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

NCT03811977 | Completed

• 1 other identifier: VIST F4F Lutein-MED 01-2018
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (2)

• Influence of investigational product in relation to placebo product on dermis density assessed through dermis intensity measurement

  12 weeks

• Influence of the investigational product in relation to placebo product on skin elasticity assessed through measurements of viscoelasticity

  12 weeks

Study Arms (2)

Test group

EXPERIMENTAL

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 group

PLACEBO COMPARATOR

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

Lutein syrup DIETARY_SUPPLEMENT

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

Test group

Placebo syrup DIETARY_SUPPLEMENT

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

Placebo group

Eligibility Criteria

• Age: 25 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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),

You may not qualify if:

• Pregnancy or breastfeeding,
• Known or suspected allergy to any ingredient of the tested products or UV radiation,
• Veganism,
• 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,
• 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

Sponsors & Collaborators

• VIST - Faculty of Applied Sciences: lead
• European Regional Development Fund: collaborator
• Ministry of Education, Science and Sport, Republic of Slovenia: collaborator
• Dermatologija Bartenjev Rogl: collaborator
• Slovenian Research Agency: collaborator
• Valens Int. d.o.o., Slovenija: collaborator

Study Sites (1)

Higher School of Applied Sciences, Institute of Cosmetics

Ljubljana, 1000, Slovenia

Location

Study Officials

• Katja Žmitek

  Head of Research Group

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: January 22, 2019
• Study Start: March 4, 2019
• Primary Completion: July 2, 2019
• Study Completion: August 30, 2019
• Last Updated: September 3, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)