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

Not Applicable

Completed

• Conditions: Human Microbiome
• Interventions: Dietary Supplement: Terminalia Chebula fruit extract; Dietary Supplement: Placebo; Other: Topical Terminalia Chebula; Other: Topical Placebo

• Registration Number: NCT04597502
• Lead Sponsor: Integrative Skin Science and Research

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-09
• Study Start: 2020-10-15
• Study First Submitted QC: 2020-10-15
• Study First Posted: 2020-10-22
• Primary Completion: 2022-03-29
• Study Completion: 2022-09-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-13
• Last Update Posted: 2022-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral TC, Topical Placebo	Terminalia Chebula fruit extract	Oral TC, Topical Placebo on both forearms and dorsal hands
Oral TC, Topical TC	Topical Terminalia Chebula	Oral TC, Topical TC on both forearms and dorsal hands
Oral Placebo, Topical Placebo	Topical Placebo	Oral Placebo, Topical Placebo on both forearms and dorsal hands
Oral Placebo, Topical TC	Placebo	Oral Placebo, Topical TC on both forearms and dorsal hands
Oral Placebo, Topical Placebo	Placebo	Oral Placebo, Topical Placebo on both forearms and dorsal hands
Oral TC, Topical TC	Terminalia Chebula fruit extract	Oral TC, Topical TC on both forearms and dorsal hands
Oral Placebo, Topical TC	Topical Terminalia Chebula	Oral Placebo, Topical TC on both forearms and dorsal hands
Oral TC, Topical Placebo	Topical Placebo	Oral TC, Topical Placebo on both forearms and dorsal hands

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Integrative Skin Science and Research; 🇺🇸 Sacramento, California, United States