HealthyPhase 1NCT02762032
Natreon Healthy Skin Study - PrimaVie Supplement
A Phase 1 study testing PrimaVie Herbal Supplement 125 and PrimaVie Herbal Supplement 250 in people with Healthy, run by Ohio State University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PrimaVie Herbal Supplement 125 and PrimaVie Herbal Supplement 250
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Feb 2016to 20 Dec 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- Currently taking the following medications:
- Steroids
- Beta-blockers
- Immunosuppressant's
- Hydochlorothiazide,
- Statins
- Aspirin
- ACE Inhibitors
- Muscle relaxants
- Stimulants
- Prisoners
- Males
Trial locations and contacts
3 sites in 1 country.
United States3 sites
OSU Hospital East
Columbus, Ohio, 43205
Davis Heart and Lung Research Institute
Columbus, Ohio, 43210
Martha Morehouse Medical Plaza 2050 Kenny Road
Columbus, Ohio, 43221
About this study
Official title: 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.
Read the 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
- Being tested
- PrimaVie Herbal Supplement 125, PrimaVie Herbal Supplement 250, Placebo
- Keywords
- Skin Biopsy, PrimaVie, Herbal Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrimaVie Herbal Supplement 125Dietary supplement
Also called PrimaVie
125 mg to take BID for 14 weeks in Arm 1
PrimaVie Herbal Supplement 250Dietary supplement
Also called PrimaVie
250 mg to take BID for 14 weeks in Arm 2
PlaceboDrug
Also called control supplement
Placebo supplement to take BID for 14 weeks in Arm 3
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | 15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks. Receives: 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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). An increase in PU means improved perfusion of the skin.
Measured: 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), which are arbitrary. An increase in uS means improved skin hydration and improved skin barrier function.
Measured: 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). An increase in mPA means worsening of skin elasticity.
Measured: 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 (TEWL) using the DermaLab Combo Series (g/m2/h). An increase in these units indicates a worsening of TEWL, and reduction of the barrier function of the skin.
Measured: 14 weeks after oral supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study start20 Feb 2016
- Primary completion1 Dec 2018
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Natreon, Inc.
- Responsible party
- Principal investigator, Gayle Gordillo, University of Pittsburgh
- Investigators
- Gayle M Gordillo, M.D., Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762032
- Sponsor's protocol ID
- DCS-71-14
- Status last verified
- Mar 2026
- First submitted
- 21 Mar 2016
- Last updated
- 25 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31161927
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ability of an Oral Supplement to Improve Skin Microperfusion, Hydration, Elasticity, and Barrier Function
- ClinicalTrials.gov ID
- NCT02762032
- Acronym / sponsor ID
- DCS-71-14
- Conditions
- Healthy
- Keywords
- Skin Biopsy, PrimaVie, Herbal Supplement
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Natreon, Inc.
- Study start
- 20 Feb 2016 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 4 May 2016 (estimated)
- Results
- Posted 25 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Dietary Supplement: PrimaVie Herbal Supplement 12515 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks. |
| Arm 2 | Active comparator | Dietary Supplement: PrimaVie Herbal Supplement 25015 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks. |
| Arm 3 | Placebo comparator | Drug: Placebo15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrimaVie Herbal Supplement 125Also: PrimaVie125 mg to take BID for 14 weeks in Arm 1 | Dietary supplement | Arm 1 |
| PrimaVie Herbal Supplement 250Also: PrimaVie250 mg to take BID for 14 weeks in Arm 2 | Dietary supplement | Arm 2 |
| PlaceboAlso: control supplementPlacebo supplement to take BID for 14 weeks in Arm 3 | Drug | Arm 3 |
Primary outcome
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). An increase in PU means improved perfusion of the skin.
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), which are arbitrary. An increase in uS means improved skin hydration and improved skin barrier function.
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). An increase in mPA means worsening of skin elasticity.
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 (TEWL) using the DermaLab Combo Series (g/m2/h). An increase in these units indicates a worsening of TEWL, and reduction of the barrier function of the skin.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31161927Das 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gayle M Gordillo, M.D. principal investigator
Indiana University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PrimaVie Herbal Supplement 125 and PrimaVie Herbal Supplement 250 in people with Healthy, run by Ohio State University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Non-invasive Skin Assessment of Skin Microperfusion (time frame: 14 weeks after oral supplementation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02762032, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.