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Evaluation of the Benefits of FloraGLO™ Lutein on Skin Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03769779
Recruitment Status : Recruiting
First Posted : December 10, 2018
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Kemin Foods LC

Tracking Information
First Submitted Date  ICMJE December 4, 2018
First Posted Date  ICMJE December 10, 2018
Last Update Posted Date March 29, 2019
Actual Study Start Date  ICMJE March 6, 2019
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Evaluation of the Benefits of FloraGLO™ Lutein on Skin Health
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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  ICMJE
  • Aging
  • Wrinkle
  • Skin Elasticity
  • Healthy
  • Hydration
Intervention  ICMJE
  • Dietary Supplement: FloraGLO Lutein
    Lutein (FloraGLO™) in safflower oil
  • Dietary Supplement: Safflower Oil
    Safflower Oil
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 5, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2019
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Stephen R Schwartz 914.937.6500 sschwartz@irsi.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03769779
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Kemin Foods LC
Study Sponsor  ICMJE Kemin Foods LC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kemin Foods LC
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP