NCT02060097

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 11, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

June 14, 2016

Status Verified

June 1, 2016

Enrollment Period

1.1 years

First QC Date

February 9, 2014

Last Update Submit

June 11, 2016

Conditions

AgeingPhoto-aging

Keywords

Anti-agingHigh-flavanol cocoa

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in skin wrinkles at week 24

    Facial wrinkles in the crow's feet area measured as R1-3

    baseline, week 24

Secondary Outcomes (4)

  • Change from baseline in skin elasticity at week 24

    baseline, week 24

  • Change from baseline in minimal erythema dose at week 24

    baseline, week 24

  • Change from baseline in skin hydration at week 12

    baseline, week 12

  • Change from baseline in skin color at week 12

    baseline, week 12

Study Arms (2)

Cocoa flavanol beverage

ACTIVE COMPARATOR

flavanol 320mg/day

Dietary Supplement: Cocoa flavanol beverage

Placebo beverage

PLACEBO COMPARATOR

no flavanol

Dietary Supplement: Placebo beverage

Interventions

Cocoa flavanol beverageDIETARY_SUPPLEMENT
Also known as: High-flavanol cocoa
Cocoa flavanol beverage
Placebo beverageDIETARY_SUPPLEMENT
Placebo beverage

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy females aged ≥ 40 years
  • Facial wrinkle grade ≥ 2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110744, South Korea

Location

Related Publications (3)

  • Williams S, Tamburic S, Lally C. Eating chocolate can significantly protect the skin from UV light. J Cosmet Dermatol. 2009 Sep;8(3):169-73. doi: 10.1111/j.1473-2165.2009.00448.x.

    PMID: 19735513BACKGROUND

  • Heinrich U, Neukam K, Tronnier H, Sies H, Stahl W. Long-term ingestion of high flavanol cocoa provides photoprotection against UV-induced erythema and improves skin condition in women. J Nutr. 2006 Jun;136(6):1565-9. doi: 10.1093/jn/136.6.1565.

    PMID: 16702322BACKGROUND

  • Yoon HS, Kim JR, Park GY, Kim JE, Lee DH, Lee KW, Chung JH. Cocoa Flavanol Supplementation Influences Skin Conditions of Photo-Aged Women: A 24-Week Double-Blind, Randomized, Controlled Trial. J Nutr. 2016 Jan;146(1):46-50. doi: 10.3945/jn.115.217711. Epub 2015 Nov 18.

    PMID: 26581682DERIVED

Study Officials

  • Jin Ho Chung, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 9, 2014

First Posted

February 11, 2014

Study Start

February 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

June 14, 2016

Record last verified: 2016-06

Locations

KR(1)