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NCT Number: NCT03811977

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

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.

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Key information

Age range

25 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Higher School of Applied Sciences, Institute of Cosmetics

Ljubljana, 1000, Slovenia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lutein syrup

Dietary Supplement

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

Placebo syrup

Dietary Supplement

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

Primary outcomes

  1. Photoprotective potential of the investigational product in relation to placebo product assessed through measurements of minimal erythema dose

    Time frame: 12 weeks

    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.

Secondary outcomes

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

    Time frame: 12 weeks

    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.

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

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

VIST - Faculty of Applied Sciences

Other

Collaborators

  • Dermatologija Bartenjev Rogl
  • European Regional Development Fund
  • Ministry of Higher Education, Science and Technology, Solvenia
  • Slovenian Research Agency
  • Valens Int. d.o.o., Slovenija

Registry information

Official study title

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

Acronym: VIST Lutein

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 22, 2019
Registry last updated
Sep 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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