Natreon Healthy Skin Study - PrimaVie Supplement

Phase 1CompletedNCT02762032

Ohio State University45 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Healthy

Interventions

PrimaVie Herbal Supplement 125DIETARY_SUPPLEMENT

125 mg to take BID for 14 weeks in Arm 1

PrimaVie Herbal Supplement 250DIETARY_SUPPLEMENT

250 mg to take BID for 14 weeks in Arm 2

PlaceboDRUG

Placebo supplement to take BID for 14 weeks in Arm 3

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

OSU Hospital East

Columbus, Ohio, United States

Davis Heart and Lung Research Institute

Columbus, Ohio, United States

Martha Morehouse Medical Plaza 2050 Kenny Road

Columbus, Ohio, United States

Outcomes

Primary Outcomes

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). An increase in PU means improved perfusion of the skin.

Time frame: 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), which are arbitrary. An increase in uS means improved skin hydration and improved skin barrier function.

Time frame: 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). An increase in mPA means worsening of skin elasticity.

Time frame: 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 (TEWL) using the DermaLab Combo Series (g/m2/h). An increase in these units indicates a worsening of TEWL, and reduction of the barrier function of the skin.

Time frame: 14 weeks after oral supplementation

Data from ClinicalTrials.gov

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