Flavanols and Skin Photo Protection: a Clinical Trial (CHOCOPO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Claudine Blanchet, Laval University
ClinicalTrials.gov Identifier:
NCT01444625
First received: September 26, 2011
Last updated: May 28, 2013
Last verified: May 2012
  Purpose

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 Intervention Phase
Solar Skin Damage
Other: Flavanol-rich chocolate
Other: Flavanol-free chocolate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Flavanols and Skin Photo Protection: a Double Blind Clinical Trial

Further study details as provided by Laval University:

Primary Outcome Measures:
  • Change in Minimal erythema dose [ Time Frame: within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Skin elasticity [ Time Frame: within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption ] [ Designated as safety issue: No ]
  • Change in Skin moisture [ Time Frame: within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 78
Study Start Date: June 2011
Study Completion Date: May 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dark chocolate
Flavanol-rich chocolate
Other: Flavanol-rich chocolate
High-flavanol chocolate, 12 weeks.
Other Name: Experimental dark chocolate
Placebo Comparator: Placebo chocolate
Flavanol-free chocolate
Other: Flavanol-free chocolate
Flavanol-free chocolate, 12 weeks
Other Name: Placebo flavanol-free chocolate

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01444625

Locations
Canada, Quebec
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
  More Information

No publications provided

Responsible Party: Claudine Blanchet, Coordinator, Laval University
ClinicalTrials.gov Identifier: NCT01444625     History of Changes
Other Study ID Numbers: Callebaut-10151, Callebaut-10151
Study First Received: September 26, 2011
Last Updated: May 28, 2013
Health Authority: Canada: Health Canada

Keywords provided by Laval University:
UV radiation
photoprotection
flavanols rich chocolate

ClinicalTrials.gov processed this record on April 23, 2014