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

Primary Purpose

Minimal Erythema Dose, Skin Viscoelasticity, Dermis Density

Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Lutein syrup
Placebo syrup
Sponsored by
VIST - Faculty of Applied Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Minimal Erythema Dose

Eligibility Criteria

25 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Higher School of Applied Sciences, Institute of Cosmetics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Test group

Placebo group

Arm Description

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.

Placebo group will receive placebo product - placebo syrup (lutein 0 mg/mL; daily dose 0 mg). Continuous administration of placebo product for 12 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 17, 2019
Last Updated
August 30, 2019
Sponsor
VIST - Faculty of Applied Sciences
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
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1. Study Identification

Unique Protocol Identification Number
NCT03811977
Brief Title
The Effect of 12-Week Dietary Intake of Lutein on Minimal Erythema Dose and Other Skin Parameters
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 4, 2019 (Actual)
Primary Completion Date
July 2, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VIST - Faculty of Applied Sciences
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Minimal Erythema Dose, Skin Viscoelasticity, Dermis Density

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo group will receive placebo product - placebo syrup (lutein 0 mg/mL; daily dose 0 mg). Continuous administration of placebo product for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Lutein syrup
Intervention Description
12- week dietary supplementation with lutein syrup (20 mg lutein/day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo syrup
Intervention Description
12- week dietary supplementation with placebo syrup (0 mg lutein/day)
Primary Outcome Measure Information:
Title
Photoprotective potential of the investigational product in relation to placebo product assessed through measurements of minimal erythema dose
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Influence of investigational product in relation to placebo product on dermis density assessed through dermis intensity measurement
Description
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.
Time Frame
12 weeks
Title
Influence of the investigational product in relation to placebo product on skin elasticity assessed through measurements of viscoelasticity
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katja Žmitek
Organizational Affiliation
Head of Research Group
Official's Role
Study Director
Facility Information:
Facility Name
Higher School of Applied Sciences, Institute of Cosmetics
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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