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临床试验/NCT03066791
NCT03066791已完成不适用

Pilot Study on the Effects of Oral Curcumin and Turmeric on Sebum Production

University of California, Davis2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年11月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Sebum production

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 to 50 years of age, and
  • Subject must be able to read and comprehend study procedures and consent forms.

排除标准

  • 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.

研究组 & 干预措施

Turmeric group

Active Comparator

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

干预措施: Turmeric tablets (Dietary Supplement)

Curcumin Group

Active Comparator

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

干预措施: Curcumin and Bioperine tablets (Dietary Supplement)

Placebo Group

Placebo Comparator

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

干预措施: Placebo tablets (Dietary Supplement)

结局指标

主要结局

Sebum production

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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