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临床试验/NCT02823912
NCT02823912Unknown2 期

Effect of Administration of Capsaicin on Inflammatory Cytokines Profile(TNFα , IL - 1β , IL - 6, IL -8 , MIP - 1β) in Individuals With Dyslipidemia.

University of Guadalajara0 个研究点目标入组 17 人开始时间: 2016年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
17
主要终点
Inflammatory cytokines profile

研究概览

简要总结

The increased mortality from cardiovascular disease has a significant impact on the population, and the prevalence of these diseases it become one of the major problems, since it is the leading cause of mortality and 1 in 3 Mexicans suffer from cardiovascular disease according ENSANUT; the above is attributed to the increase of diseases associated with an inflammatory process accelerated as obesity, dyslipidemia, hypertension (SAH) and diabetes mellitus (DM).

The cholesterol is a major risk factor in the development of cardiovascular disease, and in turn increases the chances of death; however, the treatment of choice is based on changes in lifestyle, which for most people are difficult to maintain long-term. As for the drug therapy treated with drugs many people do not achieve their therapeutic goals, and therefore the inflammatory condition that underlies this disease remains.

Recent studies have focused on the possible role of capsaicin in the inflammatory state through the agonistic effect it has on TRPV1. It has demonstrated the antiinflammatory activity of capsaicin to enhance inflammation by free fatty acids (FFA) and reducing the expression of certain genes involved in this process induced. Capsaicin is a natural choice and well tolerated with few side effects limited to the gastrointestinal tract such as dyspepsia and intestinal irregularity, for the above is of interest to evaluate the effect of capsaicin on the profile of inflammatory cytokines in individuals with dyslipidemia.

详细描述

It will conduct a clinicala trial, double - blind, randomized and placebo control group. Female and male patients, with dyslipidemia. Two groups will be formed with 17 patients each (capsaicin 150 mg per day or Magnesia calcinada). At the beginning and end of the intervention clinical and laboratory determination. The data obteined were analyzed using SPSS statistical software version 22. It was considered statistically significant at p <0.05

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
25 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of dyslipidemia at the time of screening
  • BMI of 25 kg /m2 to 34.9 kg / m2
  • Without drug treatment in the last three months
  • Signature of consent information in writing

排除标准

  • Pregnant or lactating
  • Total cholesterol ≥ 239 mg / dL, ≥400 TG, LDL-C ≥139
  • Other inflammatory diseases
  • consumption of some type of supplement
  • Diagnosis or history of kidney or liver disease ∞ History of hypersensitivity to the compounds used in the study

研究组 & 干预措施

Capsaicin

Experimental

75 mg capsaicin every 12 hours for 90 days

干预措施: Capsaicin (Drug)

Control

Placebo Comparator

75 mg magnesia calcinada every 12 hours for 90 days

干预措施: Magnesia calcinada (Drug)

结局指标

主要结局

Inflammatory cytokines profile

时间窗: 90 days

MIP-1β

次要结局

  • Lipids profile(90 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ernesto Javier Ramirez Lizardo

PhD.

University of Guadalajara

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