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

NCT ID: NCT04597502

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-15
• Study Completion Date: 2022-09-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Oral Placebo, Topical Placebo

Oral Placebo, Topical Placebo on both forearms and dorsal hands

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Oral placebo taken by mouth twice per day

Topical Placebo

Intervention Type: OTHER

Applied to both forearms and dorsal hands

Oral Placebo, Topical TC

Oral Placebo, Topical TC on both forearms and dorsal hands

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Oral placebo taken by mouth twice per day

Topical Terminalia Chebula

Intervention Type: OTHER

Applied to both forearms and dorsal hands

Oral TC, Topical Placebo

Oral TC, Topical Placebo on both forearms and dorsal hands

Group Type: EXPERIMENTAL

Terminalia Chebula fruit extract

Intervention Type: DIETARY_SUPPLEMENT

Oral TC fruit extract supplement taken by mouth twice per day

Topical Placebo

Intervention Type: OTHER

Applied to both forearms and dorsal hands

Oral TC, Topical TC

Oral TC, Topical TC on both forearms and dorsal hands

Group Type: EXPERIMENTAL

Terminalia Chebula fruit extract

Intervention Type: DIETARY_SUPPLEMENT

Oral TC fruit extract supplement taken by mouth twice per day

Topical Terminalia Chebula

Intervention Type: OTHER

Applied to both forearms and dorsal hands

Interventions

Terminalia Chebula fruit extract

Oral TC fruit extract supplement taken by mouth twice per day

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Oral placebo taken by mouth twice per day

Intervention Type: DIETARY_SUPPLEMENT

Topical Terminalia Chebula

Applied to both forearms and dorsal hands

Intervention Type: OTHER

Topical Placebo

Applied to both forearms and dorsal hands

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sytheon Ltd.

INDUSTRY

Sponsor Role: collaborator

Integrative Skin Science and Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raja K Sivamani, MD

Role: PRINCIPAL_INVESTIGATOR

Integrative Skin Science and Research Institute

Locations

Integrative Skin Science and Research

Sacramento, California, United States

Countries

United States

Other Identifiers

TC-0203

Identifier Type: -

Identifier Source: org_study_id