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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Laval University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 September 22, 2014