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Turmeric and Curcumin on Sebum Production

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03066791
Recruitment Status : Completed
First Posted : February 28, 2017
Last Update Posted : December 19, 2018
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Inflammation; Skin Dietary Supplement: Turmeric tablets Dietary Supplement: Curcumin and Bioperine tablets Dietary Supplement: Placebo tablets Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Pilot Study on the Effects of Oral Curcumin and Turmeric on Sebum Production
Actual Study Start Date : November 30, 2016
Actual Primary Completion Date : August 28, 2017
Actual Study Completion Date : August 28, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Turmeric group

Turmeric Tablets:

Each tablet contains 1,000 mg of Turmeric (Curcuma Longa) per tablet. Dose: subjects will take 6 tablets per day, with a total daily dose of 6,000 mg.

Supplied by Sabinsa Corporation

Dietary Supplement: Turmeric tablets
Active Comparator: Curcumin Group

Curcumin and Bioperine tablets:

Each tablet contains 1,000mg Curcumin + 1.25mg black pepper. Dose: subjects will take 6 tablets per day, with a total dose of 6,000mg curcumin.

Supplied by Sabinsa corporation

Dietary Supplement: Curcumin and Bioperine tablets
Placebo Comparator: Placebo Group

Placebo tablets made to look like the turmeric and curcumin tablets

Each placebo tablet will contain: microcrystalline cellulose, dicalcium phosphate, PVPK30, sodium starch glycolate, magnesium stearate, OpaDry orange coating.

Dose: subjects in this group will take 6 placebo tablets per day

Dietary Supplement: Placebo tablets

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. Those who used topical medications in the past two weeks or systemic antibiotics or oral probiotics within one month of starting the study.
  3. Subjects who are postmenopausal
  4. Those who are pregnant or breastfeeding.
  5. Those that are prisoners or cognitively impaired.
  6. 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.
  7. Those that are taking angiotensin converting enzyme inhibitor medications or angiotensin receptor blocker medications for any reason.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03066791

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United States, California
University of California, Davis Dermatology Clinical Trials Unit
Sacramento, California, United States, 95816
Sponsors and Collaborators
University of California, Davis
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Principal Investigator: Raja K Sivamani, M.D. University of California, Davis
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Responsible Party: University of California, Davis Identifier: NCT03066791    
Other Study ID Numbers: 850932
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Pathologic Processes
Skin Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action