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Effects of Isoflavone Combined With Astaxanthin 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: NCT02373111
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : June 14, 2016
Sponsor:
Information provided by (Responsible Party):
Jin Ho Chung, Seoul National University Hospital

Study Description
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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) play a key role in UV-induced skin damage and diminish skin matrix protein levels, leading skin aging. Strategies utilizing endogenous skin antioxidants as well as plant-derived or synthetic compounds have been examined.

Astaxanthin mainly from marine algae and crustaceans is a kind of carotenoids which were well-known photo-protective agents with strong antioxidant activity. Several studies have revealed that supplementation of astaxanthin effectively protect skin against UV damage through free radicals.

In addition, matrix metalloproteinase-1 induced by UV irradiation is an important step toward skin aging. Recently, many studies pointed out that phytoestrogens exhibit agonistic and antagonistic estrogen activities, suppressing activity of MMP-1 in skin. Isoflavone is a kind of phytoestrogen from soybean and mainly act on skin and bones, inhibiting MMP-1 effectively.

The present study is designed to take isoflavone combined with astaxanthin to maximize their anti-aging ability and objectively measure the effects of the mixture on facial wrinkles, hydration, and elasticity.


Condition or disease Intervention/treatment Phase
Ageing Photo-aging Dietary Supplement: Isoflavone Dietary Supplement: Astaxanthin Dietary Supplement: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Isoflavone Combined With Astaxanthin on Skin Aging
Study Start Date : March 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Astaxanthin

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Isoflavone and Astaxanthin
Each subject takes one active tablet per day for 24 weeks. Each tablet contains isoflavone 27mg and astaxanthin 4mg.
 Dietary Supplement: Isoflavone
Dietary Supplement: Astaxanthin
Placebo Comparator: Placebo
Each subject takes one placebo tablet per day for 24 weeks.
 Dietary Supplement: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in skin wrinkles [ Time Frame: Twenty-four weeks ]
    Facial wrinkles in the crow's feet area measured by Skin Visiometer


Secondary Outcome Measures :
  1. Change from baseline in skin elasticity [ Time Frame: Twenty-four weeks ]
    Facial elasticity measured by Cutometer

  2. Change from baseline in epidermal hydration [ Time Frame: Twenty-four weeks ]
    Skin hydration measured by Corneometer

  3. Change from baseline in skin barrier integrity [ Time Frame: Tewnty-four weeks ]
    TEWL measured by Tewameter


Eligibility Criteria
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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy females aged ≥ 45 years
  • Facial wrinkle grade 2 to 4

Exclusion Criteria:

  • received medical or cosmetic treatment that interferes with the general aging process at least 3 months before the study
  • received any hormone replacement therapy at least 3 months before the study
  • reported taking functional foods more than 1 month during last 3 months before the study
  • history of acute or chronic disease such as severe liver or kidney disease
  • 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
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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): NCT02373111


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jin Ho Chung, MD, PhD Seoul National University Hospital
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Jin Ho Chung, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02373111    
Other Study ID Numbers: H-1412-144-637
First Posted: February 26, 2015    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
Isoflavones
Astaxanthine
Skin aging