Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-01-13 @ 10:47 PM
Study NCT ID:
NCT02823912
Status:
UNKNOWN
Last Update Posted:
2016-07-19
First Post:
2016-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Capsaicin Effect on Cytokines Profile in Dyslipidemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002211', 'term': 'Capsaicin'}], 'ancestors': [{'id': 'D053284', 'term': 'Polyunsaturated Alkamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005229', 'term': 'Fatty Acids, Monounsaturated'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 17}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-15', 'studyFirstSubmitDate': '2016-07-01', 'studyFirstSubmitQcDate': '2016-07-05', 'lastUpdatePostDateStruct': {'date': '2016-07-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inflammatory cytokines profile', 'timeFrame': '90 days', 'description': 'TNFα'}, {'measure': 'Inflammatory cytokines profile', 'timeFrame': '90 days', 'description': 'IL-1β'}, {'measure': 'Inflammatory cytokines profile', 'timeFrame': '90 days', 'description': 'IL-6'}, {'measure': 'Inflammatory cytokines profile', 'timeFrame': '90 days', 'description': 'IL-8'}, {'measure': 'Inflammatory cytokines profile', 'timeFrame': '90 days', 'description': 'MIP-1β'}], 'secondaryOutcomes': [{'measure': 'Lipids profile', 'timeFrame': '90 days', 'description': 'total cholesterol'}, {'measure': 'Lipids profile', 'timeFrame': '90 days', 'description': 'triglycerides'}, {'measure': 'Lipids profile', 'timeFrame': '90 days', 'description': 'C-HDL'}, {'measure': 'Lipids profile', 'timeFrame': '90 days', 'description': 'C-LDL'}, {'measure': 'Lipids profile', 'timeFrame': '90 days', 'description': 'C-VLDL'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Capsaicin', 'Dyslipidemia', 'Inflammatory cytokines'], 'conditions': ['Dyslipidemia', 'Overweight or Obesity']}, 'descriptionModule': {'briefSummary': '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).\n\nThe 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.\n\nRecent 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.', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of dyslipidemia at the time of screening\n* BMI of 25 kg /m2 to 34.9 kg / m2\n* Without drug treatment in the last three months\n* Signature of consent information in writing\n\nExclusion Criteria:\n\n* Pregnant or lactating\n* Total cholesterol ≥ 239 mg / dL, ≥400 TG, LDL-C ≥139\n* Other inflammatory diseases\n* consumption of some type of supplement\n* Diagnosis or history of kidney or liver disease ∞ History of hypersensitivity to the compounds used in the study'}, 'identificationModule': {'nctId': 'NCT02823912', 'briefTitle': 'Capsaicin Effect on Cytokines Profile in Dyslipidemia', 'organization': {'class': 'OTHER', 'fullName': 'University of Guadalajara'}, 'officialTitle': 'Effect of Administration of Capsaicin on Inflammatory Cytokines Profile(TNFα , IL - 1β , IL - 6, IL -8 , MIP - 1β) in Individuals With Dyslipidemia.', 'orgStudyIdInfo': {'id': 'Capdis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Capsaicin', 'description': '75 mg capsaicin every 12 hours for 90 days', 'interventionNames': ['Drug: Capsaicin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': '75 mg magnesia calcinada every 12 hours for 90 days', 'interventionNames': ['Drug: Magnesia calcinada']}], 'interventions': [{'name': 'Capsaicin', 'type': 'DRUG', 'otherNames': ['Capsicum'], 'armGroupLabels': ['Capsaicin']}, {'name': 'Magnesia calcinada', 'type': 'DRUG', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Leonel Garcia Benavides, PhD', 'role': 'CONTACT', 'email': 'drleonelgb@hotmail.com', 'phone': '10585200'}], 'overallOfficials': [{'name': 'Ernesto J Ramirez Lizardo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Guadalajara'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Guadalajara', 'class': 'OTHER'}, 'collaborators': [{'name': 'PhD. Teresa Arcelia Garcia Cobian', 'class': 'UNKNOWN'}, {'name': 'LN. Jessica Lucia Barajas Vega', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD.', 'investigatorFullName': 'Ernesto Javier Ramirez Lizardo', 'investigatorAffiliation': 'University of Guadalajara'}}}}