AgeingNCT02060097
Effects of Cocoa Flavanol on Skin Aging
A study testing Cocoa flavanol beverage in people with Ageing and Photo-aging, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Photoaging is caused by the superposition of chronic ultraviolet (UV)-induced damage on the intrinsic aging process, and accounts for the majority of age-associated changes in skin appearance. Reactive oxygen species (ROS) likely contribute to this process. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ageing, Photo-aging
- What is being tested?
- Cocoa flavanol beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2014to Mar 2015
- Phase
- Interventional
- 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 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy females aged ≥ 40 years
- Facial wrinkle grade ≥ 2
Who cannot join
- received medical or cosmetic treatment that interferes with the general aging process at least 3 months before the study
- reported taking functional foods 1 month before the study
- history of acute or chronic disease such as severe liver or kidney disease or uncontrolled diabetes
- history of allergies against any component of trial foods
- any visible skin disease that might be confused with a skin reaction to the test procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of 24-week Cocoa Flavanol Supplementation on Photo-aged Facial Skin
Photoaging is caused by the superposition of chronic ultraviolet (UV)-induced damage on the intrinsic aging process, and accounts for the majority of age-associated changes in skin appearance. Reactive oxygen species (ROS) likely contribute to this process. Strategies utilizing endogenous skin antioxidants as well as plant-derived or synthetic compounds have been examined.
Cocoa beans fresh from the tree are exceptionally rich in polyphenols, such as flavanol, and have a higher antioxidant capacity. The present study is designed to investigate the effects of long-term intake of a product rich in cocoa flavanols on facial wrinkles, hydration, elasticity and photosensitivity.
- Conditions
- Ageing, Photo-aging
- Being tested
- Cocoa flavanol beverage, Placebo beverage
- Keywords
- Anti-aging, High-flavanol cocoa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cocoa flavanol beverageDietary supplement
Also called High-flavanol cocoa
Placebo beverageDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Cocoa flavanol beverage | Active comparator | flavanol 320mg/day Receives: Dietary Supplement: Cocoa flavanol beverage |
| Placebo beverage | Placebo comparator | no flavanol Receives: Dietary Supplement: Placebo beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in skin wrinkles at week 24
Facial wrinkles in the crow's feet area measured as R1-3
Measured: baseline, week 24
Secondary outcomes (4)
Change from baseline in skin elasticity at week 24
Facial elasticity measured as R2, R5, R7
Measured: baseline, week 24
Change from baseline in minimal erythema dose at week 24
Measured: baseline, week 24
Change from baseline in skin hydration at week 12
Skin hydration measured by Corneometer
Measured: baseline, week 12
Change from baseline in skin color at week 12
Skin color measured as erythema index and melanin index
Measured: baseline, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AgeingStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Ho Chung, Seoul National University Hospital
- Investigators
- Jin Ho Chung, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060097
- Sponsor's protocol ID
- N0000697
- Status last verified
- Jun 2016
- First submitted
- 9 Feb 2014
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Williams S, Tamburic S, Lally C. Eating chocolate can significantly protect the skin from UV light. J Cosmet Dermatol. 2009 Sep;8(3):169-73. doi: 10.1111/j.1473-2165.2009.00448.x.
PubMed 19735513Heinrich U, Neukam K, Tronnier H, Sies H, Stahl W. Long-term ingestion of high flavanol cocoa provides photoprotection against UV-induced erythema and improves skin condition in women. J Nutr. 2006 Jun;136(6):1565-9. doi: 10.1093/jn/136.6.1565.
PubMed 16702322Yoon HS, Kim JR, Park GY, Kim JE, Lee DH, Lee KW, Chung JH. Cocoa Flavanol Supplementation Influences Skin Conditions of Photo-Aged Women: A 24-Week Double-Blind, Randomized, Controlled Trial. J Nutr. 2016 Jan;146(1):46-50. doi: 10.3945/jn.115.217711. Epub 2015 Nov 18.
PubMed 26581682
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 24-week Cocoa Flavanol Supplementation on Photo-aged Facial Skin
- ClinicalTrials.gov ID
- NCT02060097
- Acronym / sponsor ID
- N0000697
- Conditions
- Ageing, Photo-aging
- Keywords
- Anti-aging, High-flavanol cocoa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 11 Feb 2014 (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.
Photoaging is caused by the superposition of chronic ultraviolet (UV)-induced damage on the intrinsic aging process, and accounts for the majority of age-associated changes in skin appearance. Reactive oxygen species (ROS) likely contribute to this process. Strategies utilizing endogenous skin antioxidants as well as plant-derived or synthetic compounds have been examined.
Cocoa beans fresh from the tree are exceptionally rich in polyphenols, such as flavanol, and have a higher antioxidant capacity. The present study is designed to investigate the effects of long-term intake of a product rich in cocoa flavanols on facial wrinkles, hydration, elasticity and photosensitivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cocoa flavanol beverage | Active comparator | Dietary Supplement: Cocoa flavanol beverageflavanol 320mg/day |
| Placebo beverage | Placebo comparator | Dietary Supplement: Placebo beverageno flavanol |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy females aged ≥ 40 years
- Facial wrinkle grade ≥ 2
Key exclusion criteria (5 listed)
- received medical or cosmetic treatment that interferes with the general aging process at least 3 months before the study
- reported taking functional foods 1 month before the study
- history of acute or chronic disease such as severe liver or kidney disease or uncontrolled diabetes
- history of allergies against any component of trial foods
- any visible skin disease that might be confused with a skin reaction to the test procedure
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 |
|---|---|---|
| Cocoa flavanol beverageAlso: High-flavanol cocoa | Dietary supplement | Cocoa flavanol beverage |
| Placebo beverage | Dietary supplement | Placebo beverage |
Primary outcome
Change from baseline in skin wrinkles at week 24
Time frame: baseline, week 24
Facial wrinkles in the crow's feet area measured as R1-3
4 secondary outcomes
Change from baseline in skin elasticity at week 24
Time frame: baseline, week 24
Change from baseline in minimal erythema dose at week 24
Time frame: baseline, week 24
Change from baseline in skin hydration at week 12
Time frame: baseline, week 12
Change from baseline in skin color at week 12
Time frame: baseline, week 12
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 14 Jun 2016.
- Background: PubMed 19735513Williams S, Tamburic S, Lally C. Eating chocolate can significantly protect the skin from UV light. J Cosmet Dermatol. 2009 Sep;8(3):169-73. doi: 10.1111/j.1473-2165.2009.00448.x.
- Background: PubMed 16702322Heinrich U, Neukam K, Tronnier H, Sies H, Stahl W. Long-term ingestion of high flavanol cocoa provides photoprotection against UV-induced erythema and improves skin condition in women. J Nutr. 2006 Jun;136(6):1565-9. doi: 10.1093/jn/136.6.1565.
- Derived from this study: PubMed 26581682Yoon HS, Kim JR, Park GY, Kim JE, Lee DH, Lee KW, Chung JH. Cocoa Flavanol Supplementation Influences Skin Conditions of Photo-Aged Women: A 24-Week Double-Blind, Randomized, Controlled Trial. J Nutr. 2016 Jan;146(1):46-50. doi: 10.3945/jn.115.217711. Epub 2015 Nov 18.
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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.
Jin Ho Chung, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cocoa flavanol beverage in people with Ageing and Photo-aging, run by Seoul National University Hospital at 1 site in South Korea.
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 14 Jun 2016. 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 South Korea. 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.
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 from baseline in skin wrinkles at week 24 (time frame: baseline, week 24). 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 NCT02060097, which also lists 3 linked publications.
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 14 Jun 2016.