Turmeric and Curcumin on Sebum Production
|Inflammation; Skin||Dietary Supplement: Turmeric tablets Dietary Supplement: Curcumin and Bioperine tablets Dietary Supplement: Placebo tablets|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||Pilot Study on the Effects of Oral Curcumin and Turmeric on Sebum Production|
- 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.
- 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 ]
|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)|
Active Comparator: Turmeric group
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|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03066791
|Contact: Alexandra Trusler, B.S.||email@example.com|
|United States, California|
|University of California, Davis Dermatology Clinical Trials Unit||Recruiting|
|Sacramento, California, United States, 95816|
|Contact: Manisha Notay, MBBS 916-734-6550 firstname.lastname@example.org|
|Principal Investigator: Raja Sivamani, MD MS CAT|
|Principal Investigator:||Raja K Sivamani, M.D.||University of California, Davis|