Natreon Healthy Skin Study - PrimaVie Supplement

Study Overview
=================
Brief Summary
-----------------
This study will demonstrate the ability of the oral supplement, PrimaVie® to improve skin microperfusion, hydration, elasticity and barrier function. 45 females will be enrolled in 1 of 3 arms where they will receive either 125 mg PrimaVie, 250 mg PrimaVie or placebo (control) to take twice daily for 14 weeks.

Detailed Description
-----------------
Subjects will be assessed based on they type of Fitzpatrick skin type they have, will be return for a total of 6 study visits over 14 weeks where the following research activities will take place through the course of the study: medical/dietary history, medications will be recorded, supplement randomization based on one of the three arms will occur at study visit 1, and distribution of the study product will occur at all study visits, supplement tolerabiltity assessment, investigator and subject appearance assessment, photography of the face (left, right and front) will be taken, non-invasive assessments including Trans-epidermal Water Loss, hydration, elasticity, laser speckle perfusion, a skin biopsy of left inner upper arm (only at study visits 2 and 6), adverse event review, and supplement count/compliance review.

Official Title
-----------------
The Ability of an Oral Supplement to Improve Skin Microperfusion, Hydration, Elasticity, and Barrier Function

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: PrimaVie Herbal Supplement 125
* Dietary Supplement: PrimaVie Herbal Supplement 250
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects willing to discontinue any dietary or nutritional supplements, other than a general multivitamin, starting two weeks before onset of study and also during the study. Subjects must be willing to maintain their present diet with no major changes throughout the study. Subjects must be willing to take the dietary supplements as required by the study protocol twice daily. Female subjects must be between the ages of 30 to 65 years of age Subjects must provide written informed consent and are willing to comply with all study procedures. Exclusion Criteria: Any dermatological disorder that may interfere with the accurate evaluation of the subject's skin. Subjects who are pregnant, breast feeding, or planning a pregnancy. Clinically significant unstable medical disorders. History of, diabetes, heart or kidney disease History of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study. Any skin disease in the area of the upper inner arm where the biopsies will be obtained. Currently taking the following medications: Steroids Beta-blockers Immunosuppressant's Hydochlorothiazide, Statins Aspirin ACE Inhibitors Muscle relaxants Stimulants Prisoners Males

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

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks. | Dietary Supplement: PrimaVie Herbal Supplement 125<br>* 125 mg to take BID for 14 weeks in Arm 1<br>* Other names: PrimaVie;|
| Active Comparator: Arm 2<br>15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks. | Dietary Supplement: PrimaVie Herbal Supplement 250<br>* 250 mg to take BID for 14 weeks in Arm 2<br>* Other names: PrimaVie;|
| Placebo Comparator: Arm 3<br>15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks. | Drug: Placebo<br>* Placebo supplement to take BID for 14 weeks in Arm 3<br>* Other names: control supplement;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in non-invasive skin assessment of skin microperfusion | To see the improvement in noninvasive skin assessment of objective measurements such as skin microperfusion (laser speckle contrast imaging) (scale Pu) | 14 weeks after oral supplementation | 
| Improvement in non-invasive skin assessment of hydration | To see the improvement in noninvasive skin assessment of objective measurements such as skin hydration using the DermaLab Combo Series (unit of micro-Siemens uS) | 14 weeks after oral supplementation | 
| Improvement in non-invasive skin assessment of elasticity | To see the improvement in noninvasive skin assessment of objective measurements such as skin elasticity using the DermaLab Combo Series (mega Pascal mPa and ms units) | 14 weeks after oral supplementation | 
| Improvement in non-invasive skin assessment of barrier function | To see the improvement in noninvasive skin assessment of objective measurements such as barrier function using Trans-Epidermal Water Loss using the DermaLab Combo Series (g/m2/h) | 14 weeks after oral supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene Chip Analysis | identify the up or down regulation of key youthful skin markers (gene expression) produced by the supplement over the placebo as identified by gene chip analysis after 14 weeks of oral supplementation. | 14 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Skin Biopsy, PrimaVie, Herbal Supplement