Effects of Isoflavone Combined With Astaxanthin on Skin Aging

Ageing Clinical Trial

Official title:

Effects of Isoflavone Combined With Astaxanthin on Skin Aging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02373111
• Other study ID #: H-1412-144-637
• Status: Completed
• Phase: N/A
• First received: February 20, 2015
• Last updated: June 11, 2016
• Start date: March 2015
• Est. completion date: December 2015

Study information

• Verified date: June 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ageing
• Photo-aging

Intervention

Dietary Supplement:
• Isoflavone

• Astaxanthin

• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in skin wrinkles	Facial wrinkles in the crow's feet area measured by Skin Visiometer	Twenty-four weeks	No
Secondary	Change from baseline in skin elasticity	Facial elasticity measured by Cutometer	Twenty-four weeks	No
Secondary	Change from baseline in epidermal hydration	Skin hydration measured by Corneometer	Twenty-four weeks	No
Secondary	Change from baseline in skin barrier integrity	TEWL measured by Tewameter	Tewnty-four weeks	No