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CompletedNCT01444625CHOCOPOUpdated May 29, 2013

Flavanols and Skin Photo Protection: a Clinical Trial

A Phase 2 interventional study of Flavanol-rich chocolate and Flavanol-free chocolate in Solar Skin Damage, sponsored by Laval University. Completed at 1 site in Canada. Open to female participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-29.

Sponsored by Laval University · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Solar Skin Damage

Keywords

  • UV radiation
  • photoprotection
  • flavanols rich chocolate
03

In context

Lead sponsor

Laval University is the lead sponsor of 371 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
78 participants (actual)

Study arms

  • Experimental
    Dark chocolate

    Flavanol-rich chocolate

    Other: Flavanol-rich chocolate

  • Placebo comparator
    Placebo chocolate

    Flavanol-free chocolate

    Other: Flavanol-free chocolate

Interventions

  • OtherFlavanol-rich chocolate

    High-flavanol chocolate, 12 weeks.

    Also known as: Experimental dark chocolate

  • OtherFlavanol-free chocolate

    Flavanol-free chocolate, 12 weeks

    Also known as: Placebo flavanol-free chocolate

06

What researchers measure

Primary outcomes

  1. Change in Minimal erythema dose

    Time frame: within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption

Secondary outcomes

  1. Change in Skin elasticity

    Time frame: within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption

  2. Change in Skin moisture

    Time frame: 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

    Time frame: within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption

07

Study locations

1 site
  • Laval university, Department of Medicine, Institut des nutraceutiques et des aliments fonctionnels.
    Québec, Quebec G1V 0A6, Canada
08

References and documents

Publications

  • Mogollon JA, Boivin C, Lemieux S, Blanchet C, Claveau J, Dodin S. Chocolate flavanols and skin photoprotection: a parallel, double-blind, randomized clinical trial. Nutr J. 2014 Jun 27;13:66. doi: 10.1186/1475-2891-13-66. PubMed 24970388 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01444625
Lead sponsor
Laval University
Responsible party
Claudine Blanchet (Coordinator, Laval University) — Principal investigator
First posted
Oct 3, 2011
Start date
Jun 2011
Primary completion
Sep 2012
Completion
May 2013
Last update
May 29, 2013

Study contacts

Sylvie Dodin, MD
principal investigator · Laval University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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