Clinical trial NCT04597502: The Effects of Terminalia Chebula Fruit Extract on the Gut Microbiome and Skin Biophysical Properties
Official title: "The Effects of Synastol TC (Standardized Terminalia Chebula Fruit Extract) on the Gut Microbiome and Skin Biophysical Properties"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Microbiome
Keywords: gut microbiome
skin
dermatology
terminalia chebula
Lead sponsor: Integrative Skin Science and Research
Sponsor class: INDUSTRY
Collaborators: name: Sytheon Ltd.
First posted: 2020-10-22
Enrollment: 58
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Stool microbiome diversity
timeFrame: 8 weeks
measure: Sebum production
timeFrame: 8 weeks
Secondary outcomes:
measure: Transepidermal water loss
timeFrame: 8 weeks
measure: Facial pigmentation
timeFrame: 8 weeks
measure: Facial redness - Device Based
timeFrame: 8 weeks
measure: Facial wrinkles
timeFrame: 8 weeks
measure: Facial shine
timeFrame: 8 weeks
measure: hand and arm pigmentation
timeFrame: 8 weeks
measure: hand and arm redness
timeFrame: 8 weeks
measure: Tolerability of Topical Products
timeFrame: 8 weeks
measure: Skin typing questionnaire
timeFrame: 8 weeks
measure: Ayurvedic typing questionnaire
timeFrame: 8 weeks
measure: Salivary diurnal cortisol slope
timeFrame: 8 weeks
measure: Skin Hydration
timeFrame: 8 weeks
measure: Facial Redness - Image Based
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
Study officials:
affiliation: Integrative Skin Science and Research Institute
name: Raja K Sivamani, MD
role: PRINCIPAL_INVESTIGATOR
References: