Clinical trial NCT02823912: Capsaicin Effect on Cytokines Profile in Dyslipidemia
Official title: Effect of Administration of Capsaicin on Inflammatory Cytokines Profile(TNFα , IL - 1β , IL - 6, IL -8 , MIP - 1β) in Individuals With Dyslipidemia.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Dyslipidemia
Overweight or Obesity
Keywords: Capsaicin
Dyslipidemia
Inflammatory cytokines
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
Collaborators: name: PhD. Teresa Arcelia Garcia Cobian
name: LN. Jessica Lucia Barajas Vega
First posted: 2016-07-06
Enrollment: 17
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Inflammatory cytokines profile
timeFrame: 90 days
measure: Inflammatory cytokines profile
timeFrame: 90 days
measure: Inflammatory cytokines profile
timeFrame: 90 days
measure: Inflammatory cytokines profile
timeFrame: 90 days
measure: Inflammatory cytokines profile
timeFrame: 90 days
Secondary outcomes:
measure: Lipids profile
timeFrame: 90 days
measure: Lipids profile
timeFrame: 90 days
measure: Lipids profile
timeFrame: 90 days
measure: Lipids profile
timeFrame: 90 days
measure: Lipids profile
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
affiliation: University Guadalajara
name: Ernesto J Ramirez Lizardo, PhD
role: PRINCIPAL_INVESTIGATOR
References: