Evaluation of the Benefits of FloraGLO™ Lutein on Skin Health

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03769779
• Other study ID #: 4251KM0918
• Status: Completed
• Phase: N/A
• Start date: March 6, 2019
• Est. completion date: March 30, 2020

Study information

• Verified date: December 2018
• Source: Kemin Foods LC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Healthy
• Hydration
• Skin Elasticity
• Wrinkle

Intervention

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

Locations

Country	Name	City	State
United States	International Research Services, Inc.	Port Chester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Kemin Foods LC

Country where clinical trial is conducted

United States, 

Outcome

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