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

NCT ID: NCT03811977

Last Updated: 2019-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-04
• Study Completion Date: 2019-08-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Lutein syrup

Intervention Type: DIETARY_SUPPLEMENT

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo syrup

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Lutein syrup

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo syrup

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

European Regional Development Fund

OTHER

Sponsor Role: collaborator

Ministry of Education, Science and Sport, Republic of Slovenia

UNKNOWN

Sponsor Role: collaborator

Dermatologija Bartenjev Rogl

UNKNOWN

Sponsor Role: collaborator

Slovenian Research Agency

OTHER

Sponsor Role: collaborator

Valens Int. d.o.o., Slovenija

INDUSTRY

Sponsor Role: collaborator

VIST - Faculty of Applied Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katja Žmitek

Role: STUDY_DIRECTOR

Head of Research Group

Locations

Higher School of Applied Sciences, Institute of Cosmetics

Ljubljana, , Slovenia

Countries

Slovenia

Other Identifiers

VIST F4F Lutein-MED 01-2018

Identifier Type: -

Identifier Source: org_study_id