Flavanols and Skin Photo Protection: a Clinical Trial
CHOCOPO
1 other identifier
interventional
78
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 26, 2011
CompletedFirst Posted
Study publicly available on registry
October 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedMay 29, 2013
May 1, 2012
1.3 years
September 26, 2011
May 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Minimal erythema dose
within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption
Secondary Outcomes (3)
Change in Skin elasticity
within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption
Change in Skin moisture
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
within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption
Study Arms (2)
Dark chocolate
EXPERIMENTALFlavanol-rich chocolate
Placebo chocolate
PLACEBO COMPARATORFlavanol-free chocolate
Interventions
High-flavanol chocolate, 12 weeks.
Flavanol-free chocolate, 12 weeks
Eligibility Criteria
You may qualify if:
- Non-smoking women between the ages of 20 and 65 years.
- Normal skin of type I and II as decried by Fitzpatrick classification.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laval Universitylead
Study Sites (1)
Laval university, Department of Medicine, Institut des nutraceutiques et des aliments fonctionnels.
Québec, Quebec, G1V 0A6, Canada
Related Publications (1)
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.
PMID: 24970388DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Sylvie Dodin, MD
Laval University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Coordinator
Study Record Dates
First Submitted
September 26, 2011
First Posted
October 3, 2011
Study Start
June 1, 2011
Primary Completion
September 1, 2012
Study Completion
May 1, 2013
Last Updated
May 29, 2013
Record last verified: 2012-05