## Protocol Section
### Identification Module
**NCT ID:** NCT03769779

**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

#### Organization Study ID Info
**ID:** 4251KM0918
#### Organization
**Class:** INDUSTRY
**Full Name:** Kemin Foods LC
### Status Module
#### Completion Date
**Date:** 2020-03-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-02-03

**Type:** ACTUAL

**Last Update Submit Date:** 2021-02-02

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-12-30

**Type:** ACTUAL

#### Start Date
**Date:** 2019-03-06

**Type:** ACTUAL

**Status Verified Date:** 2018-12

#### Study First Post Date
**Date:** 2018-12-10
**Type:** ACTUAL
**Study First Submit Date:** 2018-12-04
**Study First Submit QC Date:** 2018-12-05
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Kemin Foods LC

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Aging

- Wrinkle

- Skin Elasticity

- Healthy

- Hydration

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Randomized, Double-Blind, Placebo-Controlled, Parallel Study

##### Masking Info

**Masking:** QUADRUPLE

**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.

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 60

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Lutein (FloraGLO™) in safflower oil

**Intervention Names:**

- Dietary Supplement: FloraGLO Lutein

**Label:** Treatment

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** safflower oil

**Intervention Names:**

- Dietary Supplement: Safflower Oil

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Treatment

**Description:** Lutein (FloraGLO™) in safflower oil

**Name:** FloraGLO Lutein

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Safflower Oil

**Name:** Safflower Oil

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** Corneometer Value

**Measure:** Objective Skin Hydration

**Time Frame:** ANOVA including weeks 6 and 12

**Description:** Subjective Questionnaire Visual Analog Scale

**Measure:** Subjective Skin Hydration

**Time Frame:** ANOVA including weeks 6 and 12

#### Secondary Outcomes

**Description:** Expert clinical grading

**Measure:** Objective Skin Texture

**Time Frame:** ANOVA including weeks 6 and 12

**Description:** Subjective Questionnaire Visual Analog Scale

**Measure:** Subjective Skin Texture

**Time Frame:** ANOVA including weeks 6 and 12

**Description:** Expert clinical grading

**Measure:** Objective Facial Lines and Wrinkles

**Time Frame:** ANOVA including weeks 6 and 12

**Description:** Subjective Questionnaire Visual Analog Scale

**Measure:** Subjective Facial Lines and Wrinkles

**Time Frame:** ANOVA including weeks 6 and 12

**Description:** Expert clinical grading

**Measure:** Objective Sagging skin, dry skin, skin tone, and overall appearance

**Time Frame:** ANOVA including weeks 6 and 12

**Description:** Subjective Questionnaire Visual Analog Scale

**Measure:** Subjective Sagging skin, dry skin, skin tone, and overall appearance

**Time Frame:** ANOVA including weeks 6 and 12

**Description:** Expert clinical grading

**Measure:** Objective Skin elasticity

**Time Frame:** ANOVA including weeks 6 and 12

**Description:** Subjective Questionnaire Visual Analog Scale

**Measure:** Subjective Skin elasticity

**Time Frame:** ANOVA including weeks 6 and 12

**Description:** Ultrasound

**Measure:** Skin Collagen Ultrasound

**Time Frame:** ANOVA including weeks 6 and 12

**Description:** SIAsScope assessments

**Measure:** Skin Collagen SIAsScope

**Time Frame:** ANOVA including weeks 6 and 12

**Description:** HPLC of tape strips

**Measure:** Skin Lipids

**Time Frame:** ANOVA including weeks 6 and 12

**Description:** Total carotenoid concentration

**Measure:** Skin Carotenoids

**Time Frame:** ANOVA including weeks 6 and 12

### Eligibility Module

**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

**Gender Based:** True

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 30 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Port Chester

**Country:** United States

**Facility:** International Research Services, Inc.

**State:** New York

**Zip:** 10573

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: Ot

- Name: Other Dietary Supplements

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T407

- Name: Lutein

- Relevance: HIGH

- As Found: Neurostimulation

### Misc Info Module

- Version Holder: 2024-05-24
