The Effects of Terminalia Chebula Fruit Extract on the Gut Microbiome and Skin Biophysical Properties

• ClinicalTrials.gov Identifier: NCT04597502
• Recruitment Status: Recruiting
• First Posted: October 22, 2020
• Last Update Posted: October 22, 2020
• Sponsor: Integrative Skin Science and Research
• Collaborator: Sytheon Ltd.
• Information provided by (Responsible Party): Integrative Skin Science and Research

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Human Microbiome	Dietary Supplement: Terminalia Chebula fruit extract; Dietary Supplement: Placebo; Other: Topical Terminalia Chebula; Other: Topical Placebo	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: Double-blinded placebo controlled
• Primary Purpose: Treatment
• Official Title: "The Effects of Synastol TC (Standardized Terminalia Chebula Fruit Extract) on the Gut Microbiome and Skin Biophysical Properties"
• Estimated Study Start Date: October 15, 2020
• Estimated Primary Completion Date: July 1, 2021
• Estimated Study Completion Date: August 1, 2021

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Oral Placebo, Topical Placebo; Oral Placebo, Topical Placebo on both forearms and dorsal hands	Dietary Supplement: Placebo; Oral placebo taken by mouth twice per day; Other: Topical Placebo; Applied to both forearms and dorsal hands
Experimental: Oral Placebo, Topical TC; Oral Placebo, Topical TC on both forearms and dorsal hands	Dietary Supplement: Placebo; Oral placebo taken by mouth twice per day; Other: Topical Terminalia Chebula; Applied to both forearms and dorsal hands
Experimental: Oral TC, Topical Placebo; Oral TC, Topical Placebo on both forearms and dorsal hands	Dietary Supplement: Terminalia Chebula fruit extract; Oral TC fruit extract supplement taken by mouth twice per day; Other: Topical Placebo; Applied to both forearms and dorsal hands
Experimental: Oral TC, Topical TC; Oral TC, Topical TC on both forearms and dorsal hands	Dietary Supplement: Terminalia Chebula fruit extract; Oral TC fruit extract supplement taken by mouth twice per day; Other: Topical Terminalia Chebula; Applied to both forearms and dorsal hands

Outcome Measures

Primary Outcome Measures :

1. Stool microbiome diversity [ Time Frame: 8 weeks ]
   Stool is collected and analyzed for species of bacteria through nucleic acid sequencing.
2. Sebum production [ Time Frame: 8 weeks ]
   Delfin Sebumeter: 0-150 micrograms/cm^2

Secondary Outcome Measures :

1. Transepidermal water loss [ Time Frame: 8 weeks ]
   Delfin Vapometer 0-300g/m^2h
2. Facial pigmentation [ Time Frame: 8 weeks ]
   SkinColorCatchRGB range: 25-246 per channel
3. Facial redness - Device Based [ Time Frame: 8 weeks ]
   SkinColorCatch colorimeter RGB range: 25-246 per channel
4. Facial wrinkles [ Time Frame: 8 weeks ]
   BTBP Clarity Mini 3D camera: Wrinkle severity (depth and width measurement in unitless units)
5. Facial shine [ Time Frame: 8 weeks ]
   BTBP Clarity Mini 3D: (Surface reflection measured in unitless units)
6. hand and arm pigmentation [ Time Frame: 8 weeks ]
   SkinColorCatch colorimeter RGB range: 25-246 per channel
7. hand and arm redness [ Time Frame: 8 weeks ]
   SkinColorCatch colorimeter RGB range: 25-246 per channel
8. Tolerability of Topical Products [ Time Frame: 8 weeks ]
   Subjective Tolerability Questionnaire is collected
9. Skin typing questionnaire [ Time Frame: 8 weeks ]
   Subjective Questionnaire is collected
10. Ayurvedic typing questionnaire [ Time Frame: 8 weeks ]
    Subjective Questionnaire is collected
11. Salivary diurnal cortisol slope [ Time Frame: 8 weeks ]
    4 point salivary cortisol is measured over the course of a day
12. Skin Hydration [ Time Frame: 8 weeks ]
    Delfin MoisturemeterSC 0-150
13. Facial Redness - Image Based [ Time Frame: 8 weeks ]
    BTBP Clarity Mini 3D camera

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 55 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Raja Sivamani, MD; 9165241216; research@integrativeskinresearch.com

Locations

United States, California

Integrative Skin Science and Research; Recruiting

Sacramento, California, United States, 95815

Contact: Raja K Sivamani, MD 916-524-1216 raja.sivamani@integrativeskinresearch.com

Sponsors and Collaborators

Integrative Skin Science and Research

Sytheon Ltd.

Investigators

• Principal Investigator: Raja K Sivamani, MD; Integrative Skin Science and Research Institute

More Information

• Responsible Party: Integrative Skin Science and Research
• ClinicalTrials.gov Identifier: NCT04597502
• Other Study ID Numbers: TC-0203
• First Posted: October 22, 2020
• Last Update Posted: October 22, 2020
• Last Verified: October 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Integrative Skin Science and Research:

gut microbiome; skin; dermatology; terminalia chebula