Evaluation of the Benefits of FloraGLO™ Lutein on Skin Health

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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A 12-Week, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Benefits of FloraGLO™ Lutein on Skin Health

Conditions
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Aging, Wrinkle, Skin Elasticity, Healthy, Hydration

Intervention / Treatment
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* Dietary Supplement: FloraGLO Lutein
* Dietary Supplement: Safflower Oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females in good health, and between the ages of 30 and 65 years old Fitzpatrick Skin Type I-V Mild to moderate loss of skin elasticity, wrinkles (global) and rough skin texture Able to read, understand and sign an informed consent form Willing and able to follow all study directions, attend study visits as scheduled and willing to accept the restrictions of the study Willing and able to maintain regular diet, exercise, hydration, and sleep patterns throughout the study Exclusion Criteria: Participating in any other clinical study Acute or chronic disease or medical condition Unreliable or unlikely to be available for the duration of the study Routine use of tanning bed(s) History of abnormal response to sunshine Current usage of medications with contraindication of enhancing sun exposure, or medications for skin conditions. History of allergic reactions, skin sensitization and/or known allergies to cosmetic ingredients, toiletries, sunscreens, etc. Immunocompromised subjects Subject has a history of unconventional sleep patterns Started Hormone Replacement Therapy within the last three months Using oral contraception for less than three months Known to be pregnant, lactating or planning to become pregnant within six months Unable to communicate or cooperate with the Principal Investigator due to language problems, poor mental development, or impaired cerebral function

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Double-Blind, Placebo-Controlled, Parallel Study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Lutein (FloraGLO™) in safflower oil | Dietary Supplement: FloraGLO Lutein<br>* Lutein (FloraGLO™) in safflower oil<br>|
| Placebo Comparator: Placebo<br>safflower oil | Dietary Supplement: Safflower Oil<br>* Safflower Oil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Skin Texture | Expert clinical grading | ANOVA including weeks 6 and 12 | 
| Subjective Skin Texture | Subjective Questionnaire Visual Analog Scale | 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 |