- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02060097
Effects of Cocoa Flavanol on Skin Aging
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of, 110744
- Seoul National University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy females aged ≥ 40 years
- Facial wrinkle grade ≥ 2
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cocoa flavanol beverage
flavanol 320mg/day
|
Other Names:
|
Placebo Comparator: Placebo beverage
no flavanol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
baseline, week 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in skin elasticity at week 24
Time Frame: baseline, week 24
|
Facial elasticity measured as R2, R5, R7
|
baseline, week 24
|
Change from baseline in minimal erythema dose at week 24
Time Frame: baseline, week 24
|
baseline, week 24
|
|
Change from baseline in skin hydration at week 12
Time Frame: baseline, week 12
|
Skin hydration measured by Corneometer
|
baseline, week 12
|
Change from baseline in skin color at week 12
Time Frame: baseline, week 12
|
Skin color measured as erythema index and melanin index
|
baseline, week 12
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jin Ho Chung, MD, PhD, Seoul National University Hospital
Publications and helpful links
General Publications
- Heinrich 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.
- 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.
- Yoon 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- N0000697
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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