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

Completed · Not applicable · Has a placebo group

Conditions studied: Human Microbiome

In brief

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.

Key facts

Study ID

NCT04597502

Run by

Integrative Skin Science and Research

People needed

58

Starts

2020-10-15

Expected to finish

2022-09-01

Last updated by the study team

2022-11-15

Who can join

Age: 25 and older, up to 55. Sex: female. Healthy volunteers: accepted.

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

Where it is running

• Integrative Skin Science and Research — Sacramento, California, United States

Full record on ClinicalTrials.gov

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