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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

Tracking Information
First Submitted Date  ICMJE February 9, 2014
First Posted Date  ICMJE February 11, 2014
Last Update Posted Date June 14, 2016
Study Start Date  ICMJE February 2014
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2014)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Cocoa Flavanol on Skin Aging
Official Title  ICMJE Effects of 24-week Cocoa Flavanol Supplementation on Photo-aged Facial Skin
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Ageing
  • Photo-aging
Intervention  ICMJE
  • Dietary Supplement: Cocoa flavanol beverage
    Other Name: High-flavanol cocoa
  • Dietary Supplement: Placebo beverage
Study Arms  ICMJE
  • Active Comparator: Cocoa flavanol beverage
    flavanol 320mg/day
    Intervention: Dietary Supplement: Cocoa flavanol beverage
  • Placebo Comparator: Placebo beverage
    no flavanol
    Intervention: Dietary Supplement: Placebo beverage
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 9, 2014)
64
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02060097
Other Study ID Numbers  ICMJE N0000697
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jin Ho Chung, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jin Ho Chung, MD, PhD Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP