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Completed

NCT Number: NCT02060097

Effects of Cocoa Flavanol on Skin Aging

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.

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Key information

Conditions

Ageing Photo-aging

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110744, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cocoa flavanol beverage

Dietary Supplement

Other names: High-flavanol cocoa

Placebo Beverage

Dietary Supplement

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 11, 2014
Registry last updated
Jun 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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