Turmeric and Curcumin on Sebum Production

Not Applicable

Completed

• Conditions: Inflammation; Skin
• Interventions: Dietary Supplement: Placebo tablets; Dietary Supplement: Turmeric tablets; Dietary Supplement: Curcumin and Bioperine tablets

• Registration Number: NCT03066791
• Lead Sponsor: University of California, Davis

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-11-01
• Study Start: 2016-11-30
• Study First Submitted QC: 2017-02-23
• Study First Posted: 2017-02-28
• Primary Completion: 2017-08-28
• Study Completion: 2017-08-28
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-18
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo tablets	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
Turmeric group	Turmeric tablets	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 Group	Curcumin and Bioperine tablets	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

Primary Outcome Measures

Name	Time	Method
Sebum production	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

Name	Time	Method
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

Trial Locations

Locations (1)

University of California, Davis Dermatology Clinical Trials Unit; 🇺🇸 Sacramento, California, United States