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Turmeric and Curcumin on Sebum Production

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by University of California, Davis
Sponsor:
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT03066791
First received: November 1, 2016
Last updated: July 10, 2017
Last verified: July 2017
  Purpose
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 Intervention
Inflammation; Skin Dietary Supplement: Turmeric tablets Dietary Supplement: Curcumin and Bioperine tablets Dietary Supplement: Placebo tablets

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Basic Science
Official Title: Pilot Study on the Effects of Oral Curcumin and Turmeric on Sebum Production

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 30
Actual Study Start Date: November 30, 2016
Estimated Study Completion Date: October 23, 2017
Estimated Primary Completion Date: October 23, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03066791

Contacts
Contact: Alexandra Trusler, B.S. 916-221-0441 atrusler@ucdavis.edu

Locations
United States, California
University of California, Davis Dermatology Clinical Trials Unit Recruiting
Sacramento, California, United States, 95816
Contact: Manisha Notay, MBBS    916-734-6550    mnotay@ucdavis.edu   
Principal Investigator: Raja Sivamani, MD MS CAT         
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Raja K Sivamani, M.D. University of California, Davis
  More Information

Publications:
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03066791     History of Changes
Other Study ID Numbers: 850932
Study First Received: November 1, 2016
Last Updated: July 10, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Inflammation
Dermatitis
Pathologic Processes
Skin Diseases
Curcumin
Turmeric extract
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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
Antioxidants
Protective Agents

ClinicalTrials.gov processed this record on July 24, 2017