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

May 28, 2013 updated by: Claudine Blanchet, Laval University

Flavanols and Skin Photo Protection: a Double Blind Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1V 0A6
        • Laval university, Department of Medicine, Institut des nutraceutiques et des aliments fonctionnels.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Minimal erythema dose
Time Frame: within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption
within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Skin elasticity
Time Frame: within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption
within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption
Change in Skin moisture
Time Frame: within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption
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
Time Frame: within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption
within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

September 26, 2011

First Submitted That Met QC Criteria

September 30, 2011

First Posted (Estimate)

October 3, 2011

Study Record Updates

Last Update Posted (Estimate)

May 29, 2013

Last Update Submitted That Met QC Criteria

May 28, 2013

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Callebaut-10151 (Other Identifier: Barry Callebaut Canada Inc)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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