The Effect of Green Tea and Vitamin C on Skin Health
Primary Purpose
Skin Cancer
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Green tea + vitamin C high dose
Placebo capsule
Sponsored by
About this trial
This is an interventional basic science trial for Skin Cancer focused on measuring Green tea, Vitamin C, Ultraviolet radiation, Inflammation, Photoageing
Eligibility Criteria
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
Sites / Locations
- Salford Royal NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Green tea + vit C high dose
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change in the minimum erythemal dose (MED) of ultraviolet radiation.
The UV minimum erythemal dose (MED) will be determined for each study volunteer before and after nutritional supplementation to examine if the intervention can increase the MED and therefore protect against UV-induced erythema.
Secondary Outcome Measures
Intergroup comparison of inflammatory mediators (cytokines/chemokines) in skin biopsy sections and blister fluid.
Intergroup comparison of histological biomarkers (leucocytes, markers of photoageing, DNA damage) in skin biopsy sections.
Nutrient (polyphenol) bioavailability in samples of skin, blood and urine.
Bioavailability will be assessed in volunteers participating in both the first (RCT) and second (non-randomised bioavailability) parts of the study.
Full Information
NCT ID
NCT01032031
First Posted
December 14, 2009
Last Updated
March 7, 2016
Sponsor
University of Manchester
Collaborators
University of Leeds, University of Bradford
1. Study Identification
Unique Protocol Identification Number
NCT01032031
Brief Title
The Effect of Green Tea and Vitamin C on Skin Health
Official Title
The Effect of Dietary Bioactive Compounds on Skin Health in Humans in Vivo
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manchester
Collaborators
University of Leeds, University of Bradford
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
There is little information on the effect of oral bioactive compounds on human skin clinically despite evidence of a beneficial effect from laboratory studies. The aim of this study is to examine the effect of oral bioactive compounds (green tea and vitamin C) on the health of human skin by measuring markers of skin health directly and skin nutrient uptake.
Detailed Description
There is little information on the effect of oral catechin, a nutritionally relevant bioactive compound, on skin health in humans in vivo despite considerable evidence for protective effects in experimental studies. Vitamin C is essential for skin health and stabilises catechins in the gut lumen. Ultraviolet radiation (UVR) in sunlight is a key environmental stressor impacting on skin health. Effects include acute inflammation and longer term photodamage.
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:
UVR-induced inflammation
Leukocyte infiltration
Inflammatory mediators
Markers of photoageing
DNA damage
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Cancer
Keywords
Green tea, Vitamin C, Ultraviolet radiation, Inflammation, Photoageing
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Green tea + vit C high dose
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Green tea + vitamin C high dose
Intervention Description
One green tea capsule (1250mg catechin) and one vitamin C tablet (100mg) daily for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo capsule
Intervention Description
One capsule daily for 3 months
Primary Outcome Measure Information:
Title
Change in the minimum erythemal dose (MED) of ultraviolet radiation.
Description
The UV minimum erythemal dose (MED) will be determined for each study volunteer before and after nutritional supplementation to examine if the intervention can increase the MED and therefore protect against UV-induced erythema.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Intergroup comparison of inflammatory mediators (cytokines/chemokines) in skin biopsy sections and blister fluid.
Time Frame
3 months
Title
Intergroup comparison of histological biomarkers (leucocytes, markers of photoageing, DNA damage) in skin biopsy sections.
Time Frame
3 months
Title
Nutrient (polyphenol) bioavailability in samples of skin, blood and urine.
Description
Bioavailability will be assessed in volunteers participating in both the first (RCT) and second (non-randomised bioavailability) parts of the study.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lesley E Rhodes, MBBS, MD
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Salford Royal NHS Foundation Trust
City
Manchester
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
23351338
Citation
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.
Results Reference
result
PubMed Identifier
26178731
Citation
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.
Results Reference
result
PubMed Identifier
26454512
Citation
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.
Results Reference
result
PubMed Identifier
25306116
Citation
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.
Results Reference
result
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The Effect of Green Tea and Vitamin C on Skin Health
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