The Effect of 12-Week Dietary Intake of Lutein on Minimal Erythema Dose and Other Skin Parameters

Study Overview
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Brief Summary
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The double-center, randomized, placebo-controlled, one-period effectiveness study will include 30 subjects (women, aged between 25 to 55 years, Fitzpatrick phototype II and III). Subjects will be divided in two groups, 15 in each. One group (test group) will receive investigational product - lutein syrup (4 mg/mL; daily dose 20 mg) and the other (placebo group) placebo syrup. Participants will test continuous administration of placebo or investigational product for 12 weeks in order to demonstrate and assess multiple-dose effects. The primary objective is to assess the photoprotective potential of the investigational product in relation to placebo product. The secondary objectives are to assess effects of investigational product on dermis density and skin viscoelasticity after 12 weeks of dietary supplementation.

Official Title
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The Effect of 12-Week Dietary Intake of Lutein on Minimal Erythema Dose and Other Skin Parameters: Randomised Double-Blind Placebo Controlled Study

Conditions
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Minimal Erythema Dose, Skin Viscoelasticity, Dermis Density

Intervention / Treatment
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* Dietary Supplement: Lutein syrup
* Dietary Supplement: Placebo syrup


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Caucasian female volunteers aged between 25 and 55 years at the time of the signature of Informed consent form (ICF), Signed Informed consent form (ICF), Fitzpatrick skin phototypes II and III, No skin pigmentation disorders, In good health condition, Willingness to avoid a consumption of any food supplements containing carotenes or other antioxidants during the study, Willingness to avoid the sun, tanning beds and tanning products on the gluteal area during the study, Willingness to follow all study procedures and keeping a diary for during the study (to follow their compliance and palatability), No changes in dietary habits or dietary supplements in last month prior to inclusion. No changes in cosmetic facial and body care routine in last month prior to inclusion on measurement areas. Exclusion Criteria: Pregnancy or breastfeeding, Known or suspected allergy to any ingredient of the tested products or UV radiation, Changes in dietary habits and dietary supplementation in last month prior to inclusion, Veganism, Changes in cosmetic facial and body care routine in last month prior to inclusion. Diagnosed and uncontrolled/untreated/unregulated disease, Any clinically significant history of serious metabolic disease, digestive tract disease, liver disease, kidney disease, haematological disease. Acute skin diseases, Regular consumption of food supplements containing carotenoids or other antioxidants in last month before inclusion into the study. Invasive rejuvenation treatments (e.g. needle rollers, needle mesotherapy, deep/medium-deep chemical peels etc.) in last 6 months prior to study entry, Non-invasive rejuvenation treatments (e.g. radiofrequency, electrotherapy, ultrasound therapy) in last 2 months prior to study entry, Gluteal hyperpigmentation, Mental incapacity that precludes adequate understanding or cooperation

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>Test group will receive investigational product - lutein syrup (2 mg/mL; daily dose 20 mg). Participants in this group will test continuous administration of investigational product for 12 weeks. | Dietary Supplement: Lutein syrup<br>* 12- week dietary supplementation with lutein syrup (20 mg lutein/day)<br>|
| Placebo Comparator: Placebo group<br>Placebo group will receive placebo product - placebo syrup (lutein 0 mg/mL; daily dose 0 mg). Continuous administration of placebo product for 12 weeks. | Dietary Supplement: Placebo syrup<br>* 12- week dietary supplementation with placebo syrup (0 mg lutein/day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photoprotective potential of the investigational product in relation to placebo product assessed through measurements of minimal erythema dose | The primary objective is to assess the photoprotective potential of the investigational product in relation to placebo product. It will be assessed through measurements of minimal erythema dose with MED Tester using UVB irradiation. Significant change of minimal erythema dose from baseline in test group, in comparison to placebo group, after 12 weeks of dietary supplementation with study product is expected. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Influence of the investigational product in relation to placebo product on skin elasticity assessed through measurements of viscoelasticity | For assessments of skin elasticity viscoelasticity measurements will be performed. Significant change of skin easticity from baseline in test group, in comparison to placebo group after 12 weeks of dietary supplementation with study product is expected. | 12 weeks |