Turmeric and Curcumin on Sebum Production

NCT ID: NCT03066791

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-08-28

Brief Summary

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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

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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.

Conditions

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Inflammation; Skin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Turmeric tablets

Intervention Type DIETARY_SUPPLEMENT

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

Group Type ACTIVE_COMPARATOR

Curcumin and Bioperine tablets

Intervention Type DIETARY_SUPPLEMENT

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

Group Type PLACEBO_COMPARATOR

Placebo tablets

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Turmeric tablets

Intervention Type DIETARY_SUPPLEMENT

Curcumin and Bioperine tablets

Intervention Type DIETARY_SUPPLEMENT

Placebo tablets

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raja K Sivamani, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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University of California, Davis Dermatology Clinical Trials Unit

Sacramento, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 17569219 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12676044 (View on PubMed)

Other Identifiers

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850932

Identifier Type: -

Identifier Source: org_study_id