Evaluation of the Benefits of FloraGLO™ Lutein on Skin Health

NCT ID: NCT03769779

Last Updated: 2021-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-06
• Study Completion Date: 2020-03-30

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

Conditions

Aging; Wrinkle; Skin Elasticity; Healthy; Hydration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment

Lutein (FloraGLO™) in safflower oil

Group Type: EXPERIMENTAL

FloraGLO Lutein

Intervention Type: DIETARY_SUPPLEMENT

Lutein (FloraGLO™) in safflower oil

Placebo

safflower oil

Group Type: PLACEBO_COMPARATOR

Safflower Oil

Intervention Type: DIETARY_SUPPLEMENT

Safflower Oil

Interventions

FloraGLO Lutein

Lutein (FloraGLO™) in safflower oil

Intervention Type: DIETARY_SUPPLEMENT

Safflower Oil

Safflower Oil

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kemin Foods LC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

International Research Services, Inc.

Port Chester, New York, United States

Countries

United States

Other Identifiers

4251KM0918

Identifier Type: -

Identifier Source: org_study_id