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Therefore, the present study is designed to contribute to the body of literature by investigating the effect of 12-weeks of lutein supplementation on multiple parameters of skin health and appearance in healthy women.
This is a randomized, double-blind, placebo-controlled, parallel twelve-week study of the performance of an oral test product to evaluate the effects of twelve weeks of lutein supplementation on skin health and appearance in healthy women. A seven-day washout period will precede the evaluation period. The subjects in each cohort will use consume one softgel of their assigned test product (treatment or placebo) daily in the morning with breakfast for 12 weeks. Changes in skin condition and appearance as well as blood chemistry will be assessed using results from expert visual grading, instrumental assessments, skin and blood assays and subjective questionnaire responses. Subjects will be recruited during the winter season to account for seasonal variations of skin parameters.
Evaluation points will occur pre-application (Baseline; Week 0) and after 42 and 84 days of use (D42, D84; Week 6, Week 12). Data will be collected on the following outcomes:
1. Skin Hydration 2. Skin texture/smoothness 2. Reduction of facial fine lines and wrinkles 3. Skin elasticity and firmness 4. Sagging skin, dry skin, skin tone, appearance from expert clinical grading and subjective questionnaire responses.
6. Skin hydration 7. Skin collagen 8. Skin lipid content. 9. Skin Carotenoids
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Lutein (FloraGLOâ„¢) in safflower oil |
|
| Placebo | Placebo Comparator | safflower oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FloraGLO Lutein | Dietary Supplement | Lutein (FloraGLOâ„¢) in safflower oil |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Skin Hydration | Corneometer Value | ANOVA including weeks 6 and 12 |
| Subjective Skin Hydration | Subjective Questionnaire Visual Analog Scale | ANOVA including weeks 6 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Skin Texture | Expert clinical grading | ANOVA including weeks 6 and 12 |
| Subjective Skin Texture | Subjective Questionnaire Visual Analog Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Research Services, Inc. | Port Chester | New York | 10573 | United States |
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| ID | Term |
|---|---|
| D012450 | Safflower Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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Randomized, Double-Blind, Placebo-Controlled, Parallel Study
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Envelopes that contain information regarding the coding of treatment and placebo will be provided to Sponsor, Site, and PI and kept in a secure location. Envelopes will be readily available for the investigator or site to open in the event that it becomes necessary to know which product a participant is taking for the sake of the participant health care. The sponsor must be notified of any unblinding by the site within 24 hours.
| Safflower Oil |
| Dietary Supplement |
Safflower Oil |
|
| ANOVA including weeks 6 and 12 |
| Objective Facial Lines and Wrinkles | Expert clinical grading | ANOVA including weeks 6 and 12 |
| Subjective Facial Lines and Wrinkles | Subjective Questionnaire Visual Analog Scale | ANOVA including weeks 6 and 12 |
| Objective Sagging skin, dry skin, skin tone, and overall appearance | Expert clinical grading | ANOVA including weeks 6 and 12 |
| Subjective Sagging skin, dry skin, skin tone, and overall appearance | Subjective Questionnaire Visual Analog Scale | ANOVA including weeks 6 and 12 |
| Objective Skin elasticity | Expert clinical grading | ANOVA including weeks 6 and 12 |
| Subjective Skin elasticity | Subjective Questionnaire Visual Analog Scale | ANOVA including weeks 6 and 12 |
| Skin Collagen Ultrasound | Ultrasound | ANOVA including weeks 6 and 12 |
| Skin Collagen SIAsScope | SIAsScope assessments | ANOVA including weeks 6 and 12 |
| Skin Lipids | HPLC of tape strips | ANOVA including weeks 6 and 12 |
| Skin Carotenoids | Total carotenoid concentration | ANOVA including weeks 6 and 12 |
| D005224 |
| Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |