Capsaicin Effect on Cytokines Profile in Dyslipidemia

Dyslipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02823912
• Other study ID #: Capdis
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: July 1, 2016
• Last updated: July 15, 2016
• Start date: October 2016
• Est. completion date: October 2017

Study information

• Verified date: July 2016
• Source: University of Guadalajara
• Contact: Leonel Garcia Benavides, PhD
• Phone: 10585200
• Email: drleonelgb[@]hotmail.com
• Is FDA regulated: No
• Health authority: México: Secretaria de Salud
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 17
• Est. completion date: October 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 45 Years

Eligibility

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 8 History of hypersensitivity to the compounds used in the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Overweight
• Overweight or Obesity

Intervention

Drug:
• Capsaicin

• Magnesia calcinada

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Guadalajara	LN. Jessica Lucia Barajas Vega, PhD. Teresa Arcelia Garcia Cobian

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory cytokines profile	TNFa	90 days	No
Primary	Inflammatory cytokines profile	IL-1ß	90 days	No
Primary	Inflammatory cytokines profile	IL-6	90 days	No
Primary	Inflammatory cytokines profile	IL-8	90 days	No
Primary	Inflammatory cytokines profile	MIP-1ß	90 days	No
Secondary	Lipids profile	total cholesterol	90 days	No
Secondary	Lipids profile	triglycerides	90 days	No
Secondary	Lipids profile	C-HDL	90 days	No
Secondary	Lipids profile	C-LDL	90 days	No
Secondary	Lipids profile	C-VLDL	90 days	No