CHOCOPO: Flavanols and Skin Photo Protection: a Clinical Trial

• Sponsor: Laval University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01444625
• Collaborator: (none)
• Enrollment: 78
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 3.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solar Skin Damage	Other: Flavanol-rich chocolate; Other: Flavanol-free chocolate	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Flavanols and Skin Photo Protection: a Double Blind Clinical Trial
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dark chocolate Flavanol-rich chocolate	Other: Flavanol-rich chocolate; High-flavanol chocolate, 12 weeks.; Other Names: Experimental dark chocolate
Placebo Comparator: Placebo chocolate Flavanol-free chocolate	Other: Flavanol-free chocolate; Flavanol-free chocolate, 12 weeks; Other Names: Placebo flavanol-free chocolate

Outcome Measures

Primary Outcome Measures

1. 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

1. Change in Skin elasticity [within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption]

2. Change in Skin moisture [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 [within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laval university, Department of Medicine, Institut des nutraceutiques et des aliments fonctionnels.	Québec	Quebec	Canada	G1V 0A6

Sponsors and Collaborators

• Laval University

Investigators

• Principal Investigator: Sylvie Dodin, MD, Laval University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Claudine Blanchet, Coordinator, Laval University
• ClinicalTrials.gov Identifier: NCT01444625
• Other Study ID Numbers: Callebaut-10151; Callebaut-10151
• First Posted: Oct 3, 2011
• Last Update Posted: May 29, 2013
• Last Verified: May 1, 2012

• Keywords provided by Claudine Blanchet, Coordinator, Laval University: UV radiation; photoprotection; flavanols rich chocolate

Study Results

No Results Posted as of May 29, 2013