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Completed

NCT Number: NCT03066791

Turmeric and Curcumin on Sebum Production

A noticeably increasing number of patients are asking for naturally based extracts and ingredients as supplementary dermatologic remedies. Patients are seeking natural and cost-effective skin care alternatives in place of prescription medications and procedures. Our study will evaluate the effects of oral curcumin and turmeric on sebum production in healthy subjects.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis Dermatology Clinical Trials Unit

Sacramento, California, 95816, United States

About this study

Turmeric extracts and curcumin have been shown to be safe, even at high doses without significant side-effects. Previous clinical studies in other inflammatory skin diseases have shown that a dosage of curcumin at 6,000 mg daily was effective while lower doses were not. In a human phase I clinical trial examining the effects of high dose curcumin in preventing premalignant lesions, even curcumin doses as high as 8,000 mg/day resulted in no toxic effects after 3 months. This study will involve participant ingestion of 6,000 mg/day of turmeric or curcumin to assess how this affects their sebum production.

The investigators will also be collecting stool from the study subjects, and examining how the curcumin and turmeric may modulate their gut microbiome. The investigators will specifically be looking to see if curcumin or turmeric have any changes on the gut flora towards bacteria that produce more short chain fatty acids. Certain bacteria that make up the microbiome produce short chain fatty acids, such as butyrate and propionate, which have demonstrated anti-inflammatory properties. Thus, it would be interesting to see if turmeric or curcumin exert any of its anti-inflammatory effects via modulation of the microbiome.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 18 to 50 years of age, and
  • Subject must be able to read and comprehend study procedures and consent forms.

Exclusion criteria

  • Subject should be generally healthy and have no smoking history in the past one year, and must have no history of diabetes, metabolic syndrome, known cardiovascular disease, malignancy, kidney disease, or chronic steroid use.
  • Those who used topical medications in the past two weeks or systemic antibiotics or oral probiotics within one month of starting the study.
  • Subjects who are postmenopausal
  • Those who are pregnant or breastfeeding.
  • Those that are prisoners or cognitively impaired.
  • Those who have a known allergy to black pepper should not participate in this clinical trial, since one of the treatments consists of tablets containing a small amount (1.25mg/tablet) of black pepper.
  • Those that are taking angiotensin converting enzyme inhibitor medications or angiotensin receptor blocker medications for any reason.

Treatment and study plan

Turmeric tablets

Dietary Supplement

Curcumin and Bioperine tablets

Dietary Supplement

Placebo tablets

Dietary Supplement

Primary outcomes

  1. Sebum production

    Time frame: 8 weeks

    Sebutapes will be used to measure sebum production at each visit. The sebutapes will then be collected and analyzed for fatty acids and lipid production.

Secondary outcomes

  1. Change from Baseline in Sebum profile, such as inflammatory markers at 8 weeks

    Time frame: 8 weeks

  2. Change in stool microbiome diversity (optional collections for subjects) from baseline at 8 weeks

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

Pilot Study on the Effects of Oral Curcumin and Turmeric on Sebum Production

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 28, 2017
Registry last updated
Dec 19, 2018

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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