Human Microbiome
Conditions
Keywords
gut microbiome, skin, dermatology, terminalia chebula
Brief summary
The purpose of this study is to assess the use of oral Terminalia chebula fruit extract on the gut microbiome and skin biophysical properties. The fruit is commonly used for skin treatments in India. It is thought to have antioxidant properties, reduce inflammation and affect the microorganisms in the gut. The information the investigators will learn from this study may indicate how and if oral dosing can affect the skin and gut microbiome. This may lead to an improved understanding of the skin and determine whether these oral products are effective for improving the skin's appearance.
Interventions
OTHERTopical Terminalia Chebula
Applied to both forearms and dorsal hands
OTHERTopical Placebo
Applied to both forearms and dorsal hands
DIETARY_SUPPLEMENTTerminalia Chebula fruit extract
Oral TC fruit extract supplement taken by mouth twice per day
DIETARY_SUPPLEMENTPlacebo
Oral placebo taken by mouth twice per day
Sponsors
Sytheon Ltd.
Integrative Skin Science and Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double-blinded placebo controlled
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Females aged 25 to 55 years of age 2. Subject must be able to read and comprehend study procedures and consent forms. 3. BMI 25-35
Exclusion criteria
1. Subjects must have no history of malignancy, kidney disease, or chronic steroid use. 2. No history of smoking or chewing tobacco or vaping nicotine based products within the past year or if the pack-year history of smoking tobacco is greater than 5 pack-years. 3. No history of anorexia 4. Those that are currently taking serotonin or SSRIs. 5. No intake of pomegranate containing drinks, walnuts, and strawberries two weeks prior to enrollment and throughout the study 6. Those who are unable to discontinue topical medications for two weeks. 7. Individuals who have had any medical or cosmetic procedure, such as laser resurfacing, or plastic surgery to the test site (face) within the last 6 months. This includes botulinum toxin, dermal fillers, collagen or other similar cosmetic procedure 8. Individuals who are currently using or during the past 30 days have used hydroquinone, or a retinoid such as Retin A, or other Rx/OTC Retinoid, or steroids. 9. Those who are unable to discontinue systemic antibiotics or oral probiotics for one month prior starting the study. 10. Those who are unable to discontinue their Triphala or Terminalia chebula regimen for one month prior to starting study. 11. Subjects who are postmenopausal or perimenopausal as determined by the investigator based on history or documented menopause 12. Males will be excluded to reduce the contribution from gender-based differences in testosterone which can affect sebum production on the face. 13. Those who are pregnant or breastfeeding 14. Those that are prisoners or cognitively impaired 15. Those who have a known allergy to Triphala or Terminalia chebula
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stool microbiome diversity | 8 weeks | Stool is collected and analyzed for species of bacteria through nucleic acid sequencing. |
| Sebum production | 8 weeks | Delfin Sebumeter: 0-150 micrograms/cm\^2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Facial pigmentation | 8 weeks | SkinColorCatchRGB range: 25-246 per channel |
| Facial redness - Device Based | 8 weeks | SkinColorCatch colorimeter RGB range: 25-246 per channel |
| Facial shine | 8 weeks | BTBP Clarity Mini 3D: (Surface reflection measured in unitless units) |
| hand and arm pigmentation | 8 weeks | SkinColorCatch colorimeter RGB range: 25-246 per channel |
| hand and arm redness | 8 weeks | SkinColorCatch colorimeter RGB range: 25-246 per channel |
| Facial wrinkles | 8 weeks | BTBP Clarity Mini 3D camera: Wrinkle severity (depth and width measurement in unitless units) |
| Skin typing questionnaire | 8 weeks | Subjective Questionnaire is collected |
| Ayurvedic typing questionnaire | 8 weeks | Subjective Questionnaire is collected |
| Salivary diurnal cortisol slope | 8 weeks | 4 point salivary cortisol is measured over the course of a day |
| Skin Hydration | 8 weeks | Delfin MoisturemeterSC 0-150 |
| Facial Redness - Image Based | 8 weeks | BTBP Clarity Mini 3D camera |
| Tolerability of Topical Products | 8 weeks | Subjective Tolerability Questionnaire is collected |
| Transepidermal water loss | 8 weeks | Delfin Vapometer 0-300g/m\^2h |
Countries
United States
Outcome results
None listed