Evaluation of the Benefits of FloraGLO™ Lutein on Skin Health

A 12-Week, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Benefits of FloraGLO™ Lutein on Skin Health

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Aging; Hydration; Wrinkle; Skin Elasticity
• Intervention / Treatment: Dietary supplement: FloraGLO Lutein; Dietary supplement: Safflower Oil

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
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Port Chester, New York, United States, 10573
      • International Research Services, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Skin Hydration	Corneometer Value	ANOVA including weeks 6 and 12
Subjective Skin Hydration	Subjective Questionnaire Visual Analog Scale	ANOVA including weeks 6 and 12

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kemin Foods LC

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2019
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): March 30, 2020

Study Registration Dates

• First Submitted: December 4, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (Actual): December 10, 2018

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 4251KM0918

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No