Healthy Volunteers, Skin Barrier Dysfunction
Conditions
Brief summary
This pilot study will test how Fermented Papaya Preparation (FPP) impacts overall TEWL of areas that commonly display diminished barrier function, such as the skin from face, arms, and hands. Areas of diminished barrier function are defined as those not visible to the eye but identified as areas of high transepidermal water loss (TEWL) as measured by a non-invasive pen-like device. A TEWL value of 20 or higher at a location would be considered high TEWL. Participants will attend 5 visits over 20 weeks, with 12-weeks of FPP treatment, and 8-weeks of follow-up.
Interventions
DIETARY_SUPPLEMENTFermented Papaya Preparation (FPP)
Immun'Age Fermented Papaya Preparation
Sponsors
University of Pittsburgh
Osato Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. 50-75 years 2. Willing to allow collection of 3 blood samples (Baseline, Week 12 and Week 20) 3. Willing to log daily compliance with FPP intake during the study period (12 weeks) 4. Absence of active systemic disease per investigator judgement. 5. No current use of immunosuppressant or immunomodulatory medications. 6. No active dermatological conditions at measurement sites that could impair measure, per investigator judgement. 7. Investigator determination of general good health.
Exclusion criteria
1. Co-morbidity or concurrent medication that the Investigator deems impactful to patient safety or ability to adhere to FPP dosage. 2. Co-morbidity or concurrent medication that the Investigator deems confounding to outcome measure (i.e., topical or systemic steroid). 3. Current or history of allergy to FPP ingredients: Dextrose, Carica papaya, or Food yeast. 4. Concurrent participation in another interventional trial that may impact measures, per investigator judgement. 5. Uncontrolled diabetes (A1c \>7%). 6. Open wounds or actively receiving Wound Care services. 7. Pregnant or breastfeeding women. 8. Current use of warfarin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin surface temperature | From enrollment to the end of FPP at 12 weeks. | 9 anatomical sites. Unit Celsius |
| Transepidermal Water Loss (TEWL) | From enrollment to the end of FPP at 12 weeks. | 9 anatomical sites. Unit g/m²/h |
| Skin surface pH | From enrollment to the end of FPP at 12 weeks. | 9 anatomical sites. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Blood Count (CBC) | From enrollment to the end of FPP at 12 weeks. | Absolute Counts |
| Monocyte Inflammation Marker | From enrollment to the end of FPP at 12 weeks. | CD16 |
| Glucose Levels | From enrollment to the end of FPP at 12 weeks. | Unit mg/dL |
| HbA1c Levels | From enrollment to the end of FPP at 12 weeks. | Percentage |
Countries
United States
Contacts
CONTACTSavita Khanna, PhD
CONTACTScot King, DPT
PRINCIPAL_INVESTIGATORSavita Khanna, PhD
University of Pittsburgh
Outcome results
None listed