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

Human Microbiome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04597502
• Other study ID #: TC-0203
• Status: Completed
• Phase: N/A
• Start date: October 15, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: November 2022
• Source: Integrative Skin Science and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: September 1, 2022
• Est. primary completion date: March 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Human Microbiome

Intervention

Dietary Supplement:
• Terminalia Chebula fruit extract
Oral TC fruit extract supplement taken by mouth twice per day
• Placebo
Oral placebo taken by mouth twice per day

Other:
• Topical Terminalia Chebula
Applied to both forearms and dorsal hands
• Topical Placebo
Applied to both forearms and dorsal hands

Locations

Country	Name	City	State
United States	Integrative Skin Science and Research	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
Integrative Skin Science and Research	Sytheon Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool microbiome diversity	Stool is collected and analyzed for species of bacteria through nucleic acid sequencing.	8 weeks
Primary	Sebum production	Delfin Sebumeter: 0-150 micrograms/cm^2	8 weeks
Secondary	Transepidermal water loss	Delfin Vapometer 0-300g/m^2h	8 weeks
Secondary	Facial pigmentation	SkinColorCatchRGB range: 25-246 per channel	8 weeks
Secondary	Facial redness - Device Based	SkinColorCatch colorimeter RGB range: 25-246 per channel	8 weeks
Secondary	Facial wrinkles	BTBP Clarity Mini 3D camera: Wrinkle severity (depth and width measurement in unitless units)	8 weeks
Secondary	Facial shine	BTBP Clarity Mini 3D: (Surface reflection measured in unitless units)	8 weeks
Secondary	hand and arm pigmentation	SkinColorCatch colorimeter RGB range: 25-246 per channel	8 weeks
Secondary	hand and arm redness	SkinColorCatch colorimeter RGB range: 25-246 per channel	8 weeks
Secondary	Tolerability of Topical Products	Subjective Tolerability Questionnaire is collected	8 weeks
Secondary	Skin typing questionnaire	Subjective Questionnaire is collected	8 weeks
Secondary	Ayurvedic typing questionnaire	Subjective Questionnaire is collected	8 weeks
Secondary	Salivary diurnal cortisol slope	4 point salivary cortisol is measured over the course of a day	8 weeks
Secondary	Skin Hydration	Delfin MoisturemeterSC 0-150	8 weeks
Secondary	Facial Redness - Image Based	BTBP Clarity Mini 3D camera	8 weeks