NCT03769779

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 10, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

March 6, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

February 3, 2021

Status Verified

December 1, 2018

Enrollment Period

10 months

First QC Date

December 4, 2018

Last Update Submit

February 2, 2021

Conditions

AgingWrinkleSkin ElasticityHealthyHydration

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (12)

  • Objective Skin Texture

    ANOVA including weeks 6 and 12

  • Subjective Skin Texture

    ANOVA including weeks 6 and 12

  • Objective Facial Lines and Wrinkles

    ANOVA including weeks 6 and 12

  • Subjective Facial Lines and Wrinkles

    ANOVA including weeks 6 and 12

  • Objective Sagging skin, dry skin, skin tone, and overall appearance

    ANOVA including weeks 6 and 12

  • +7 more secondary outcomes

Study Arms (2)

Treatment

EXPERIMENTAL

Lutein (FloraGLO™) in safflower oil

Dietary Supplement: FloraGLO Lutein

Placebo

PLACEBO COMPARATOR

safflower oil

Dietary Supplement: Safflower Oil

Interventions

FloraGLO LuteinDIETARY_SUPPLEMENT

Lutein (FloraGLO™) in safflower oil

Treatment
Safflower OilDIETARY_SUPPLEMENT

Safflower Oil

Placebo

Eligibility Criteria

Age30 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females in good health, and between the ages of 30 and 65 years old
  • Fitzpatrick Skin Type I-V
  • Mild to moderate loss of skin elasticity, wrinkles (global) and rough skin texture
  • Able to read, understand and sign an informed consent form
  • Willing and able to follow all study directions, attend study visits as scheduled and willing to accept the restrictions of the study
  • Willing and able to maintain regular diet, exercise, hydration, and sleep patterns throughout the study

You may not qualify if:

  • Participating in any other clinical study
  • Acute or chronic disease or medical condition
  • Unreliable or unlikely to be available for the duration of the study
  • Routine use of tanning bed(s)
  • History of abnormal response to sunshine
  • Current usage of medications with contraindication of enhancing sun exposure, or medications for skin conditions.
  • History of allergic reactions, skin sensitization and/or known allergies to cosmetic ingredients, toiletries, sunscreens, etc.
  • Immunocompromised subjects
  • Subject has a history of unconventional sleep patterns
  • Started Hormone Replacement Therapy within the last three months
  • Using oral contraception for less than three months
  • Known to be pregnant, lactating or planning to become pregnant within six months
  • Unable to communicate or cooperate with the Principal Investigator due to language problems, poor mental development, or impaired cerebral function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Research Services, Inc.

Port Chester, New York, 10573, United States

Location

MeSH Terms

Interventions

Safflower Oil

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized, Double-Blind, Placebo-Controlled, Parallel Study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2018

First Posted

December 10, 2018

Study Start

March 6, 2019

Primary Completion

December 30, 2019

Study Completion

March 30, 2020

Last Updated

February 3, 2021

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)