Flavanols and Skin Photo Protection: a Clinical Trial

NCT ID: NCT01444625

Last Updated: 2013-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Solar Skin Damage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dark chocolate

Flavanol-rich chocolate

Group Type EXPERIMENTAL

Flavanol-rich chocolate

Intervention Type OTHER

High-flavanol chocolate, 12 weeks.

Placebo chocolate

Flavanol-free chocolate

Group Type PLACEBO_COMPARATOR

Flavanol-free chocolate

Intervention Type OTHER

Flavanol-free chocolate, 12 weeks

Interventions

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Flavanol-rich chocolate

High-flavanol chocolate, 12 weeks.

Intervention Type OTHER

Flavanol-free chocolate

Flavanol-free chocolate, 12 weeks

Intervention Type OTHER

Other Intervention Names

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Experimental dark chocolate Placebo flavanol-free chocolate

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Laval University

OTHER

Sponsor Role lead

Responsible Party

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Claudine Blanchet

Coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sylvie Dodin, MD

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

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Laval university, Department of Medicine, Institut des nutraceutiques et des aliments fonctionnels.

Québec, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 24970388 (View on PubMed)

Other Identifiers

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Callebaut-10151

Identifier Type: OTHER

Identifier Source: secondary_id

Callebaut-10151

Identifier Type: -

Identifier Source: org_study_id

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