Ignite Creation Date:
2024-05-06 @ 8:46 AM
Last Modification Date:
2024-10-26 @ 12:05 PM
Study NCT ID:
NCT02823912
Status:
UNKNOWN
Last Update Posted:
2016-07-19
First Post:
2016-07-01
Brief Title:
Capsaicin Effect on Cytokines Profile in Dyslipidemia
Sponsor:
University of Guadalajara
Organization:
University of Guadalajara
Study Overview
Official Title:
Effect of Administration of Capsaicin on Inflammatory Cytokines ProfileTNFα IL - 1β IL - 6 IL -8 MIP - 1β in Individuals With Dyslipidemia
Status:
UNKNOWN
Status Verified Date:
2016-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None