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


N/A
18 Years
65 Years
Not Enrolling
Both
Skin Cancer

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Trial Information

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


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. 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Outcome Measure:

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

Outcome 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.

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Lesley E Rhodes, MBBS, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Manchester

Authority:

United Kingdom: Research Ethics Committee

Study ID:

BB/G005575/1

NCT ID:

NCT01032031

Start Date:

March 2009

Completion Date:

August 2012

Related Keywords:

  • Skin Cancer
  • Green tea
  • Vitamin C
  • Ultraviolet radiation
  • Inflammation
  • Photoageing
  • Skin Neoplasms

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