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

NCT04597502 | Completed

• 1 other identifier: TC-0203
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Microbiome

Keywords

gut microbiome; skin; dermatology; terminalia chebula

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Transepidermal water loss

  8 weeks

• Facial pigmentation

  8 weeks

• Facial redness - Device Based

  8 weeks

• Facial wrinkles

  8 weeks

• Facial shine

  8 weeks

Study Arms (4)

Oral Placebo, Topical Placebo

PLACEBO COMPARATOR

Oral Placebo, Topical Placebo on both forearms and dorsal hands

Dietary Supplement: Placebo; Other: Topical Placebo

Oral Placebo, Topical TC

EXPERIMENTAL

Oral Placebo, Topical TC on both forearms and dorsal hands

Dietary Supplement: Placebo; Other: Topical Terminalia Chebula

Oral TC, Topical Placebo

EXPERIMENTAL

Oral TC, Topical Placebo on both forearms and dorsal hands

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

Oral TC, Topical TC

EXPERIMENTAL

Oral TC, Topical TC on both forearms and dorsal hands

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

Interventions

Terminalia Chebula fruit extract DIETARY_SUPPLEMENT

Oral TC fruit extract supplement taken by mouth twice per day

Oral TC, Topical Placebo; Oral TC, Topical TC

Placebo DIETARY_SUPPLEMENT

Oral placebo taken by mouth twice per day

Oral Placebo, Topical Placebo; Oral Placebo, Topical TC

Topical Terminalia Chebula OTHER

Applied to both forearms and dorsal hands

Oral Placebo, Topical TC; Oral TC, Topical TC

Topical Placebo OTHER

Applied to both forearms and dorsal hands

Oral Placebo, Topical Placebo; Oral TC, Topical Placebo

Eligibility Criteria

• Age: 25 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females aged 25 to 55 years of age
• Subject must be able to read and comprehend study procedures and consent forms.
• BMI 25-35

You may not qualify if:

• Subjects must have no history of malignancy, kidney disease, or chronic steroid use.
• 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.
• No history of anorexia
• Those that are currently taking serotonin or SSRIs.
• No intake of pomegranate containing drinks, walnuts, and strawberries two weeks prior to enrollment and throughout the study
• Those who are unable to discontinue topical medications for two weeks.
• 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
• 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.
• Those who are unable to discontinue systemic antibiotics or oral probiotics for one month prior starting the study.
• Those who are unable to discontinue their Triphala or Terminalia chebula regimen for one month prior to starting study.
• Subjects who are postmenopausal or perimenopausal as determined by the investigator based on history or documented menopause
• Males will be excluded to reduce the contribution from gender-based differences in testosterone which can affect sebum production on the face.
• Those who are pregnant or breastfeeding
• Those that are prisoners or cognitively impaired
• Those who have a known allergy to Triphala or Terminalia chebula

Sponsors & Collaborators

• Integrative Skin Science and Research: lead
• Sytheon Ltd.: collaborator

Study Sites (1)

Integrative Skin Science and Research

Sacramento, California, 95815, United States

Location

MeSH Terms

Interventions

chebulae fruit

Study Officials

• Raja K Sivamani, MD

  Integrative Skin Science and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blinded placebo controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 22, 2020
• Study Start: October 15, 2020
• Primary Completion: March 29, 2022
• Study Completion: September 1, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-11

Locations

US (1)