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Turmeric and Curcumin on Sebum Production

Primary Purpose

Inflammation; Skin

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Turmeric tablets
Curcumin and Bioperine tablets
Placebo tablets
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inflammation; Skin

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of California, Davis Dermatology Clinical Trials Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Turmeric group

Curcumin Group

Placebo Group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
November 1, 2016
Last Updated
December 18, 2018
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT03066791
Brief Title
Turmeric and Curcumin on Sebum Production
Official Title
Pilot Study on the Effects of Oral Curcumin and Turmeric on Sebum Production
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
November 30, 2016 (Actual)
Primary Completion Date
August 28, 2017 (Actual)
Study Completion Date
August 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation; Skin

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Turmeric group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Curcumin Group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
Turmeric tablets
Intervention Type
Dietary Supplement
Intervention Name(s)
Curcumin and Bioperine tablets
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo tablets
Primary Outcome Measure Information:
Title
Sebum production
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in Sebum profile, such as inflammatory markers at 8 weeks
Time Frame
8 weeks
Title
Change in stool microbiome diversity (optional collections for subjects) from baseline at 8 weeks
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raja K Sivamani, M.D.
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis Dermatology Clinical Trials Unit
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17569219
Citation
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.
Results Reference
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PubMed Identifier
12676044
Citation
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.
Results Reference
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Turmeric and Curcumin on Sebum Production

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