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

Integrative Skin Science and Research

Status: Completed

Conditions: Human Microbiome

Treatments: Other: Topical Terminalia Chebula; Other: Topical Placebo; Dietary Supplement: Placebo; Dietary Supplement: Terminalia Chebula fruit extract

Study type: Interventional

Funder types: Industry

Identifiers

NCT04597502

TC-0203

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: Female

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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58 participants in 4 patient groups, including a placebo group

Oral Placebo, Topical Placebo

Placebo Comparator group

Description:

Oral Placebo, Topical Placebo on both forearms and dorsal hands

Treatment:

Other: Topical Placebo

Dietary Supplement: Placebo

Oral Placebo, Topical TC

Experimental group

Description:

Oral Placebo, Topical TC on both forearms and dorsal hands

Treatment:

Other: Topical Terminalia Chebula

Dietary Supplement: Placebo

Oral TC, Topical Placebo

Experimental group

Description:

Oral TC, Topical Placebo on both forearms and dorsal hands

Treatment:

Other: Topical Placebo

Dietary Supplement: Terminalia Chebula fruit extract

Oral TC, Topical TC

Experimental group

Description:

Oral TC, Topical TC on both forearms and dorsal hands

Treatment:

Dietary Supplement: Terminalia Chebula fruit extract

Other: Topical Terminalia Chebula