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Completed

NCT Number: NCT01032031

The Effect of Green Tea and Vitamin C on Skin Health

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Salford Royal NHS Foundation Trust

Manchester, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Green tea + vitamin C high dose

Dietary Supplement

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

placebo capsule

Dietary Supplement

One capsule daily for 3 months

Primary outcomes

  1. Change in the minimum erythemal dose (MED) of ultraviolet radiation.

    Time frame: 3 months

    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 outcomes

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

    Time frame: 3 months

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

    Time frame: 3 months

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

    Time frame: 3 months

    Bioavailability will be assessed in volunteers participating in both the first (RCT) and second (non-randomised bioavailability) parts of the study.

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Collaborators

  • University of Bradford
  • University of Leeds

Registry information

Official study title

The Effect of Dietary Bioactive Compounds on Skin Health in Humans in Vivo

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Dec 15, 2009
Registry last updated
Mar 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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