4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / The Effect of 12-Week Dietary Intake of Lutein on Minimal Erythema Dose and Other Skin Parameters (VIST Lutein)

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

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.

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

Study Design
Layout table for study information
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
Arms and Interventions
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)
Outcome Measures
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.


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Locations
Layout table for location information
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
Layout table for investigator information
Study Director: Katja Žmitek Head of Research Group
Tracking Information
First Submitted Date  ICMJE January 17, 2019
First Posted Date  ICMJE January 22, 2019
Last Update Posted Date September 3, 2019
Actual Study Start Date  ICMJE March 4, 2019
Actual Primary Completion Date July 2, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of 12-Week Dietary Intake of Lutein on Minimal Erythema Dose and Other Skin Parameters
Official Title  ICMJE The Effect of 12-Week Dietary Intake of Lutein on Minimal Erythema Dose and Other Skin Parameters: Randomised Double-Blind Placebo Controlled Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Minimal Erythema Dose
  • Skin Viscoelasticity
  • Dermis Density
Intervention  ICMJE
  • Dietary Supplement: Lutein syrup
    12- week dietary supplementation with lutein syrup (20 mg lutein/day)
  • Dietary Supplement: Placebo syrup
    12- week dietary supplementation with placebo syrup (0 mg lutein/day)
Study Arms  ICMJE
  • 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.
    Intervention: Dietary Supplement: Lutein syrup
  • 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.
    Intervention: Dietary Supplement: Placebo syrup
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2019) 		30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 30, 2019
Actual Primary Completion Date July 2, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 25 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03811977
Other Study ID Numbers  ICMJE VIST F4F Lutein-MED 01-2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Higher School of Applied Sciences (VIST)
Study Sponsor  ICMJE Higher School of Applied Sciences (VIST)
Collaborators  ICMJE
  • 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  ICMJE
Study Director: Katja Žmitek Head of Research Group
PRS Account Higher School of Applied Sciences (VIST)
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯