Skin CancerNCT01032031
The Effect of Green Tea and Vitamin C on Skin Health
A study testing Green tea + vitamin C high dose in people with Skin Cancer, run by University of Manchester at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer
- What is being tested?
- Green tea + vitamin C high dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2009to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
- Sun-reactive skin type I / II
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Dietary Bioactive Compounds on Skin Health in Humans in Vivo
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.
Read the 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.
- Conditions
- Skin Cancer
- Being tested
- Green tea + vitamin C high dose, Placebo capsule
- Keywords
- Green tea, Vitamin C, Ultraviolet radiation, Inflammation, Photoageing
- Medical subject headings
- Skin Neoplasms, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green tea + vitamin C high doseDietary supplement
One green tea capsule (1250mg catechin) and one vitamin C tablet (100mg) daily for 3 months
Placebo capsuleDietary supplement
One capsule daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Green tea + vit C high dose | Active comparator | Not described Receives: Dietary Supplement: Green tea + vitamin C high dose |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (3)
Intergroup comparison of inflammatory mediators (cytokines/chemokines) in skin biopsy sections and blister fluid.
Measured: 3 months
Intergroup comparison of histological biomarkers (leucocytes, markers of photoageing, DNA damage) in skin biopsy sections.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startMar 2009
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leeds, University of Bradford
- Responsible party
- Principal investigator, Lesley Rhodes, University of Manchester
- Investigators
- Lesley E Rhodes, MBBS, MD, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032031
- Sponsor's protocol ID
- BB/G005575/1
- Other IDs
- UKCRN 6911
- Status last verified
- Mar 2016
- First submitted
- 14 Dec 2009
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23351338Farrar 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.
PubMed 26178731Clarke 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.
PubMed 26454512Clarke 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.
PubMed 25306116
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dietary Bioactive Compounds on Skin Health in Humans in Vivo
- ClinicalTrials.gov ID
- NCT01032031
- Acronym / sponsor ID
- BB/G005575/1
- Conditions
- Skin Cancer
- Keywords
- Green tea, Vitamin C, Ultraviolet radiation, Inflammation, Photoageing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- University of Leeds, University of Bradford
- Study start
- Mar 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 15 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Green tea + vit C high dose | Active comparator | Dietary Supplement: Green tea + vitamin C high dose |
| Placebo | Placebo comparator | Dietary Supplement: Placebo capsule |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adults
- Sun-reactive skin type I / II
Key exclusion criteria (8 listed)
- History of skin cancer
- History of a photosensitivity disorder
- History of a generalised skin disorder
- Sunbathing (including sunbeds) in the past 3 months
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Green tea + vitamin C high doseOne green tea capsule (1250mg catechin) and one vitamin C tablet (100mg) daily for 3 months | Dietary supplement | Green tea + vit C high dose |
| Placebo capsuleOne capsule daily for 3 months | Dietary supplement | Placebo |
Primary outcome
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.
3 secondary outcomes
Intergroup comparison of inflammatory mediators (cytokines/chemokines) in skin biopsy sections and blister fluid.
Time frame: 3 months
Intergroup comparison of histological biomarkers (leucocytes, markers of photoageing, DNA damage) in skin biopsy sections.
Time frame: 3 months
Nutrient (polyphenol) bioavailability in samples of skin, blood and urine.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
- Results publication: PubMed 23351338Rhodes 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 publication: PubMed 26178731Farrar 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 publication: PubMed 26454512Clarke 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 publication: PubMed 25306116Clarke 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lesley E Rhodes, MBBS, MD principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Green tea + vitamin C high dose in people with Skin Cancer, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the minimum erythemal dose (MED) of ultraviolet radiation. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01032031, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016.