Flavanols and Skin Photo Protection: a Clinical Trial

Phase 2

Completed

• Conditions: Solar Skin Damage
• Interventions: Other: Flavanol-rich chocolate; Other: Flavanol-free chocolate

• Registration Number: NCT01444625
• Lead Sponsor: Laval University

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-09-26
• Study First Submitted QC: 2011-09-30
• Study First Posted: 2011-10-03
• Status Verified: 2012-05
• Primary Completion: 2012-09
• Study Completion: 2013-05
• Last Update Submitted: 2013-05-28
• Last Update Posted: 2013-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 78

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dark chocolate	Flavanol-rich chocolate	Flavanol-rich chocolate
Placebo chocolate	Flavanol-free chocolate	Flavanol-free chocolate

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Laval university, Department of Medicine, Institut des nutraceutiques et des aliments fonctionnels.; 🇨🇦 Québec, Quebec, Canada