Capsaicin Effect on Cytokines Profile in Dyslipidemia
Effect of Administration of Capsaicin on Inflammatory Cytokines Profile(TNFα , IL - 1β , IL - 6, IL -8 , MIP - 1β) in Individuals With Dyslipidemia.
1 other identifier
interventional
17
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2016
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2016
CompletedFirst Posted
Study publicly available on registry
July 6, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedJuly 19, 2016
July 1, 2016
6 months
July 1, 2016
July 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Inflammatory cytokines profile
TNFα
90 days
Inflammatory cytokines profile
IL-1β
90 days
Inflammatory cytokines profile
IL-6
90 days
Inflammatory cytokines profile
IL-8
90 days
Inflammatory cytokines profile
MIP-1β
90 days
Secondary Outcomes (5)
Lipids profile
90 days
Lipids profile
90 days
Lipids profile
90 days
Lipids profile
90 days
Lipids profile
90 days
Study Arms (2)
Capsaicin
EXPERIMENTAL75 mg capsaicin every 12 hours for 90 days
Control
PLACEBO COMPARATOR75 mg magnesia calcinada every 12 hours for 90 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Guadalajaralead
- PhD. Teresa Arcelia Garcia Cobiancollaborator
- LN. Jessica Lucia Barajas Vegacollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ernesto J Ramirez Lizardo, PhD
University Guadalajara
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD.
Study Record Dates
First Submitted
July 1, 2016
First Posted
July 6, 2016
Study Start
October 1, 2016
Primary Completion
April 1, 2017
Study Completion
October 1, 2017
Last Updated
July 19, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share