The Effect of Green Tea and Vitamin C on Skin Health

NCT ID: NCT01032031

Last Updated: 2016-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-08-31

Brief Summary

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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

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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:

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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Skin Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Green tea + vit C high dose

Group Type ACTIVE_COMPARATOR

Green tea + vitamin C high dose

Intervention Type DIETARY_SUPPLEMENT

One green tea capsule (1250mg catechin) and one vitamin C tablet (100mg) daily for 3 months

Placebo

Group Type PLACEBO_COMPARATOR

Placebo capsule

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

Placebo capsule

One capsule daily for 3 months

Intervention Type DIETARY_SUPPLEMENT

Eligibility 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Leeds

OTHER

Sponsor Role collaborator

University of Bradford

OTHER

Sponsor Role collaborator

University of Manchester

OTHER

Sponsor Role lead

Responsible Party

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Lesley Rhodes

Professor of Experimental Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United Kingdom

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.

Reference Type RESULT
PMID: 23351338 (View on PubMed)

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.

Reference Type RESULT
PMID: 26178731 (View on PubMed)

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.

Reference Type RESULT
PMID: 26454512 (View on PubMed)

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.

Reference Type RESULT
PMID: 25306116 (View on PubMed)

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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