Evaluation of Skin Attributes Following Dietary Supplement Consumption

Study Overview
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Brief Summary
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The study is to assess skin attributes of female subjects following 16 weeks of dietary supplement consumption.

Detailed Description
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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.

Official Title
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A Randomized, Double Blinded, Placebo Controlled Clinical Study to Evaluate Skin Attributes Following Dietary Supplement Consumption

Conditions
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Skin Condition

Intervention / Treatment
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* Dietary Supplement: Low dose Polyphenol
* Dietary Supplement: High dose Polyphenol
* Dietary Supplement: Placebo Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: individuals are assigned prospectively to two different interventions according to a protocol, to evaluate the effect of the interventions
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose Polyphenol<br>130 mg of Aronia Extract with 120 mg of licorice root combination blend provided to subjects once per day for 16 weeks. | Dietary Supplement: Low dose Polyphenol<br>* botanical supplement with 25 mg polyphenol<br>|
| Experimental: High dose Polyphenol<br>200 mg of Aronia extract provided to subjects once per day for 16 weeks | Dietary Supplement: High dose Polyphenol<br>* botanical supplement with 13 mg polyphenol<br>|
| Placebo Comparator: Placebo control<br>Inert tablet provided to subjects once per day for 16 weeks | Dietary Supplement: Placebo Control<br>* inert tablet made to mimic the experimental tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Skin Autofluoresence | Change of accumulation of glycation as measured by validated autofluoresence measuring device (AGE Reader) | Change from baseline to 16 weeks, change from 8 weeks to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin elasticity | Relationship between elasticity and skin glycation; elasticity will be measured by cutometer | Change from baseline to 16 weeks; change from 8 weeks to 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dicarbonyl compounds, skin elasticity, glycation