evaluation of skin attributes following dietary supplement consumption

Conditions: Skin Condition

Summary: the study is to assess skin attributes of female subjects following 16 weeks of dietary supplement consumption.

this is a 16 week, randomized, double blind, placebo controlled study. approximately 105 caucasian and asian (korean, japanese, or chinese) female subjects will be enrolled. the following clinical assessments will be performed: (1)visia-cr™ digital photography; (2)age reader su measurements on the left cheek and left inner forearm; (3) visual analog grading (vas); (4) corneometer measurements; and (5) cutometer measurements. subjects will return to the clinic at approximately 4 weeks, 8 weeks and 16 weeks from the baseline visit for similar measurements. a self-perception questionnaire will be administered at the conclusion of the study.

Eligibility criteria:
inclusion criteria: * subject is a caucasian or asian (either korean, japanese, or chinese) female between the ages of 30 and 65 years; * subject is overweight or moderately obese, with a bmi between 27 and 33; * subject is caucasian and qualifies based on age reader assessment that is at or greater than average for chronological age; or is asian and has an obtainable age reader assessment on the left forearm. screening age reader assessment will be done on the left inner forearm; * subject is willing to have fasting blood draws and urine collections at specified visits. at least nine hours fasting is required. subject is allowed to drink water; * subject is willing to refrain from excessive sun exposure and/or the use of tanning beds; * subject is willing to use daily the provided facial spf moisturizer and purpose® cleansing bar; * subject is taking well established, stable doses of prescription and nonprescription medications not indicated to treat a thyroid condition or diabetes; * subject is in generally good health as determined by the medical history and blood panel results in the opinion of the principal investigator; * subject is dependable and able to follow directions as outlined in the protocol; * subject agrees to complete and sign a photography release form, providing consent for the capture of facial digital images for use in relation to this clinical study; * subject has completed a hipaa authorization form in conformance with 45 cfr parts 160 and 164; * subject understands and is willing to sign an informed consent in conformance with 21 cfr part 50: "protection of human subjects." exclusion criteria: * subject is pregnant, planning to become pregnant, or nursing; * subject is known to have, or at risk for, photosensitivity reactions (e.g. very sensitive to ultraviolet light); * subject has scars, tattoos, moles, age spots or rashes on the tested areas that the age reader sensor and cutometer® probe need to be placed; * subject takes prescription anticoagulants (this does not include a daily 81 mg dose of aspirin); * subject has a history of any type of cancer and/or is currently undergoing treatment for any type of cancer; * subject has either a systolic blood pressure above 160 or a diastolic blood pressure above 100 at any time during the study; * subject has a thyroid condition; * subject is diabetic or taking any medication or herbal supplement to lower their blood glucose

Keywords: dicarbonyl compounds skin elasticity glycation