Capsaicin Effect on Cytokines Profile in Dyslipidemia

July 15, 2016 updated by: Ernesto Javier Ramirez Lizardo, University of Guadalajara

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

17

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Capsaicin
75 mg capsaicin every 12 hours for 90 days
Drug: Capsaicin
Other Names:
  • Capsicum
PLACEBO_COMPARATOR: Control
75 mg magnesia calcinada every 12 hours for 90 days
Drug: Magnesia calcinada

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory cytokines profile
Time Frame: 90 days
TNFα
90 days
Inflammatory cytokines profile
Time Frame: 90 days
IL-1β
90 days
Inflammatory cytokines profile
Time Frame: 90 days
IL-6
90 days
Inflammatory cytokines profile
Time Frame: 90 days
IL-8
90 days
Inflammatory cytokines profile
Time Frame: 90 days
MIP-1β
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipids profile
Time Frame: 90 days
total cholesterol
90 days
Lipids profile
Time Frame: 90 days
triglycerides
90 days
Lipids profile
Time Frame: 90 days
C-HDL
90 days
Lipids profile
Time Frame: 90 days
C-LDL
90 days
Lipids profile
Time Frame: 90 days
C-VLDL
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Guadalajara

Collaborators

PhD. Teresa Arcelia Garcia Cobian
LN. Jessica Lucia Barajas Vega

Investigators

  • Principal Investigator: Ernesto J Ramirez Lizardo, PhD, University Guadalajara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (ANTICIPATED)

April 1, 2017

Study Completion (ANTICIPATED)

October 1, 2017

Study Registration Dates

First Submitted

July 1, 2016

First Submitted That Met QC Criteria

July 5, 2016

First Posted (ESTIMATE)

July 6, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

July 19, 2016

Last Update Submitted That Met QC Criteria

July 15, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Capdis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dyslipidemia

Clinical Trials on Capsaicin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe