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

Dermis Density Clinical Trial

— VIST Lutein  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03811977
• Other study ID #: VIST F4F Lutein-MED 01-2018
• Status: Completed
• Phase: N/A
• Start date: March 4, 2019
• Est. completion date: August 30, 2019

Study information

• Verified date: January 2019
• Source: Higher School of Applied Sciences (VIST)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 30, 2019
• Est. primary completion date: July 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermis Density
• Erythema
• Minimal Erythema Dose
• Skin Viscoelasticity

Intervention

Dietary Supplement:
• Lutein syrup
12- week dietary supplementation with lutein syrup (20 mg lutein/day)
• Placebo syrup
12- week dietary supplementation with placebo syrup (0 mg lutein/day)

Locations

Country	Name	City	State
Slovenia	Higher School of Applied Sciences, Institute of Cosmetics	Ljubljana

Sponsors (6)

Lead Sponsor	Collaborator
Higher School of Applied Sciences (VIST)	Dermatologija Bartenjev Rogl, European Regional Development Fund, Ministry of Education, Science and Sport, Republic of Slovenia, Slovenian Research Agency, Valens Int. d.o.o., Slovenija

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	12 weeks
Secondary	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.	12 weeks