Solar Skin DamagePhase 2CHOCOPONCT01444625
Flavanols and Skin Photo Protection: a Clinical Trial
A Phase 2 study testing Flavanol-rich chocolate and Flavanol-free chocolate in people with Solar Skin Damage, run by Laval University at 1 site in Canada.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Solar Skin Damage
- What is being tested?
- Flavanol-rich chocolate and Flavanol-free chocolate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2011to May 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-smoking women between the ages of 20 and 65 years.
- Normal skin of type I and II as decried by Fitzpatrick classification.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Laval university, Department of Medicine, Institut des nutraceutiques et des aliments fonctionnels.
Québec, Quebec, G1V 0A6
About this study
Official title: 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.
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.
- Conditions
- Solar Skin Damage
- Being tested
- Flavanol-rich chocolate, Flavanol-free chocolate
- Keywords
- UV radiation, photoprotection, flavanols rich chocolate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flavanol-rich chocolateOther
Also called Experimental dark chocolate
High-flavanol chocolate, 12 weeks.
Flavanol-free chocolateOther
Also called Placebo flavanol-free chocolate
Flavanol-free chocolate, 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dark chocolate | Experimental | Flavanol-rich chocolate Receives: Other: Flavanol-rich chocolate |
| Placebo chocolate | Placebo comparator | Flavanol-free chocolate Receives: Other: Flavanol-free chocolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Minimal erythema dose
Measured: within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption
Secondary outcomes (3)
Change in Skin elasticity
Measured: within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption
Change in Skin moisture
Measured: 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
Measured: within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2011 (estimated)
- Study startJun 2011
- Primary completionSep 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solar Skin DamageStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudine Blanchet, Laval University
- Investigators
- Sylvie Dodin, MD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444625
- Sponsor's protocol ID
- Callebaut-10151
- Other IDs
- Callebaut-10151
- Acronym
- CHOCOPO
- Status last verified
- May 2012
- First submitted
- 26 Sep 2011
- Last updated
- 29 May 2013
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flavanols and Skin Photo Protection: a Double Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT01444625
- Acronym / sponsor ID
- CHOCOPO / Callebaut-10151
- Conditions
- Solar Skin Damage
- Keywords
- UV radiation, photoprotection, flavanols rich chocolate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 3 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dark chocolate | Experimental | Other: Flavanol-rich chocolateFlavanol-rich chocolate |
| Placebo chocolate | Placebo comparator | Other: Flavanol-free chocolateFlavanol-free chocolate |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Non-smoking women between the ages of 20 and 65 years.
- Normal skin of type I and II as decried by Fitzpatrick classification.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flavanol-rich chocolateAlso: Experimental dark chocolateHigh-flavanol chocolate, 12 weeks. | Other | Dark chocolate |
| Flavanol-free chocolateAlso: Placebo flavanol-free chocolateFlavanol-free chocolate, 12 weeks | Other | Placebo chocolate |
Primary outcome
Change in Minimal erythema dose
Time frame: within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption
3 secondary outcomes
Change in Skin elasticity
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2013.
- Derived from this study: PubMed 24970388Mogollon 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.
Related trials for Solar Skin Damage
RecruitingObservational study
Melanoma of the Skin and Exposure to Solar Ultraviolet Radiation at Work in Modena Territory: a Case-control Study to Promote an Active Search and Prevention of Occupational Diseases Based on Recent INAIL Criteria
Skin Melanoma, Cutaneous Melanoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie Dodin, MD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Flavanol-rich chocolate and Flavanol-free chocolate in people with Solar Skin Damage, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Minimal erythema dose (time frame: within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01444625, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2013.