Tests calcium butyrate supplement in adults with obesity
Tests a calcium butyrate supplement against a placebo in adults with obesity.
Plain-language title generated from the registry record
Registry title: Effect of Oral Calcium Butyrate Supplementation in Obesity
Key facts
- Where
- Mexico City, MexicoSee the site
Where in Mexico
- Instituto Nacional de Ciencias Médicas y Nutrición Salvador ZubiránMexico City, MexicoNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Trial code
- NCT07583017
- Record updated
- 13 May 2026
- Original description
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.Read full original descriptionShow less
Effect of Oral Calcium Butyrate Supplementation on Monocyte Mitochondrial Function and Gut Microbiota in Adults With Obesity
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.
This randomized, double-blind, placebo-controlled trial will evaluate the effect of oral calcium butyrate supplementation (1000 mg/day) 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.
Inclusion: Signing of the informed consent form; Adults aged ≥18 years of age; Body mass index (BMI) >30 kg/m²; Both sex.
Exclusion: Treatment with hypoglycemic agents (sulfonylureas, biguanides, incretins) or insulin and antidiabetic drugs; Treatment with statins, fibrates or other drugs to control dyslipidemia; Use of antibiotics in the three months prior to the study; Use of steroid drugs, chemotherapy, immunosuppressants, or radiation therapy; Chronic proton pump inhibitor use or use within the last 2 weeks; Chronic use of laxatives, antispasmodics, or medications affecting intestinal motility; Bariatric surgery or participation in intensive weight loss programs; Hypertension, defined as blood pressure ≥130/80 mmHg during screening; Chronic kidney disease or estimated glomerular filtration rate <60 mL/min/1.73 m²; Known liver disease; Secondary causes of obesity or diabetes, including Cushing syndrome, clinical or subclinical hypothyroidism, or pheochromocytoma; Catabolic diseases such as cancer or acquired immunodeficiency syndrome; Drug treatment:; Diabetes mellitus, defined as fasting glucose >126 mg/dL during screening; Antihypertensive drugs or treatment (thiacycline, loop or potassium-sparing diuretics, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, alpha blockers, calcium antagonists, beta blockers); Anorexigenic or that accelerate weight loss such as sibutramine or orlistat; Supplements with any of the functional foods used in the study; Probiotic, prebiotic or symbiotic supplements; Current tobacco use; Daily alcohol consumption >1 drink/day during the last month; Use of recreational psychoactive substances; Pregnancy or lactation; Weight loss ≥3 kg in less than 3 months.