Natreon Healthy Skin Study - PrimaVie Supplement

July 20, 2017 updated by: Gayle Gordillo, Ohio State University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Davis Heart and Lung Research Institute
        • Contact:
      • Columbus, Ohio, United States, 43221
        • Recruiting
        • Martha Morehouse Medical Plaza 2050 Kenny Road
        • Contact:
        • Principal Investigator:
          • Gayle M Gordillo, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Arm 1
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
125 mg to take BID for 14 weeks in Arm 1
Other Names:
  • PrimaVie
ACTIVE_COMPARATOR: Arm 2
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
250 mg to take BID for 14 weeks in Arm 2
Other Names:
  • PrimaVie
PLACEBO_COMPARATOR: Arm 3
15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks.
Drug: Placebo
Placebo supplement to take BID for 14 weeks in Arm 3
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
Time Frame: 14 weeks after oral supplementation
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
Time Frame: 14 weeks after oral supplementation
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
Time Frame: 14 weeks after oral supplementation
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
Time Frame: 14 weeks after oral supplementation
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
Time Frame: 14 weeks
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective visual assessment by photographs
Time Frame: 14 weeks
Identify subjectively by visual assessment, the effect of the PrimaVie supplement on skin appearance by the investigator/study physician at the end of 14 weeks of treatment from photographs taken at each time point.
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Collaborators

Natreon, Inc.

Investigators

  • Principal Investigator: Gayle M Gordillo, M.D., Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

March 21, 2016

First Submitted That Met QC Criteria

May 3, 2016

First Posted (ESTIMATE)

May 4, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 24, 2017

Last Update Submitted That Met QC Criteria

July 20, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DCS-71-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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