Clinical trial NCT02373111: Effects of Isoflavone Combined With Astaxanthin on Skin Aging
Official title: Effects of Isoflavone Combined With Astaxanthin on Skin Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ageing
Photo-aging
Keywords: Anti-aging
Isoflavones
Astaxanthine
Skin aging
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 90
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change from baseline in skin wrinkles
timeFrame: Twenty-four weeks
Secondary outcomes:
measure: Change from baseline in skin elasticity
timeFrame: Twenty-four weeks
measure: Change from baseline in epidermal hydration
timeFrame: Twenty-four weeks
measure: Change from baseline in skin barrier integrity
timeFrame: Tewnty-four weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin Ho Chung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: