Psoriasis
Conditions
Brief summary
The goal of this clinical trial is to evaluate whether Viv, a consumer-grade dietary supplement derived from the Magnolia officinalis plant, has an effect on biomarkers of immune activity in adults with psoriasis. To address this question, this trial will compare Viv to a placebo (a look-alike substance that contains no drug). Participants will: * Take Viv or a placebo every day for 3 months. * Complete electronic questionnaires about their quality of life and psoriasis symptoms at the beginning of the study and again at 1 months and 3 months. * Be provided with at home blood collection kits, which they will use to collect blood at the beginning of the study and again at 1 months and 3 months. Researchers will analyze these blood samples to measure the levels of specific inflammatory proteins and evaluate how they change over the course of the study in the participants taking Viv compared to those taking placebo.
Interventions
DIETARY_SUPPLEMENTOral supplement containing 200mg Magnolia officinalis bark extract
Viv is a consumer grade oral supplement containing 200mg Magnolia officinalis bark extract encapsulated in a hypromellose capsule.
DIETARY_SUPPLEMENTPlacebo
Oral hypromellose capsule with all inactive ingredients but lacking the Magnolia officinalis bark extract
Sponsors
Sirt3 LLC
People Science, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male of female, aged 18 years or older at time of consent. * Diagnosis of stable psoriasis affecting for at least 6 months confirmed by a dermatologist. * Patients with psoriasis-associated comorbidities including psoriatic arthritis are permitted, as long as those comorbidities are not severe enough to require treatment with systemic therapies as defined in the
Exclusion criteria
. * Able to read and understand English. * Able to read, understand, and provide informed consent. * Able to use a personal smartphone device and download Chloe by People Science. * Able to receive shipment of the product at an address within the United States. * Able to adhere to study protocol (e.g., willing to collect and ship blood samples)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative change in plasma Beta defensin 2 from baseline | From baseline to the end of study product/placebo use at 12 weeks | Change in plasma Beta defensin 2 levels between placebo and study product group at 4 weeks and 12 weeks relative to baseline as measured by ELISA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exploratory analyses of serum proteomics | Baseline to end of study product/placebo use at 12 weeks | Change in plasma cytokine levels between placebo and study product groups at 4 weeks and 12 weeks relative to baseline as measured by high throughput plasma proteomics |
| Exploratory analysis of circulating immune cells | Baseline to end of study product/placebo use at 12 weeks | Change in proportions and activity of peripheral blood immune cells between placebo and study product groups at 12 weeks relative to baseline as measured by single cell sequencing |
| Quality of life assessment | Baseline to end of study product/placebo use at 12 weeks | Change in quality of life between placebo and study product group at 4, and 12 weeks relative to baseline as measured by self-reported Dermatology Life Quality Index (DLQI) |
| Self reported psoriasis symptoms | Baseline to end of study product/placebo use at 12 weeks | Change in self-reported psoriasis symptoms between placebo and study group at 12 weeks relative to baseline as measured by Psoriasis Symptom Scale (PSS) |
Countries
United States
Contacts
CONTACTAdeeb Rahman, PhD
Outcome results
None listed