Effects of Cocoa Flavanol on Skin Aging

Ageing Clinical Trial

Official title:

Effects of 24-week Cocoa Flavanol Supplementation on Photo-aged Facial Skin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02060097
• Other study ID #: N0000697
• 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

• Ageing
• Photo-aging

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