[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637713":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":44,"responsibleParty":57,"collaborators":25,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":25,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":85,"whyStopped":25,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","Participants will receive oral placebo capsules containing maltodextrin at a dose of 600 mg\u002Fday, administered as two 300 mg capsules once daily for 4 weeks. Furthermore, the participants will follow the same standardized isocaloric maintenance diet (50% carbohydrates, 20% protein, 30% fat) throughout the study.",[13],"Dietary Supplement: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Butyrate","EXPERIMENTAL","Participants will receive calcium butyrate capsules at a dose of 1000 mg\u002Fday (2 capsules of 500 mg) by oral administration once daily for 4 weeks. Furthermore, the participants will follow the same standardized isocaloric maintenance diet (50% carbohydrates, 20% protein, 30% fat) throughout the study.",[19],"Dietary Supplement: Calcium butyrate",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Oral placebo capsules containing maltodextrin, 300 mg per capsule. Participants assigned to the placebo comparator arm will take two capsules once daily, for a total dose of 600 mg\u002Fday, for 4 weeks.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Calcium butyrate","Oral calcium butyrate capsules, 500 mg per capsule. Participants assigned to the experimental arm will take two capsules once daily, for a total dose of 1000 mg\u002Fday, for 4 weeks.",[15],[31],{"name":32,"affiliation":5,"role":33},"Martha Guevara, PhD","STUDY_DIRECTOR",[35,41],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Martha Guevara, MD, PhD","CONTACT","+52 55 5487 0900","2802","martha.guevarac@incmnsz.mx",{"name":42,"role":37,"phone":38,"phoneExt":39,"email":43},"Lilia Noriega, PhD","lilia.noriegal@incmnsz.mx",[45],{"facility":46,"status":25,"city":47,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":25},"Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán","Mexico City","14080","Mexico","MX",{"type":52,"coordinates":53},"Point",[54,55],-99.12766,19.42847,{"lat":55,"lon":54},{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Martha Guevara Cruz","Research","100637713","effect-of-oral-calcium-butyrate-supplementation-in-obesity-100637713",false,"NCT07583017","Effect of Oral Calcium Butyrate Supplementation in Obesity","Effect of Oral Calcium Butyrate Supplementation on Monocyte Mitochondrial Function and Gut Microbiota in Adults With Obesity","Pacayeliztli","Inclusion Criteria:\n\n* Signing of the informed consent form.\n* Adults aged ≥18 years of age.\n* Body mass index (BMI) \\>30 kg\u002Fm².\n* Both sex\n\nExclusion Criteria:\n\n* Diabetes mellitus, defined as fasting glucose \\>126 mg\u002FdL during screening.\n* Hypertension, defined as blood pressure ≥130\u002F80 mmHg during screening.\n* Chronic kidney disease or estimated glomerular filtration rate \\\u003C60 mL\u002Fmin\u002F1.73 m².\n* Known liver disease.\n* Secondary causes of obesity or diabetes, including Cushing syndrome, clinical or subclinical hypothyroidism, or pheochromocytoma.\n* Catabolic diseases such as cancer or acquired immunodeficiency syndrome.\n\nDrug treatment:\n\n* Antihypertensive drugs or treatment (thiacycline, loop or potassium-sparing diuretics, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, alpha blockers, calcium antagonists, beta blockers).\n* Treatment with hypoglycemic agents (sulfonylureas, biguanides, incretins) or insulin and antidiabetic drugs.\n* Treatment with statins, fibrates or other drugs to control dyslipidemia.\n* Use of antibiotics in the three months prior to the study.\n* Use of steroid drugs, chemotherapy, immunosuppressants, or radiation therapy.\n* Anorexigenic or that accelerate weight loss such as sibutramine or orlistat.\n* Supplements with any of the functional foods used in the study.\n* Probiotic, prebiotic or symbiotic supplements.\n* Chronic proton pump inhibitor use or use within the last 2 weeks.\n* Chronic use of laxatives, antispasmodics, or medications affecting intestinal motility.\n* Current tobacco use.\n* Daily alcohol consumption \\>1 drink\u002Fday during the last month.\n* Use of recreational psychoactive substances.\n* Pregnancy or lactation.\n* Bariatric surgery or participation in intensive weight loss programs.\n* Weight loss ≥3 kg in less than 3 months.","ALL","18 Years",{"count":72,"type":73},42,"ESTIMATED","INTERVENTIONAL",[76],"NA","Obesity is characterized by gut microbiota dysbiosis, in which beneficial metabolites such as butyrate are reduced. Butyrate is a short-chain fatty acid produced by microbial fermentation that plays a key role in maintaining intestinal barrier integrity, regulating immune responses, and supporting mitochondrial function. Its depletion contributes to disruption of the intestinal barrier, facilitating the translocation of bacterial components and promoting systemic inflammation mediated by immune cell activation, like monocytes. This chronic inflammatory state is associated with mitochondrial dysfunction and impaired cellular bioenergetics. Butyrate has been investigated for its anti-inflammatory and metabolic effects, however, its direct impact on monocyte mitochondrial function and its relationship with gut microbiota composition in humans remains unclear.\n\nThis randomized, double-blind, placebo-controlled trial will evaluate the effect of oral calcium butyrate supplementation (1000 mg\u002Fday) compared with placebo for 4 weeks in adults with obesity. The primary objective is to determine the change in monocyte mitochondrial maximal respiration baseline to week 4.",[79],"Obesity",[79,15,81,82,83,84],"Gut microbiota","mitochondria","monocyte","short chain fatty acid","NOT_YET_RECRUITING","2026-05-07",{"date":88,"type":89},"2026-05-13","ACTUAL",{"date":91,"type":73},"2026-08-01",{"date":93,"type":73},"2028-12-30",{"name":5,"class":6},1]