Flavanols and Skin Photo Protection: a Clinical Trial

Solar Skin Damage Clinical Trial

— CHOCOPO  

Official title:

Flavanols and Skin Photo Protection: a Double Blind Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01444625
• Other study ID #: Callebaut-10151
• Secondary ID: Callebaut-10151
• Status: Completed
• Phase: Phase 2
• First received: September 26, 2011
• Last updated: May 28, 2013
• Start date: June 2011
• Est. completion date: May 2013

Study information

• Verified date: May 2012
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: May 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Solar Skin Damage

Intervention

Other:
• Flavanol-rich chocolate
High-flavanol chocolate, 12 weeks.
• Flavanol-free chocolate
Flavanol-free chocolate, 12 weeks

Locations

Country	Name	City	State
Canada	Laval university, Department of Medicine, Institut des nutraceutiques et des aliments fonctionnels.	Québec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Minimal erythema dose		within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption	No
Secondary	Change in Skin elasticity		within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption	No
Secondary	Change in Skin moisture		within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption	No
Secondary	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	No