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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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5 November 2012 |
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Main ID: |
NCT01032031 |
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Date of registration:
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14/12/2009 |
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Primary sponsor: |
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Public title:
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The Effect of Green Tea and Vitamin C on Skin Health
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Scientific title:
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The Effect of Dietary Bioactive Compounds on Skin Health in Humans in Vivo |
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Date of first enrolment:
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March 2009 |
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Target sample size:
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95 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01032031 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Lesley E Rhodes, MBBS, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Manchester |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy adults
- Sun-reactive skin type I / II
Exclusion Criteria:
- History of skin cancer
- History of a photosensitivity disorder
- History of a generalised skin disorder
- Sunbathing (including sunbeds) in the past 3 months
- Pregnancy
- Taking photoactive medicine
- Drink tea > 2 cups/day
- Taking nutritional supplements
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Skin Cancer
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Intervention(s)
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Dietary Supplement: Green tea + vitamin C high dose
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Dietary Supplement: Placebo capsule
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Primary Outcome(s)
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Change in the minimum erythemal dose (MED) of ultraviolet radiation.
[Time Frame: 3 months]
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Secondary Outcome(s)
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Intergroup comparison of histological biomarkers (leucocytes, markers of photoageing) in skin biopsy sections.
[Time Frame: 3 months]
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Intergroup comparison of inflammatory mediators (cytokines/chemokines) in skin biopsy sections and blister fluid.
[Time Frame: 3 months]
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Nutrient (polyphenol) bioavailability in samples of skin, blood and urine.
[Time Frame: 3 months]
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Secondary ID(s)
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BB/G005575/1
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UKCRN 6911
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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