Natreon Healthy Skin Study - PrimaVie Supplement

NCT ID: NCT02762032

Last Updated: 2017-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2019-12-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Arm 1

15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks.

Group Type: ACTIVE_COMPARATOR

PrimaVie Herbal Supplement 125

Intervention Type: DIETARY_SUPPLEMENT

125 mg to take BID for 14 weeks in Arm 1

Arm 2

15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks.

Group Type: ACTIVE_COMPARATOR

PrimaVie Herbal Supplement 250

Intervention Type: DIETARY_SUPPLEMENT

250 mg to take BID for 14 weeks in Arm 2

Arm 3

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo supplement to take BID for 14 weeks in Arm 3

Interventions

PrimaVie Herbal Supplement 125

125 mg to take BID for 14 weeks in Arm 1

Intervention Type: DIETARY_SUPPLEMENT

PrimaVie Herbal Supplement 250

250 mg to take BID for 14 weeks in Arm 2

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo supplement to take BID for 14 weeks in Arm 3

Intervention Type: DRUG

Other Intervention Names

PrimaVie; PrimaVie; control supplement

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Natreon, Inc.

INDUSTRY

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Gayle Gordillo

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gayle M Gordillo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

OSU Hospital East

Columbus, Ohio, United States

Site Status: RECRUITING

Davis Heart and Lung Research Institute

Columbus, Ohio, United States

Site Status: RECRUITING

Martha Morehouse Medical Plaza 2050 Kenny Road

Columbus, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Elizabeth A Murphy, BS

Role: CONTACT

elizabeth.murphy@osumc.edu

9377283980

Gayle M Gordillo, M.D.

Role: CONTACT

gayle.gordillo@osumc.edu

614-293-8566

Facility Contacts

Lauren Allison, RN

Role: primary

Lauren.Allison@osumc.edu

614-366-2783

Elizabeth Murphy, BS

Role: backup

elizabeth.murphy@osumc.edu

614-685-3173

Sashwati Roy, Ph.D

Role: primary

sashwati.roy@osumc.edu

614-247-7657

Amy H Hoover, LPN

Role: primary

Amy.Hoover@osumc.edu

614-293-0390

References

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.

Reference Type: DERIVED

PMID: 31161927 (View on PubMed)

Other Identifiers

DCS-71-14

Identifier Type: -

Identifier Source: org_study_id