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

"The Effects of Synastol TC (Standardized Terminalia Chebula Fruit Extract) on the Gut Microbiome and Skin Biophysical Properties"

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.

Study Overview

• Status: Completed
• Conditions: Human Microbiome
• Intervention / Treatment: Dietary supplement: Placebo; Other: Topical Placebo; Other: Topical Terminalia Chebula; Dietary supplement: Terminalia Chebula fruit extract

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95815
      • Integrative Skin Science and Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / 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	Other: Topical Placebo; Applied to both forearms and dorsal hands; Dietary supplement: Terminalia Chebula fruit extract; Oral TC fruit extract supplement taken by mouth twice per day
Experimental: Oral TC, Topical TC; Oral TC, Topical TC on both forearms and dorsal hands	Other: Topical Terminalia Chebula; Applied to both forearms and dorsal hands; Dietary supplement: Terminalia Chebula fruit extract; Oral TC fruit extract supplement taken by mouth twice per day

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Integrative Skin Science and Research
• Collaborators: Sytheon Ltd.
• Investigators: Principal Investigator: Raja K Sivamani, MD, Integrative Skin Science and Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Actual): March 29, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: October 9, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 13, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: skin; dermatology; gut microbiome; terminalia chebula
• Other Study ID Numbers: TC-0203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No