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Completed

NCT Number: NCT04597502

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

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.

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Key information

Conditions

Age range

25 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Integrative Skin Science and Research

Sacramento, California, 95815, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Terminalia Chebula fruit extract

Dietary Supplement

Oral TC fruit extract supplement taken by mouth twice per day

Placebo

Dietary Supplement

Oral placebo taken by mouth twice per day

Topical Terminalia Chebula

Other

Applied to both forearms and dorsal hands

Topical Placebo

Other

Applied to both forearms and dorsal hands

Primary outcomes

  1. Stool microbiome diversity

    Time frame: 8 weeks

    Stool is collected and analyzed for species of bacteria through nucleic acid sequencing.

  2. Sebum production

    Time frame: 8 weeks

    Delfin Sebumeter: 0-150 micrograms/cm^2

Secondary outcomes

  1. Transepidermal water loss

    Time frame: 8 weeks

    Delfin Vapometer 0-300g/m^2h

  2. Facial pigmentation

    Time frame: 8 weeks

    SkinColorCatchRGB range: 25-246 per channel

  3. Facial redness - Device Based

    Time frame: 8 weeks

    SkinColorCatch colorimeter RGB range: 25-246 per channel

  4. Facial wrinkles

    Time frame: 8 weeks

    BTBP Clarity Mini 3D camera: Wrinkle severity (depth and width measurement in unitless units)

  5. Facial shine

    Time frame: 8 weeks

    BTBP Clarity Mini 3D: (Surface reflection measured in unitless units)

  6. hand and arm pigmentation

    Time frame: 8 weeks

    SkinColorCatch colorimeter RGB range: 25-246 per channel

  7. hand and arm redness

    Time frame: 8 weeks

    SkinColorCatch colorimeter RGB range: 25-246 per channel

  8. Tolerability of Topical Products

    Time frame: 8 weeks

    Subjective Tolerability Questionnaire is collected

  9. Skin typing questionnaire

    Time frame: 8 weeks

    Subjective Questionnaire is collected

  10. Ayurvedic typing questionnaire

    Time frame: 8 weeks

    Subjective Questionnaire is collected

  11. Salivary diurnal cortisol slope

    Time frame: 8 weeks

    4 point salivary cortisol is measured over the course of a day

  12. Skin Hydration

    Time frame: 8 weeks

    Delfin MoisturemeterSC 0-150

  13. Facial Redness - Image Based

    Time frame: 8 weeks

    BTBP Clarity Mini 3D camera

Sponsors and collaborators

Lead sponsor

Integrative Skin Science and Research

Industry

Collaborators

  • Sytheon Ltd.

Registry information

Official study title

"The Effects of Synastol TC (Standardized Terminalia Chebula Fruit Extract) on the Gut Microbiome and Skin Biophysical Properties"

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 22, 2020
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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