CompletedNCT03811977VIST LuteinUpdated Sep 3, 2019

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

An interventional study of Lutein syrup and Placebo syrup in Minimal Erythema Dose, Skin Viscoelasticity and Dermis Density, sponsored by VIST - Faculty of Applied Sciences. Completed at 1 site in Slovenia. Open to female participants aged 25 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-03.

Sponsored by VIST - Faculty of Applied Sciences · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 25 Years to 55 Years
Sex: Female

Study 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.

Conditions studied

Minimal Erythema Dose
Skin Viscoelasticity
Dermis Density

In context

Lead sponsor

VIST - Faculty of Applied Sciences is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 25 Years to 55 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 30 participants (actual)

Study arms

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.
Dietary Supplement: Lutein syrup
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.
Dietary Supplement: Placebo syrup

Interventions

Dietary supplementLutein syrup
12- week dietary supplementation with lutein syrup (20 mg lutein/day)
Dietary supplementPlacebo syrup
12- week dietary supplementation with placebo syrup (0 mg lutein/day)

What researchers measure

Primary outcomes

Photoprotective potential of the investigational product in relation to placebo product assessed through measurements of minimal erythema dose
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.
Time frame: 12 weeks

Secondary outcomes

Influence of investigational product in relation to placebo product on dermis density assessed through dermis intensity measurement
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.
Time frame: 12 weeks
Influence of the investigational product in relation to placebo product on skin elasticity assessed through measurements of viscoelasticity
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.
Time frame: 12 weeks

Study locations

1 site

Higher School of Applied Sciences, Institute of Cosmetics
Ljubljana, 1000, Slovenia

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2019 to primary completion in Jul 2019, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered: Jan 17, 2019
First posted: Jan 22, 2019
StartActual: Mar 4, 2019
Primary completionActual: Jul 2, 2019
CompletionActual: Aug 30, 2019
Last update: Sep 3, 2019

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Sep 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03811977
Lead sponsor: VIST - Faculty of Applied Sciences
Collaborators: European Regional Development Fund, Ministry of Higher Education, Science and Technology, Solvenia, Dermatologija Bartenjev Rogl, Slovenian Research Agency, Valens Int. d.o.o., Slovenija
Responsible party: Sponsor
First posted: Jan 22, 2019
Start date: Mar 4, 2019
Primary completion: Jul 2, 2019
Completion: Aug 30, 2019
Last update: Sep 3, 2019

Study contacts

Katja Žmitek

study director · Head of Research Group

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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