Study Results
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Basic Information
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COMPLETED
NA
95 participants
INTERVENTIONAL
2009-03-31
2012-08-31
Brief Summary
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Detailed Description
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OBJECTIVE: To examine the protective effect of catechin and vitamin C on UVR-induced inflammation.
STUDY DESIGN
(1) A double-blind randomised controlled nutritional study in 50 healthy volunteers. Volunteers will receive 3 months dietary supplement with high dose bioactive (n=25),or placebo (n=25).
The aim is to quantify the influence of catechin/vitamin C on:
1. UVR-induced inflammation
2. Leukocyte infiltration
3. Inflammatory mediators
4. Markers of photoageing
5. DNA damage
6. Bioavailability will also be assessed
(2) Bioavailability of catechin and vitamin C in skin and blood. Volunteers will receive active dietary supplement. Blood and urine samples will be taken over a period of 6 hours to determine blood bioavailability. Skin biopsies will also be taken to assess skin bioavailability. Volunteers will then receive 3 months of active dietary supplement followed by repeated sampling.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Green tea + vit C high dose
Green tea + vitamin C high dose
One green tea capsule (1250mg catechin) and one vitamin C tablet (100mg) daily for 3 months
Placebo
Placebo capsule
One capsule daily for 3 months
Interventions
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Green tea + vitamin C high dose
One green tea capsule (1250mg catechin) and one vitamin C tablet (100mg) daily for 3 months
Placebo capsule
One capsule daily for 3 months
Eligibility Criteria
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Inclusion Criteria
* Sun-reactive skin type I / II
Exclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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University of Leeds
OTHER
University of Bradford
OTHER
University of Manchester
OTHER
Responsible Party
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Lesley Rhodes
Professor of Experimental Dermatology
Principal Investigators
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Lesley E Rhodes, MBBS, MD
Role: PRINCIPAL_INVESTIGATOR
University of Manchester
Locations
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Salford Royal NHS Foundation Trust
Manchester, , United Kingdom
Countries
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References
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Rhodes LE, Darby G, Massey KA, Clarke KA, Dew TP, Farrar MD, Bennett S, Watson RE, Williamson G, Nicolaou A. Oral green tea catechin metabolites are incorporated into human skin and protect against UV radiation-induced cutaneous inflammation in association with reduced production of pro-inflammatory eicosanoid 12-hydroxyeicosatetraenoic acid. Br J Nutr. 2013 Sep 14;110(5):891-900. doi: 10.1017/S0007114512006071. Epub 2013 Jan 28.
Farrar MD, Nicolaou A, Clarke KA, Mason S, Massey KA, Dew TP, Watson RE, Williamson G, Rhodes LE. A randomized controlled trial of green tea catechins in protection against ultraviolet radiation-induced cutaneous inflammation. Am J Clin Nutr. 2015 Sep;102(3):608-15. doi: 10.3945/ajcn.115.107995. Epub 2015 Jul 15.
Clarke KA, Dew TP, Watson RE, Farrar MD, Osman JE, Nicolaou A, Rhodes LE, Williamson G. Green tea catechins and their metabolites in human skin before and after exposure to ultraviolet radiation. J Nutr Biochem. 2016 Jan;27:203-10. doi: 10.1016/j.jnutbio.2015.09.001. Epub 2015 Sep 12.
Clarke KA, Dew TP, Watson RE, Farrar MD, Bennett S, Nicolaou A, Rhodes LE, Williamson G. High performance liquid chromatography tandem mass spectrometry dual extraction method for identification of green tea catechin metabolites excreted in human urine. J Chromatogr B Analyt Technol Biomed Life Sci. 2014 Dec 1;972:29-37. doi: 10.1016/j.jchromb.2014.09.035. Epub 2014 Sep 30.
Other Identifiers
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UKCRN 6911
Identifier Type: REGISTRY
Identifier Source: secondary_id
BB/G005575/1
Identifier Type: -
Identifier Source: org_study_id
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