Status:
COMPLETED
Evaluation of the Benefits of FloraGLO™ Lutein on Skin Health
Lead Sponsor:
Kemin Foods LC
Conditions:
Aging
Wrinkle
Eligibility:
FEMALE
30-65 years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03769779
Start Date
March 6 2019
End Date
March 30 2020
Last Update
February 3 2021
Active Locations (1)
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1
International Research Services, Inc.
Port Chester, New York, United States, 10573