Healthy Clinical Trial
Official title:
A 12-Week, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Benefits of FloraGLO™ Lutein on Skin Health
NCT number | NCT03769779 |
Other study ID # | 4251KM0918 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 6, 2019 |
Est. completion date | March 30, 2020 |
Verified date | December 2018 |
Source | Kemin Foods LC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | March 30, 2020 |
Est. primary completion date | December 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 30 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Females in good health, and between the ages of 30 and 65 years old 2. Fitzpatrick Skin Type I-V 3. Mild to moderate loss of skin elasticity, wrinkles (global) and rough skin texture 4. Able to read, understand and sign an informed consent form 5. Willing and able to follow all study directions, attend study visits as scheduled and willing to accept the restrictions of the study 6. Willing and able to maintain regular diet, exercise, hydration, and sleep patterns throughout the study Exclusion Criteria: 1. Participating in any other clinical study 2. Acute or chronic disease or medical condition 3. Unreliable or unlikely to be available for the duration of the study 4. Routine use of tanning bed(s) 5. History of abnormal response to sunshine 6. Current usage of medications with contraindication of enhancing sun exposure, or medications for skin conditions. 7. History of allergic reactions, skin sensitization and/or known allergies to cosmetic ingredients, toiletries, sunscreens, etc. 8. Immunocompromised subjects 9. Subject has a history of unconventional sleep patterns 10. Started Hormone Replacement Therapy within the last three months 11. Using oral contraception for less than three months 12. Known to be pregnant, lactating or planning to become pregnant within six months 13. Unable to communicate or cooperate with the Principal Investigator due to language problems, poor mental development, or impaired cerebral function |
Country | Name | City | State |
---|---|---|---|
United States | International Research Services, Inc. | Port Chester | New York |
Lead Sponsor | Collaborator |
---|---|
Kemin Foods LC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective Skin Hydration | Corneometer Value | ANOVA including weeks 6 and 12 | |
Primary | Subjective Skin Hydration | Subjective Questionnaire Visual Analog Scale | ANOVA including weeks 6 and 12 | |
Secondary | Objective Skin Texture | Expert clinical grading | ANOVA including weeks 6 and 12 | |
Secondary | Subjective Skin Texture | Subjective Questionnaire Visual Analog Scale | ANOVA including weeks 6 and 12 | |
Secondary | Objective Facial Lines and Wrinkles | Expert clinical grading | ANOVA including weeks 6 and 12 | |
Secondary | Subjective Facial Lines and Wrinkles | Subjective Questionnaire Visual Analog Scale | ANOVA including weeks 6 and 12 | |
Secondary | Objective Sagging skin, dry skin, skin tone, and overall appearance | Expert clinical grading | ANOVA including weeks 6 and 12 | |
Secondary | Subjective Sagging skin, dry skin, skin tone, and overall appearance | Subjective Questionnaire Visual Analog Scale | ANOVA including weeks 6 and 12 | |
Secondary | Objective Skin elasticity | Expert clinical grading | ANOVA including weeks 6 and 12 | |
Secondary | Subjective Skin elasticity | Subjective Questionnaire Visual Analog Scale | ANOVA including weeks 6 and 12 | |
Secondary | Skin Collagen Ultrasound | Ultrasound | ANOVA including weeks 6 and 12 | |
Secondary | Skin Collagen SIAsScope | SIAsScope assessments | ANOVA including weeks 6 and 12 | |
Secondary | Skin Lipids | HPLC of tape strips | ANOVA including weeks 6 and 12 | |
Secondary | Skin Carotenoids | Total carotenoid concentration | ANOVA including weeks 6 and 12 |
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