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Completed

NCT Number: NCT01444625

Flavanols and Skin Photo Protection: a Clinical Trial

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.

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Key information

Conditions

Solar Skin Damage

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Laval university, Department of Medicine, Institut des nutraceutiques et des aliments fonctionnels.

Québec, Quebec, G1V 0A6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Flavanol-rich chocolate

Other

High-flavanol chocolate, 12 weeks.

Other names: Experimental dark chocolate

Flavanol-free chocolate

Other

Flavanol-free chocolate, 12 weeks

Other names: Placebo flavanol-free chocolate

Primary outcomes

  1. Change in Minimal erythema dose

    Time frame: within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption

Secondary outcomes

  1. Change in Skin elasticity

    Time frame: within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption

  2. Change in Skin moisture

    Time frame: within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption

  3. Change in levels of Vitamin D and polyphenols

    Time frame: within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

Flavanols and Skin Photo Protection: a Double Blind Clinical Trial

Acronym: CHOCOPO

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Oct 3, 2011
Registry last updated
May 29, 2013

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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