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| Name | Class |
|---|---|
| Clinical Research Laboratories | UNKNOWN |
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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-CRâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose Polyphenol | Experimental | 130 mg of Aronia Extract with 120 mg of licorice root combination blend provided to subjects once per day for 16 weeks. |
|
| High dose Polyphenol | Experimental | 200 mg of Aronia extract provided to subjects once per day for 16 weeks |
|
| Placebo control | Placebo Comparator | Inert tablet provided to subjects once per day for 16 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose Polyphenol | Dietary Supplement | botanical supplement with 25 mg polyphenol |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anita L Cham, MD | Clinical Research Laboraties, LLC | Principal Investigator |
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| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D059808 | Polyphenols |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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individuals are assigned prospectively to two different interventions according to a protocol, to evaluate the effect of the interventions
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Interventions coded, blinded code kept in sealed envelope until study closed
| High dose Polyphenol |
| Dietary Supplement |
botanical supplement with 13 mg polyphenol |
|
| Placebo Control | Dietary Supplement | inert tablet made to mimic the experimental tablets |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |