. |
|
| baseline day 0, day 30, day 60 |
| Skin Diagnosis | The skin diagnosis (4 modes and 2 side views) with VISIA CR Facial Imaging System | baseline day 0, day 30, day 60 |
| Shanghai |
| Shanghai Municipality |
| China |
| 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. |
| 16154324 | Background | Nouveau-Richard S, Yang Z, Mac-Mary S, Li L, Bastien P, Tardy I, Bouillon C, Humbert P, de Lacharriere O. Skin ageing: a comparison between Chinese and European populations. A pilot study. J Dermatol Sci. 2005 Dec;40(3):187-93. doi: 10.1016/j.jdermsci.2005.06.006. Epub 2005 Sep 8. |
| 21535500 | Background | Liang J, Pei X, Zhang Z, Wang N, Wang J, Li Y. The protective effects of long-term oral administration of marine collagen hydrolysate from chum salmon on collagen matrix homeostasis in the chronological aged skin of Sprague-Dawley male rats. J Food Sci. 2010 Oct;75(8):H230-8. doi: 10.1111/j.1750-3841.2010.01782.x. Epub 2010 Sep 24. |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |