Capsaicin Effect on Cytokines Profile in Dyslipidemia

NCT ID: NCT02823912

Last Updated: 2016-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2017-10-31

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

Conditions

Dyslipidemia; Overweight or Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Capsaicin

75 mg capsaicin every 12 hours for 90 days

Group Type: EXPERIMENTAL

Capsaicin

Intervention Type: DRUG

Control

75 mg magnesia calcinada every 12 hours for 90 days

Group Type: PLACEBO_COMPARATOR

Magnesia calcinada

Intervention Type: DRUG

Interventions

Capsaicin

Intervention Type: DRUG

Magnesia calcinada

Intervention Type: DRUG

Other Intervention Names

Capsicum

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PhD. Teresa Arcelia Garcia Cobian

UNKNOWN

Sponsor Role: collaborator

LN. Jessica Lucia Barajas Vega

UNKNOWN

Sponsor Role: collaborator

University of Guadalajara

OTHER

Sponsor Role: lead

Responsible Party

Ernesto Javier Ramirez Lizardo

PhD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ernesto J Ramirez Lizardo, PhD

Role: PRINCIPAL_INVESTIGATOR

University Guadalajara

Central Contacts

Leonel Garcia Benavides, PhD

Role: CONTACT

drleonelgb@hotmail.com

10585200

Other Identifiers

Capdis

Identifier Type: -

Identifier Source: org_study_id