Clinical trial NCT02762032: Natreon Healthy Skin Study - PrimaVie Supplement
Official title: The Ability of an Oral Supplement to Improve Skin Microperfusion, Hydration, Elasticity, and Barrier Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Keywords: Skin Biopsy
PrimaVie
Herbal Supplement
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Natreon, Inc.
First posted: 2016-05-04
Enrollment: 45
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Improvement in non-invasive skin assessment of skin microperfusion
timeFrame: 14 weeks after oral supplementation
measure: Improvement in non-invasive skin assessment of hydration
timeFrame: 14 weeks after oral supplementation
measure: Improvement in non-invasive skin assessment of elasticity
timeFrame: 14 weeks after oral supplementation
measure: Improvement in non-invasive skin assessment of barrier function
timeFrame: 14 weeks after oral supplementation
Secondary outcomes:
measure: Gene Chip Analysis
timeFrame: 14 weeks
Other outcomes:
measure: Subjective visual assessment by photographs
timeFrame: 14 weeks
Locations:
city: Columbus
country: United States
facility: OSU Hospital East
state: Ohio
city: Columbus
country: United States
facility: Davis Heart and Lung Research Institute
state: Ohio
city: Columbus
country: United States
facility: Martha Morehouse Medical Plaza 2050 Kenny Road
state: Ohio
Study officials:
affiliation: Ohio State University
name: Gayle M Gordillo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Das A, S El Masry M, Gnyawali SC, Ghatak S, Singh K, Stewart R, Lewis M, Saha A, Gordillo G, Khanna S. Skin Transcriptome of Middle-Aged Women Supplemented With Natural Herbo-mineral Shilajit Shows Induction of Microvascular and Extracellular Matrix Mechanisms. J Am Coll Nutr. 2019 Aug;38(6):526-536. doi: 10.1080/07315724.2018.1564088. Epub 2019 Jun 4.