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Completed
NCT02762032
Natreon Healthy Skin Study - PrimaVie Supplement
Conditions: Healthy
Sex: Female
Ages: 30 Years – 65 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 45
Sponsor: Ohio State University
Location: OSU Hospital East Columbus Ohio
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.
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
Source: ClinicalTrials.gov (NCT02762032). StuddyBuddy aggregates publicly available trial information.