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| Name | Class |
|---|---|
| European Regional Development Fund | OTHER |
| Valens Int. d.o.o., Slovenija | INDUSTRY |
| Ministry of Higher Education, Science and Technology, Solvenia | OTHER_GOV |
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Placebo controlled double-blind multi-dose comparative study of the effects of coenzyme Q10 and collagen formulation with improved water-solubility in healthy adults.
One group (test group) will receive investigational product - test syrup (daily dose 10 mL: fish collagen: 4000 mg, water soluble CoQ10 (Q10Vital®): 50 mg, vitamin C: 80 mg, vitamin A: 920 μg, biotin: 150 μg) and the other (placebo group) placebo syrup without those active ingredients. Participants will test continuous administration of placebo or investigational product for 12 weeks in order to demonstrate and assess multiple-dose effects on skin condition and signs of skin aging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Active Comparator | Participants will receive investigational product - Test syrup containing CoQ10 and collagen (daily dose 10 mL: fish collagen (Peptan®): 4000 mg, water soluble CoQ10 (Q10Vital®): 50 mg, vitamin C: 80 mg, vitamin A: 920 μg, biotin: 150 μg). |
|
| Placebo group | Placebo Comparator | Placebo group participants will receive placebo syrup without active ingredients. (daily dose 10 mL: fish collagen: 0 mg, water soluble CoQ10 (Q10Vital®): 0 mg, vitamin C: 0 mg, vitamin A: 0 μg, biotin: 0 μg); continous administration of placebo product for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test syrup containing CoQ10 and collagen | Dietary Supplement | Test group will receive investigational product - test syrup (daily dose 10 mL: fish collagen: 4000 mg, water soluble CoQ10 (Q10Vital®): 50 mg, vitamin C: 80 mg, vitamin A: 920 μg, biotin: 150 μg); continuous administration of investigational product for 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Influence of investigational product in relation to placebo product on dermis density assessed through dermis intensity measurement | Significant change of dermis density 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 through ultrasonographic dermis intensity measurement. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Influence of the investigational product in relation to placebo product on skin elasticity assessed through measurements of viscoelasticity | For assessments of skin viscoelasticity measurements will be performed. Significant change of skin viscoeasticity from baseline in test group, in comparison to placebo group after 12 weeks of dietary supplementation with study product is expected. | 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 10 mL: fish collagen: 0 mg, water soluble CoQ10 (Q10Vital®): 0 mg, vitamin C: 0 mg, vitamin A: 0 μg, biotin: 0 μg); continous administration of placebo product for 12 weeks. |
|
| Influence of the investigational product in relation to placebo product on skin hydration | 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. | 12 weeks |
| Influence of the investigational product in relation to placebo product on TEWL | Assessment of the effects of investigational product on transepidermal water loss after 12 weeks of dietary supplementation. TEWL measurements will be performed using open chambre principle. | 12 weeks |
| Influence of investigational product in relation to placebo product on dermis thickness | 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. | 12 weeks |
| Influence of investigational product in relation to placebo product on wrinkles will be assessed using wrinkle area fraction measurements | Assessment of the effects of investigational product on facial wrinkles after 12 weeks of dietary supplementation will be done using wrinkle area fraction measurements. | 12 weeks |
| ID | Term |
|---|---|
| D003094 | Collagen |
| ID | Term |
|---|---|
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D016326 | Extracellular Matrix Proteins |
| D012596 | Scleroproteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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