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Capsaicin Effect on Cytokines Profile in Dyslipidemia

Primary Purpose

Dyslipidemia, Overweight or Obesity

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Capsaicin
Magnesia calcinada
Sponsored by
University of Guadalajara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia focused on measuring Capsaicin, Dyslipidemia, Inflammatory cytokines

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Capsaicin

    Control

    Arm Description

    75 mg capsaicin every 12 hours for 90 days

    75 mg magnesia calcinada every 12 hours for 90 days

    Outcomes

    Primary Outcome Measures

    Inflammatory cytokines profile
    TNFα
    Inflammatory cytokines profile
    IL-1β
    Inflammatory cytokines profile
    IL-6
    Inflammatory cytokines profile
    IL-8
    Inflammatory cytokines profile
    MIP-1β

    Secondary Outcome Measures

    Lipids profile
    total cholesterol
    Lipids profile
    triglycerides
    Lipids profile
    C-HDL
    Lipids profile
    C-LDL
    Lipids profile
    C-VLDL

    Full Information

    First Posted
    July 1, 2016
    Last Updated
    July 15, 2016
    Sponsor
    University of Guadalajara
    Collaborators
    PhD. Teresa Arcelia Garcia Cobian, LN. Jessica Lucia Barajas Vega
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02823912
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2016 (undefined)
    Primary Completion Date
    April 2017 (Anticipated)
    Study Completion Date
    October 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Guadalajara
    Collaborators
    PhD. Teresa Arcelia Garcia Cobian, LN. Jessica Lucia Barajas Vega

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dyslipidemia, Overweight or Obesity
    Keywords
    Capsaicin, Dyslipidemia, Inflammatory cytokines

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    17 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Capsaicin
    Arm Type
    Experimental
    Arm Description
    75 mg capsaicin every 12 hours for 90 days
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    75 mg magnesia calcinada every 12 hours for 90 days
    Intervention Type
    Drug
    Intervention Name(s)
    Capsaicin
    Other Intervention Name(s)
    Capsicum
    Intervention Type
    Drug
    Intervention Name(s)
    Magnesia calcinada
    Primary Outcome Measure Information:
    Title
    Inflammatory cytokines profile
    Description
    TNFα
    Time Frame
    90 days
    Title
    Inflammatory cytokines profile
    Description
    IL-1β
    Time Frame
    90 days
    Title
    Inflammatory cytokines profile
    Description
    IL-6
    Time Frame
    90 days
    Title
    Inflammatory cytokines profile
    Description
    IL-8
    Time Frame
    90 days
    Title
    Inflammatory cytokines profile
    Description
    MIP-1β
    Time Frame
    90 days
    Secondary Outcome Measure Information:
    Title
    Lipids profile
    Description
    total cholesterol
    Time Frame
    90 days
    Title
    Lipids profile
    Description
    triglycerides
    Time Frame
    90 days
    Title
    Lipids profile
    Description
    C-HDL
    Time Frame
    90 days
    Title
    Lipids profile
    Description
    C-LDL
    Time Frame
    90 days
    Title
    Lipids profile
    Description
    C-VLDL
    Time Frame
    90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Leonel Garcia Benavides, PhD
    Phone
    10585200
    Email
    drleonelgb@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ernesto J Ramirez Lizardo, PhD
    Organizational Affiliation
    University Guadalajara
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Capsaicin Effect on Cytokines Profile in Dyslipidemia

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