AgingNCT03769779
Evaluation of the Benefits of FloraGLO™ Lutein on Skin Health
A study testing FloraGLO Lutein and Safflower Oil in people with Aging and Wrinkle, run by Kemin Foods LC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aging, Wrinkle, Skin Elasticity
- What is being tested?
- FloraGLO Lutein and Safflower Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2019to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
International Research Services, Inc.
Port Chester, New York, 10573
About this study
Official title: A 12-Week, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Benefits of FloraGLO™ Lutein on Skin Health
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.
Read the 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:
- 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.
- Skin hydration 7. Skin collagen 8. Skin lipid content. 9. Skin Carotenoids
- Conditions
- Aging, Wrinkle, Skin Elasticity, Healthy, Hydration
- Being tested
- FloraGLO Lutein, Safflower Oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FloraGLO LuteinDietary supplement
Lutein (FloraGLO™) in safflower oil
Safflower OilDietary supplement
Safflower Oil
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Lutein (FloraGLO™) in safflower oil Receives: Dietary Supplement: FloraGLO Lutein |
| Placebo | Placebo comparator | safflower oil Receives: Dietary Supplement: Safflower Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Skin Hydration
Corneometer Value
Measured: ANOVA including weeks 6 and 12
Subjective Skin Hydration
Subjective Questionnaire Visual Analog Scale
Measured: ANOVA including weeks 6 and 12
Secondary outcomes (12)
Objective Skin Texture
Expert clinical grading
Measured: ANOVA including weeks 6 and 12
Subjective Skin Texture
Subjective Questionnaire Visual Analog Scale
Measured: ANOVA including weeks 6 and 12
Objective Facial Lines and Wrinkles
Expert clinical grading
Measured: ANOVA including weeks 6 and 12
Subjective Facial Lines and Wrinkles
Subjective Questionnaire Visual Analog Scale
Measured: ANOVA including weeks 6 and 12
Objective Sagging skin, dry skin, skin tone, and overall appearance
Expert clinical grading
Measured: ANOVA including weeks 6 and 12
Subjective Sagging skin, dry skin, skin tone, and overall appearance
Subjective Questionnaire Visual Analog Scale
Measured: ANOVA including weeks 6 and 12
Objective Skin elasticity
Expert clinical grading
Measured: ANOVA including weeks 6 and 12
Subjective Skin elasticity
Subjective Questionnaire Visual Analog Scale
Measured: ANOVA including weeks 6 and 12
Skin Collagen Ultrasound
Ultrasound
Measured: ANOVA including weeks 6 and 12
Skin Collagen SIAsScope
SIAsScope assessments
Measured: ANOVA including weeks 6 and 12
Skin Lipids
HPLC of tape strips
Measured: ANOVA including weeks 6 and 12
Skin Carotenoids
Total carotenoid concentration
Measured: ANOVA including weeks 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start6 Mar 2019
- Primary completion30 Dec 2019
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Placebo-Controlled, Parallel Study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kemin Foods LC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03769779
- Sponsor's protocol ID
- 4251KM0918
- Status last verified
- Dec 2018
- First submitted
- 4 Dec 2018
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Benefits of FloraGLO™ Lutein on Skin Health
- ClinicalTrials.gov ID
- NCT03769779
- Acronym / sponsor ID
- 4251KM0918
- Conditions
- Aging, Wrinkle, Skin Elasticity, Healthy, Hydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kemin Foods LCIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 10 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Skin hydration 7. Skin collagen 8. Skin lipid content. 9. Skin Carotenoids
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Double-Blind, Placebo-Controlled, Parallel Study
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Dietary Supplement: FloraGLO LuteinLutein (FloraGLO™) in safflower oil |
| Placebo | Placebo comparator | Dietary Supplement: Safflower Oilsafflower oil |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FloraGLO LuteinLutein (FloraGLO™) in safflower oil | Dietary supplement | Treatment |
| Safflower OilSafflower Oil | Dietary supplement | Placebo |
Primary outcome
Objective Skin Hydration
Time frame: ANOVA including weeks 6 and 12
Corneometer Value
Subjective Skin Hydration
Time frame: ANOVA including weeks 6 and 12
Subjective Questionnaire Visual Analog Scale
12 secondary outcomes
Objective Skin Texture
Time frame: ANOVA including weeks 6 and 12
Subjective Skin Texture
Time frame: ANOVA including weeks 6 and 12
Objective Facial Lines and Wrinkles
Time frame: ANOVA including weeks 6 and 12
Subjective Facial Lines and Wrinkles
Time frame: ANOVA including weeks 6 and 12
Objective Sagging skin, dry skin, skin tone, and overall appearance
Time frame: ANOVA including weeks 6 and 12
Subjective Sagging skin, dry skin, skin tone, and overall appearance
Time frame: ANOVA including weeks 6 and 12
Objective Skin elasticity
Time frame: ANOVA including weeks 6 and 12
Subjective Skin elasticity
Time frame: ANOVA including weeks 6 and 12
Skin Collagen Ultrasound
Time frame: ANOVA including weeks 6 and 12
Skin Collagen SIAsScope
Time frame: ANOVA including weeks 6 and 12
Skin Lipids
Time frame: ANOVA including weeks 6 and 12
Skin Carotenoids
Time frame: ANOVA including weeks 6 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FloraGLO Lutein and Safflower Oil in people with Aging and Wrinkle, run by Kemin Foods LC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Skin Hydration (time frame: ANOVA including weeks 6 and 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.