Clinical trial NCT03769779: Evaluation of the Benefits of FloraGLO™ Lutein on Skin Health
Official title: A 12-Week, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Benefits of FloraGLO™ Lutein on Skin Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Wrinkle
Skin Elasticity
Healthy
Hydration
Lead sponsor: Kemin Foods LC
Sponsor class: INDUSTRY
First posted: 2018-12-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double-Blind, Placebo-Controlled, Parallel Study
Primary purpose: PREVENTION

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Objective Skin Hydration
timeFrame: ANOVA including weeks 6 and 12
measure: Subjective Skin Hydration
timeFrame: ANOVA including weeks 6 and 12
Secondary outcomes:
measure: Objective Skin Texture
timeFrame: ANOVA including weeks 6 and 12
measure: Subjective Skin Texture
timeFrame: ANOVA including weeks 6 and 12
measure: Objective Facial Lines and Wrinkles
timeFrame: ANOVA including weeks 6 and 12
measure: Subjective Facial Lines and Wrinkles
timeFrame: ANOVA including weeks 6 and 12
measure: Objective Sagging skin, dry skin, skin tone, and overall appearance
timeFrame: ANOVA including weeks 6 and 12
measure: Subjective Sagging skin, dry skin, skin tone, and overall appearance
timeFrame: ANOVA including weeks 6 and 12
measure: Objective Skin elasticity
timeFrame: ANOVA including weeks 6 and 12
measure: Subjective Skin elasticity
timeFrame: ANOVA including weeks 6 and 12
measure: Skin Collagen Ultrasound
timeFrame: ANOVA including weeks 6 and 12
measure: Skin Collagen SIAsScope
timeFrame: ANOVA including weeks 6 and 12
measure: Skin Lipids
timeFrame: ANOVA including weeks 6 and 12
measure: Skin Carotenoids
timeFrame: ANOVA including weeks 6 and 12
Other outcomes:
Locations:
city: Port Chester
country: United States
facility: International Research Services, Inc.
state: New York
Study officials:
References: