Study Results
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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COMPLETED
NA
30 participants
INTERVENTIONAL
2016-11-30
2017-08-28
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
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
Turmeric tablets
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
Curcumin and Bioperine tablets
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
Placebo tablets
Interventions
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Turmeric tablets
Curcumin and Bioperine tablets
Placebo tablets
Eligibility Criteria
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Inclusion Criteria
2. Subject must be able to read and comprehend study procedures and consent forms.
Exclusion Criteria
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.
18 Years
50 Years
ALL
Yes
Sponsors
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University of California, Davis
OTHER
Responsible Party
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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
Countries
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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.
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.
Other Identifiers
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850932
Identifier Type: -
Identifier Source: org_study_id