Turmeric and Curcumin on Sebum Production

Pilot Study on the Effects of Oral Curcumin and Turmeric 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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Skin
• Intervention / Treatment: Dietary supplement: Turmeric tablets; Dietary supplement: Curcumin and Bioperine tablets; Dietary supplement: Placebo tablets

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • University of California, Davis Dermatology Clinical Trials Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sebum production	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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in Sebum profile, such as inflammatory markers at 8 weeks	8 weeks
Change in stool microbiome diversity (optional collections for subjects) from baseline at 8 weeks	8 weeks

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Raja K Sivamani, M.D., University of California, Davis

Publications and helpful links

General Publications

• Chainani-Wu N. Safety and anti-inflammatory activity of curcumin: a component of tumeric (Curcuma longa). J Altern Complement Med. 2003 Feb;9(1):161-8. doi: 10.1089/107555303321223035.
• Thangapazham RL, Sharma A, Maheshwari RK. Beneficial role of curcumin in skin diseases. Adv Exp Med Biol. 2007;595:343-57. doi: 10.1007/978-0-387-46401-5_15.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2016
• Primary Completion (Actual): August 28, 2017
• Study Completion (Actual): August 28, 2017

Study Registration Dates

• First Submitted: November 1, 2016
• First Submitted That Met QC Criteria: February 23, 2017
• First Posted (Actual): February 28, 2017

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 18, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Inflammation; Dermatitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: 850932

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No