The Effect of Green Tea and Vitamin C on Skin Health

NCT01032031 | Completed

• 2 other identifiers: BB/G005575/1UKCRN 6911
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Cancer

Keywords

Green tea; Vitamin C; Ultraviolet radiation; Inflammation; Photoageing

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (3)

• Intergroup comparison of inflammatory mediators (cytokines/chemokines) in skin biopsy sections and blister fluid.

  3 months

• Intergroup comparison of histological biomarkers (leucocytes, markers of photoageing, DNA damage) in skin biopsy sections.

  3 months

• Nutrient (polyphenol) bioavailability in samples of skin, blood and urine.

  3 months

Study Arms (2)

Green tea + vit C high dose

ACTIVE COMPARATOR

Dietary Supplement: Green tea + vitamin C high dose

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo capsule

Interventions

Green tea + vitamin C high dose DIETARY_SUPPLEMENT

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

Green tea + vit C high dose

Placebo capsule DIETARY_SUPPLEMENT

One capsule daily for 3 months

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults
• Sun-reactive skin type I / II

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manchester: lead
• University of Leeds: collaborator
• University of Bradford: collaborator

Study Sites (1)

Salford Royal NHS Foundation Trust

Manchester, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 23351338 RESULT

• 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.

  PMID: 26178731 RESULT

• 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.

  PMID: 26454512 RESULT

• 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.

  PMID: 25306116 RESULT

MeSH Terms

Conditions

Skin Neoplasms; Inflammation

Interventions

Tea; Ascorbic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Lesley E Rhodes, MBBS, MD

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Experimental Dermatology

Study Record Dates

• First Submitted: December 14, 2009
• First Posted: December 15, 2009
• Study Start: March 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: March 8, 2016

Record last verified: 2016-03

Locations

GB (1)