CompletedNot Applicable

The Effect of 12-Week Dietary Intake of Lutein on Minimal Erythema Dose and Other Skin Parameters

Slovenia30 participantsStarted 2019-03-04

Plain-language summary

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.

Who can participate

Age range

25 Years – 55 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 befo…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Photoprotective potential of the investigational product in relation to placebo product assessed through measurements of minimal erythema dose

Timeframe: 12 weeks

Trial details

NCT IDNCT03811977

SponsorVIST - Faculty of Applied Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-07-02

View on ClinicalTrials.gov More Minimal Erythema Dose trials