Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT03066791
Recruitment Status : Completed
First Posted : February 28, 2017
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date  ICMJE November 1, 2016
First Posted Date  ICMJE February 28, 2017
Last Update Posted Date December 19, 2018
Actual Study Start Date  ICMJE November 30, 2016
Actual Primary Completion Date August 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03066791 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2017)
  • Change from Baseline in Sebum profile, such as inflammatory markers at 8 weeks [ Time Frame: 8 weeks ]
  • Change in stool microbiome diversity (optional collections for subjects) from baseline at 8 weeks [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Turmeric and Curcumin on Sebum Production
Official Title  ICMJE Pilot Study on the Effects of Oral Curcumin and Turmeric on Sebum Production
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Inflammation; Skin
Intervention  ICMJE
  • Dietary Supplement: Turmeric tablets
  • Dietary Supplement: Curcumin and Bioperine tablets
  • Dietary Supplement: Placebo tablets
Study Arms  ICMJE
  • 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

    Intervention: 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

    Intervention: 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

    Intervention: Dietary Supplement: Placebo tablets
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 23, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 28, 2017
Actual Primary Completion Date August 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03066791
Other Study ID Numbers  ICMJE 850932
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Raja K Sivamani, M.D. University of California, Davis
PRS Account University of California, Davis
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP