NCT03811977

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

The Effect of 12-Week Dietary Intake of Lutein on Minimal Erythema Dose and Other Skin Parameters: Randomised Double-Blind Placebo Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: VIST - Faculty of Applied Sciences · Academic / Other
• Sex: Female
• Age: 25 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2019-03-04
• Primary completion: 2019-07-02
• Completion: 2019-08-30
• First posted: 2019-01-22
• Last updated: 2019-09-03

Locations

1 site across 1 country: Slovenia