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Trial record 6 of 7 for:    Open Studies | "Skin Aging"

Effects of Cocoa Flavanol on Skin Aging

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Jin Ho Chung, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT02060097
First received: February 9, 2014
Last updated: November 4, 2014
Last verified: November 2014
  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

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

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Change from baseline in skin wrinkles at week 24 [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Facial elasticity measured as R2, R5, R7

  • Change from baseline in minimal erythema dose at week 24 [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in skin hydration at week 12 [ Time Frame: baseline, week 12 ] [ Designated as safety issue: No ]
    Skin hydration measured by Corneometer

  • Change from baseline in skin color at week 12 [ Time Frame: baseline, week 12 ] [ Designated as safety issue: No ]
    Skin color measured as erythema index and melanin index


Estimated Enrollment: 64
Study Start Date: February 2014
Estimated 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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02060097

Contacts
Contact: Jin Ho Chung, MD, PhD 82-2-2072-2414 jhchung@snu.ac.kr

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

Publications:
Responsible Party: Jin Ho Chung, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02060097     History of Changes
Other Study ID Numbers: N0000697
Study First Received: February 9, 2014
Last Updated: November 4, 2014
Health Authority: Korea: Ministry of Food and Drug Safety

Keywords provided by Seoul National University Hospital:
Anti-aging
High-flavanol cocoa

ClinicalTrials.gov processed this record on November 27, 2014