Evaluation of the Benefits of FloraGLO™ Lutein on Skin Health

• ClinicalTrials.gov Identifier: NCT03769779
• Recruitment Status: Recruiting
• First Posted: December 10, 2018
• Last Update Posted: March 29, 2019
• Sponsor: Kemin Foods LC
• Information provided by (Responsible Party): Kemin Foods LC

Tracking Information

• First Submitted Date: December 4, 2018
• First Posted Date: December 10, 2018
• Last Update Posted Date: March 29, 2019
• Actual Study Start Date: March 6, 2019
• Estimated Primary Completion Date: September 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 14, 2019)

• Objective Skin Hydration [ Time Frame: ANOVA including weeks 6 and 12 ]
  Corneometer Value
• Subjective Skin Hydration [ Time Frame: ANOVA including weeks 6 and 12 ]
  Subjective Questionnaire Visual Analog Scale

Original Primary Outcome Measures (submitted: December 5, 2018)

• Skin Hydration [ Time Frame: ANOVA including weeks 6 and 12 ]
  Corneometer Value
• Skin Hydration [ Time Frame: ANOVA including weeks 6 and 12 ]
  Subjective Questionnaire Visual Analog Scale

Current Secondary Outcome Measures (submitted: February 14, 2019)

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

Original Secondary Outcome Measures (submitted: December 5, 2018)

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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized, 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

Condition

• Aging
• Wrinkle
• Skin Elasticity
• Healthy
• Hydration

Intervention

• Dietary Supplement: FloraGLO Lutein
  Lutein (FloraGLO™) in safflower oil
• Dietary Supplement: Safflower Oil
  Safflower Oil

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 5, 2018): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 30, 2019
• Estimated Primary Completion Date: September 30, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes

• Ages: 30 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Stephen R Schwartz; 914.937.6500; sschwartz@irsi.org

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03769779
• Other Study ID Numbers: 4251KM0918
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Kemin Foods LC
• Study Sponsor: Kemin Foods LC
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Kemin Foods LC
• Verification Date: December 2018