Natreon Healthy Skin Study - PrimaVie Supplement

NCT02762032 | Unknown Phase 1

• 1 other identifier: DCS-71-14
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

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.

Conditions

Healthy

Keywords

Skin Biopsy; PrimaVie; Herbal Supplement

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Gene Chip Analysis

  14 weeks

Other Outcomes (1)

• Subjective visual assessment by photographs

  14 weeks

Study Arms (3)

Arm 1

ACTIVE COMPARATOR

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

Arm 2

ACTIVE COMPARATOR

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

Arm 3

PLACEBO COMPARATOR

15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks.

Drug: Placebo

Interventions

PrimaVie Herbal Supplement 125 DIETARY_SUPPLEMENT

125 mg to take BID for 14 weeks in Arm 1

Also known as: PrimaVie

Arm 1

PrimaVie Herbal Supplement 250 DIETARY_SUPPLEMENT

250 mg to take BID for 14 weeks in Arm 2

Also known as: PrimaVie

Arm 2

Placebo DRUG

Placebo supplement to take BID for 14 weeks in Arm 3

Also known as: control supplement

Arm 3

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead
• Natreon, Inc.: collaborator

Study Sites (3)

OSU Hospital East

Columbus, Ohio, 43205, United States

RECRUITING

Davis Heart and Lung Research Institute

Columbus, Ohio, 43210, United States

RECRUITING

Martha Morehouse Medical Plaza 2050 Kenny Road

Columbus, Ohio, 43221, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 31161927 DERIVED

Study Officials

• Gayle M Gordillo, M.D.

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth A Murphy, BS

CONTACT

9377283980; elizabeth.murphy@osumc.edu

Gayle M Gordillo, M.D.

CONTACT

614-293-8566; gayle.gordillo@osumc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: May 4, 2016
• Study Start: February 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: July 24, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)