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| Name | Class |
|---|---|
| Tosla d.o.o. | INDUSTRY |
| Slovenian Research Agency | OTHER |
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The aim of the randomized, double-blind, placebo-controlled, one-period effectiveness study is to compare the effects of multiple-dose 12 weeks daily dietary supplementation with 10 g collagen alone or 5 g or 10 g of collagen in combination with MSM on skin in healthy human subjects in comparison to placebo product. The main objective is to show that test products have beneficial effects on dermis density, and also on other skin parameters and to investigate differences in the effects among test products.
This is a double-blind, randomized, placebo-controlled four-way study comparing the efficacy of multiple-dose dietary intake of three test products on skin parameters, that will be conducted in Slovenia in one research center.
The study will be performed on 109 adult women, between the ages 40 and 65 years and will include daily dietary supplementation over 12-weeks period.
Subjects will be divided in four study groups . Test group 1 (TG1) will receive investigational product 1 (IP1, daily dose 25 mL: collagen 5 g, MSM: 1,5 g, vitamin C: 80 mg), test group 2 (TG2) will receive investigational product 2 (IP2, daily dose 25 mL: collagen 10 g, vitamin C: 80 mg), test group 3 (TG3) will receive investigational product 3 (TP3, daily dose 25 mL: collagen 10 g, MSM: 1,5 g, , vitamin C: 80 mg) and the placebo group (PG) will receive placebo product without those active ingredients (25 mL: 0 g collagen, 0 g MSM). Participants will test continuous administration of placebo or investigational products for 12 weeks in order to demonstrate and assess multiple-dose effects. Their influence on skin appendages via self-evaluations questionnaires will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CoMSM LD | Active Comparator | Participants will receive investigational product 1 containing collagen (5 g/ 25 mL), MSM (1.5 g/ 25 mL) and vitamin C (80 mg/ 25 mL). |
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| Placebo group | Placebo Comparator | Placebo group participants will receive placebo syrup without active ingredients. (daily dose 10 mL: fish collagen: 0 mg, vitamin C: 0 mg); continous administration of placebo product for 12 weeks. |
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| Co HD | Active Comparator | Participants will receive investigational product 2 containing collagen (10 g/ 25 mL) and vitamin C (80 mg/ 25 mL). |
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| CoMSM HD | Active Comparator | Participants will receive investigational product 3 containing collagen (10 g/ 25 mL), MSM (1.5 g/ 25 mL) and vitamin C (80 mg/ 25 mL). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational product 1 | Dietary Supplement | Test group 1 will receive investigational product 1 containing collagen (5 g/ 25 mL), MSM (1.5 g/ 25 mL) and vitamin C (80 mg/ 25 mL); continuous administration of investigational product for 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of dermis density from baseline in all test groups in comparison to placebo group after 12 weeks of dietary supplementation | Significant change of dermis density from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation with study product is expected. Dermis density will be assessed through ultrasonographic dermis intensity measurement. Differences in change of dermis density between test groups under primary objective conditions will also be evaluated. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of wrinkle volume from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation | Assessment of the effects of investigational product on periorbital wrinkles after 12 weeks of dietary supplementation will be done using topography measurements. Differences between test groups will also be evaluated. | 12 weeks |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katja Žmitek, PhD | Head of Reasearch Group | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Higher School of Applied Sciences, Institute of Cosmetics | Ljubljana | 1000 | Slovenia |
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| Placebo syrup | Dietary Supplement | Placebo group will receive placebo syrup without active ingredients. (daily dose 25 mL: collagen: 0 mg, MSM: 0 mg, vitamin C: 0 mg; continous administration of placebo product for 12 weeks. |
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| Investigational product 2 | Dietary Supplement | Test group 2 will receive investigational product 2 containing collagen (10 g/ 25 mL) and vitamin C (80 mg/ 25 mL); continuous administration of investigational product for 12 weeks. |
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| Investigational product 3 | Dietary Supplement | Test group 3 will receive investigational product 3 containing collagen (10 g/ 25 mL), MSM (1.5 g/ 25 mL) and vitamin C (80 mg/ 25 mL); continuous administration of investigational product for 12 weeks. |
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| Change of skin texture from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation | For assessments of skin texture topography roughness measurements (Ra, Rq) will be performed. Significant changes from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation is expected. Differences between test groups will also be evaluated. | 12 weeks |
| Change of skin hydration from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation | Assessment of the effects of the investigational product on skin hydration after 12 weeks of dietary supplementation. Skin hydration measurements will be performed using conductance principle. Differences between test groups will also be evaluated. | 12 weeks |
| Change of TEWL from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation | Assessment of the effects of investigational product on transepidermal water loss (TEWL) after 12 weeks of dietary supplementation. TEWL measurements will be performed using open chamber principle.Differences between test groups will also be evaluated. | 12 weeks |
| Change of dermis thickness from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation | Significant change of dermis thickness from baseline in test group, in comparison to placebo group after 12 weeks of dietary supplementation with study product is expected. Dermis density will be assessed using ultrasonography. Differences between test groups will also be evaluated. | 12 weeks |
| Change of skin elasticity from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation | For assessments of elasticity viscoelasticity measurements will be performed. Significant changes from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation is expected. Differences between test groups will also be evaluated. Along viscoelasticity the measurement sinchronosusly gives also retraction and Young modulus values, as well as U-values: Uf (final deformation), Ue (skin exstensibility), Uv (delayed distension), Ur (immediate retraction), Ua (total recovery). R5 (Ur/Ue) parameter will also be calculated. | 12 weeks |