Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Cocoa Flavanol on Skin Aging

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.
 
ClinicalTrials.gov Identifier: NCT02060097
Recruitment Status : Completed
First Posted : February 11, 2014
Last Update Posted : June 14, 2016
Sponsor:
Information provided by (Responsible Party):
Jin Ho Chung, Seoul National University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease Intervention/treatment Phase
Ageing Photo-aging Dietary Supplement: Cocoa flavanol beverage Dietary Supplement: Placebo beverage Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
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
Study Start Date : February 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 :
  1. Change from baseline in skin elasticity at week 24 [ Time Frame: baseline, week 24 ]
    Facial elasticity measured as R2, R5, R7

  2. Change from baseline in minimal erythema dose at week 24 [ Time Frame: baseline, week 24 ]
  3. Change from baseline in skin hydration at week 12 [ Time Frame: baseline, week 12 ]
    Skin hydration measured by Corneometer

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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Jin Ho Chung, MD, PhD Seoul National University Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Jin Ho Chung, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02060097    
Other Study ID Numbers: N0000697
First Posted: February 11, 2014    Key Record Dates
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