- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03811977
The Effect of 12-Week Dietary Intake of Lutein on Minimal Erythema Dose and Other Skin Parameters (VIST Lutein)
August 30, 2019 updated by: VIST - Faculty of Applied Sciences
The Effect of 12-Week Dietary Intake of Lutein on Minimal Erythema Dose and Other Skin Parameters: Randomised Double-Blind Placebo Controlled Study
The double-center, randomized, placebo-controlled, one-period effectiveness study will include 30 subjects (women, aged between 25 to 55 years, Fitzpatrick phototype II and III).
Subjects will be divided in two groups, 15 in each.
One group (test group) will receive investigational product - lutein syrup (4 mg/mL; daily dose 20 mg) and the other (placebo group) placebo syrup.
Participants will test continuous administration of placebo or investigational product for 12 weeks in order to demonstrate and assess multiple-dose effects.
The primary objective is to assess the photoprotective potential of the investigational product in relation to placebo product.
The secondary objectives are to assess effects of investigational product on dermis density and skin viscoelasticity after 12 weeks of dietary supplementation.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ljubljana, Slovenia, 1000
- Higher School of Applied Sciences, Institute of Cosmetics
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Caucasian female volunteers aged between 25 and 55 years at the time of the signature of Informed consent form (ICF),
- Signed Informed consent form (ICF),
- Fitzpatrick skin phototypes II and III,
- No skin pigmentation disorders,
- In good health condition,
- Willingness to avoid a consumption of any food supplements containing carotenes or other antioxidants during the study,
- Willingness to avoid the sun, tanning beds and tanning products on the gluteal area during the study,
- Willingness to follow all study procedures and keeping a diary for during the study (to follow their compliance and palatability),
- No changes in dietary habits or dietary supplements in last month prior to inclusion.
- No changes in cosmetic facial and body care routine in last month prior to inclusion on measurement areas.
Exclusion Criteria:
- Pregnancy or breastfeeding,
- Known or suspected allergy to any ingredient of the tested products or UV radiation,
- Changes in dietary habits and dietary supplementation in last month prior to inclusion,
- Veganism,
- Changes in cosmetic facial and body care routine in last month prior to inclusion.
- Diagnosed and uncontrolled/untreated/unregulated disease,
- Any clinically significant history of serious metabolic disease, digestive tract disease, liver disease, kidney disease, haematological disease.
- Acute skin diseases,
- Regular consumption of food supplements containing carotenoids or other antioxidants in last month before inclusion into the study.
- Invasive rejuvenation treatments (e.g. needle rollers, needle mesotherapy, deep/medium-deep chemical peels etc.) in last 6 months prior to study entry,
- Non-invasive rejuvenation treatments (e.g. radiofrequency, electrotherapy, ultrasound therapy) in last 2 months prior to study entry,
- Gluteal hyperpigmentation,
- Mental incapacity that precludes adequate understanding or cooperation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test group
Test group will receive investigational product - lutein syrup (2 mg/mL; daily dose 20 mg).
Participants in this group will test continuous administration of investigational product for 12 weeks.
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12- week dietary supplementation with lutein syrup (20 mg lutein/day)
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Placebo Comparator: Placebo group
Placebo group will receive placebo product - placebo syrup (lutein 0 mg/mL; daily dose 0 mg).
Continuous administration of placebo product for 12 weeks.
|
12- week dietary supplementation with placebo syrup (0 mg lutein/day)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Photoprotective potential of the investigational product in relation to placebo product assessed through measurements of minimal erythema dose
Time Frame: 12 weeks
|
The primary objective is to assess the photoprotective potential of the investigational product in relation to placebo product.
It will be assessed through measurements of minimal erythema dose with MED Tester using UVB irradiation.
Significant change of minimal erythema dose from baseline in test group, in comparison to placebo group, after 12 weeks of dietary supplementation with study product is expected.
|
12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Influence of investigational product in relation to placebo product on dermis density assessed through dermis intensity measurement
Time Frame: 12 weeks
|
Significant change of dermis density from baseline in test group, in comparison to placebo group after 12 weeks of dietary supplementation with study product is expected.
Dermis density will be assessed through ultrasonographic dermis intensity measurement.
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12 weeks
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Influence of the investigational product in relation to placebo product on skin elasticity assessed through measurements of viscoelasticity
Time Frame: 12 weeks
|
For assessments of skin elasticity viscoelasticity measurements will be performed.
Significant change of skin easticity from baseline in test group, in comparison to placebo group after 12 weeks of dietary supplementation with study product is expected.
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12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Katja Žmitek, Head of research group
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 4, 2019
Primary Completion (Actual)
July 2, 2019
Study Completion (Actual)
August 30, 2019
Study Registration Dates
First Submitted
January 17, 2019
First Submitted That Met QC Criteria
January 18, 2019
First Posted (Actual)
January 22, 2019
Study Record Updates
Last Update Posted (Actual)
September 3, 2019
Last Update Submitted That Met QC Criteria
August 30, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VIST F4F Lutein-MED 01-2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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