Natreon Healthy Skin Study - PrimaVie Supplement

The Ohio State University

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Dietary Supplement: PrimaVie Herbal Supplement 250; Dietary Supplement: PrimaVie Herbal Supplement 125; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02762032

DCS-71-14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups, including a placebo group

Arm 1

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: PrimaVie Herbal Supplement 125

Arm 2

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: PrimaVie Herbal Supplement 250

Arm 3

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo