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
About this trial
This is an interventional treatment trial for Dyslipidemia focused on measuring Capsaicin, Dyslipidemia, Inflammatory cytokines
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
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
NCT ID
NCT02823912
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
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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