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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02060097
Other study ID # N0000697
Secondary ID
Status Completed
Phase N/A
First received February 9, 2014
Last updated June 11, 2016
Start date February 2014
Est. completion date March 2015

Study information

Verified date June 2016
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 40 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Cocoa flavanol beverage

Placebo beverage


Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in skin wrinkles at week 24 Facial wrinkles in the crow's feet area measured as R1-3 baseline, week 24 No
Secondary Change from baseline in skin elasticity at week 24 Facial elasticity measured as R2, R5, R7 baseline, week 24 No
Secondary Change from baseline in minimal erythema dose at week 24 baseline, week 24 No
Secondary Change from baseline in skin hydration at week 12 Skin hydration measured by Corneometer baseline, week 12 No
Secondary Change from baseline in skin color at week 12 Skin color measured as erythema index and melanin index baseline, week 12 No
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