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

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ClinicalTrials.gov Identifier: NCT03811977
Recruitment Status : Completed
First Posted : January 21, 2019
Last Update Posted : September 2, 2019
Sponsor:
Collaborators:
European Regional Development Fund
Ministry of Education, Science and Sport, Republic of Slovenia
Dermatologija Bartenjev Rogl
Slovenian Research Agency
Valens Int. d.o.o., Slovenija
Information provided by (Responsible Party):
Higher School of Applied Sciences (VIST)

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.

Condition or disease Intervention/treatment Phase
Minimal Erythema Dose Skin Viscoelasticity Dermis Density Dietary Supplement: Lutein syrup Dietary Supplement: Placebo syrup Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 4, 2019
Actual Primary Completion Date : July 2, 2019
Actual Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Lutein

Arm Intervention/treatment
Experimental: 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.
Dietary Supplement: Lutein syrup
12- week dietary supplementation with lutein syrup (20 mg lutein/day)

Placebo Comparator: 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.
Dietary Supplement: Placebo syrup
12- week dietary supplementation with placebo syrup (0 mg lutein/day)




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03811977


Locations
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Slovenia
Higher School of Applied Sciences, Institute of Cosmetics
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
Higher School of Applied Sciences (VIST)
European Regional Development Fund
Ministry of Education, Science and Sport, Republic of Slovenia
Dermatologija Bartenjev Rogl
Slovenian Research Agency
Valens Int. d.o.o., Slovenija
Investigators
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Study Director: Katja Žmitek Head of Research Group

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Responsible Party: Higher School of Applied Sciences (VIST)
ClinicalTrials.gov Identifier: NCT03811977     History of Changes
Other Study ID Numbers: VIST F4F Lutein-MED 01-2018
First Posted: January 21, 2019    Key Record Dates
Last Update Posted: September 2, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Erythema
Skin Diseases
Skin Manifestations
Signs and Symptoms