Evaluation of the Benefits of FloraGLO™ Lutein on Skin Health

Not Applicable

Completed

• Conditions: Wrinkle; Skin Elasticity; Hydration; Healthy; Aging
• Interventions: Dietary Supplement: FloraGLO Lutein; Dietary Supplement: Safflower Oil

• Registration Number: NCT03769779
• Lead Sponsor: Kemin Foods LC

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

Study Timeline

• Status Verified: 2018-12
• Study First Submitted: 2018-12-04
• Study First Submitted QC: 2018-12-05
• Study First Posted: 2018-12-10
• Study Start: 2019-03-06
• Primary Completion: 2019-12-30
• Study Completion: 2020-03-30
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	FloraGLO Lutein	Lutein (FloraGLO™) in safflower oil
Placebo	Safflower Oil	safflower oil

Primary Outcome Measures

Name	Time	Method
Subjective Skin Hydration	ANOVA including weeks 6 and 12	Subjective Questionnaire Visual Analog Scale
Objective Skin Hydration	ANOVA including weeks 6 and 12	Corneometer Value

Secondary Outcome Measures

Name	Time	Method
Objective Skin Texture	ANOVA including weeks 6 and 12	Expert clinical grading
Objective Facial Lines and Wrinkles	ANOVA including weeks 6 and 12	Expert clinical grading
Skin Collagen SIAsScope	ANOVA including weeks 6 and 12	SIAsScope assessments
Skin Carotenoids	ANOVA including weeks 6 and 12	Total carotenoid concentration
Subjective Facial Lines and Wrinkles	ANOVA including weeks 6 and 12	Subjective Questionnaire Visual Analog Scale
Subjective Skin Texture	ANOVA including weeks 6 and 12	Subjective Questionnaire Visual Analog Scale
Objective Skin elasticity	ANOVA including weeks 6 and 12	Expert clinical grading
Skin Lipids	ANOVA including weeks 6 and 12	HPLC of tape strips
Skin Collagen Ultrasound	ANOVA including weeks 6 and 12	Ultrasound
Objective Sagging skin, dry skin, skin tone, and overall appearance	ANOVA including weeks 6 and 12	Expert clinical grading
Subjective Skin elasticity	ANOVA including weeks 6 and 12	Subjective Questionnaire Visual Analog Scale
Subjective Sagging skin, dry skin, skin tone, and overall appearance	ANOVA including weeks 6 and 12	Subjective Questionnaire Visual Analog Scale

Trial Locations

Locations (1)

International Research Services, Inc.; 🇺🇸 Port Chester, New York, United States