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Effects of Cocoa Flavanol on Skin Aging

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02060097
First Posted: February 11, 2014
Last Update Posted: June 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jin Ho Chung, Seoul National University Hospital
  Purpose

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.


Condition Intervention
Ageing Photo-aging Dietary Supplement: Cocoa flavanol beverage Dietary Supplement: Placebo beverage

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of 24-week Cocoa Flavanol Supplementation on Photo-aged Facial Skin

Further study details as provided by Jin Ho Chung, Seoul National University Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Change from baseline in skin elasticity at week 24 [ Time Frame: baseline, week 24 ]
    Facial elasticity measured as R2, R5, R7

  • 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 ]
    Skin hydration measured by Corneometer

  • Change from baseline in skin color at week 12 [ Time Frame: baseline, week 12 ]
    Skin color measured as erythema index and melanin index


Enrollment: 64
Study Start Date: February 2014
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cocoa flavanol beverage
flavanol 320mg/day
Dietary Supplement: Cocoa flavanol beverage
Other Name: High-flavanol cocoa
Placebo Comparator: Placebo beverage
no flavanol
Dietary Supplement: Placebo beverage

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060097


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Jin Ho Chung, MD, PhD Seoul National University Hospital
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jin Ho Chung, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02060097     History of Changes
Other Study ID Numbers: N0000697
First Submitted: February 9, 2014
First Posted: February 11, 2014
Last Update Posted: June 14, 2016
Last Verified: June 2016

Keywords provided by Jin Ho Chung, Seoul National University Hospital:
Anti-aging
High-flavanol cocoa