Evaluation of the Benefits of FloraGLO™ Lutein on Skin Health

• Sponsor: Kemin Foods LC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03769779
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.8
• Patients Per Site Per Month: 4.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aging; Wrinkle; Skin Elasticity; Healthy; Hydration	Dietary Supplement: FloraGLO Lutein; Dietary Supplement: Safflower Oil	N/A

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

2. Skin elasticity and firmness 4. Sagging skin, dry skin, skin tone, appearance from expert clinical grading and subjective questionnaire responses.

3. Skin hydration 7. Skin collagen 8. Skin lipid content. 9. Skin Carotenoids

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized, Double-Blind, Placebo-Controlled, Parallel StudyRandomized, Double-Blind, Placebo-Controlled, Parallel Study
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Prevention
• Official Title: A 12-Week, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Benefits of FloraGLO™ Lutein on Skin Health
• Actual Study Start Date: Mar 6, 2019
• Actual Primary Completion Date: Dec 30, 2019
• Actual Study Completion Date: Mar 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Lutein (FloraGLO™) in safflower oil	Dietary Supplement: FloraGLO Lutein; Lutein (FloraGLO™) in safflower oil
Placebo Comparator: Placebo safflower oil	Dietary Supplement: Safflower Oil; Safflower Oil

Outcome Measures

Primary Outcome Measures

1. Objective Skin Hydration [ANOVA including weeks 6 and 12]

   Corneometer Value

2. Subjective Skin Hydration [ANOVA including weeks 6 and 12]

   Subjective Questionnaire Visual Analog Scale

Secondary Outcome Measures

1. Objective Skin Texture [ANOVA including weeks 6 and 12]

   Expert clinical grading

2. Subjective Skin Texture [ANOVA including weeks 6 and 12]

   Subjective Questionnaire Visual Analog Scale

3. Objective Facial Lines and Wrinkles [ANOVA including weeks 6 and 12]

   Expert clinical grading

4. Subjective Facial Lines and Wrinkles [ANOVA including weeks 6 and 12]

   Subjective Questionnaire Visual Analog Scale

5. Objective Sagging skin, dry skin, skin tone, and overall appearance [ANOVA including weeks 6 and 12]

   Expert clinical grading

6. Subjective Sagging skin, dry skin, skin tone, and overall appearance [ANOVA including weeks 6 and 12]

   Subjective Questionnaire Visual Analog Scale

7. Objective Skin elasticity [ANOVA including weeks 6 and 12]

   Expert clinical grading

8. Subjective Skin elasticity [ANOVA including weeks 6 and 12]

   Subjective Questionnaire Visual Analog Scale

9. Skin Collagen Ultrasound [ANOVA including weeks 6 and 12]

   Ultrasound

10. Skin Collagen SIAsScope [ANOVA including weeks 6 and 12]

    SIAsScope assessments

11. Skin Lipids [ANOVA including weeks 6 and 12]

    HPLC of tape strips

12. Skin Carotenoids [ANOVA including weeks 6 and 12]

    Total carotenoid concentration

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	International Research Services, Inc.	Port Chester	New York	United States	10573

Sponsors and Collaborators

• Kemin Foods LC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kemin Foods LC
• ClinicalTrials.gov Identifier: NCT03769779
• Other Study ID Numbers: 4251KM0918
• First Posted: Dec 10, 2018
• Last Update Posted: Feb 3, 2021
• Last Verified: Dec 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 3, 2021