Flavanols and Skin Photo Protection: a Clinical Trial

Study Overview
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Brief Summary
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As flavanols have antioxidants, anti-inflammatory and anti-DNA damaging effects and may increase microcirculation in skin, the purpose of the study is to investigate the chronic effect of flavanol-rich chocolate as an effective strategy to protect against the harmful effect of ultraviolet (UV) radiation.

Detailed Description
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Recent data suggested that chronic ingestion of high flavanols cocoa might be a promising agent for dietary photo protection against UV light. Moreover, flavanols-rich cocoa intake has been shown to increase microcirculation in human skin.

Official Title
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Flavanols and Skin Photo Protection: a Double Blind Clinical Trial

Conditions
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Solar Skin Damage

Intervention / Treatment
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* Other: Flavanol-rich chocolate
* Other: Flavanol-free chocolate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-smoking women between the ages of 20 and 65 years. Normal skin of type I and II as decried by Fitzpatrick classification. Exclusion Criteria: Pregnancy and breast feeding. Photo sensibility: history of skin cancers, photosensitizing medication. Sun bed use or sunbathing in the previous 3 months. Use of supplements or natural health products (fish oils, coenzyme Q10, garlic, lycopene, beta carotene). Allergy or intolerance to nuts or chocolate.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dark chocolate<br>Flavanol-rich chocolate | Other: Flavanol-rich chocolate<br>* High-flavanol chocolate, 12 weeks.<br>* Other names: Experimental dark chocolate;|
| Placebo Comparator: Placebo chocolate<br>Flavanol-free chocolate | Other: Flavanol-free chocolate<br>* Flavanol-free chocolate, 12 weeks<br>* Other names: Placebo flavanol-free chocolate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Minimal erythema dose |  | within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Skin elasticity |  | within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption | 
| Change in Skin moisture |  | within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption | 
| Change in levels of Vitamin D and polyphenols |  | within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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UV radiation, photoprotection, flavanols rich chocolate