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

NCT03811977 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-09-03

No results posted yet for this 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

  • Minimal Erythema Dose
  • Skin Viscoelasticity
  • Dermis Density

Interventions

DIETARY_SUPPLEMENT

Lutein syrup

12- week dietary supplementation with lutein syrup (20 mg lutein/day)

DIETARY_SUPPLEMENT

Placebo syrup

12- week dietary supplementation with placebo syrup (0 mg lutein/day)

Sponsors & Collaborators

  • European Regional Development Fund

    collaborator OTHER

  • Ministry of Education, Science and Sport, Republic of Slovenia

    collaborator UNKNOWN

  • Dermatologija Bartenjev Rogl

    collaborator UNKNOWN

  • Slovenian Research Agency

    collaborator OTHER

  • Valens Int. d.o.o., Slovenija

    collaborator INDUSTRY

  • VIST - Faculty of Applied Sciences

    lead OTHER

Principal Investigators

  • Katja Žmitek · Head of Research Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-04
Primary Completion
2019-07-02
Completion
2019-08-30

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03811977 on ClinicalTrials.gov