Placebo: 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/day, for 4 weeks.
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/day, for 4 weeks.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Signing of the informed consent form.
* Adults aged ≥18 years of age.
* Body mass index (BMI) \>30 kg/m².
* Both sex
Exclusion Criteria:
* Diabetes mellitus, defined as fasting glucose \>126 mg/dL during screening.
* 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:
* Antihypertensive drugs or treatment (thiacycline, loop or potassium-sparing diuretics, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, alpha blockers, calcium antagonists, beta blockers).
* 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.
* 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.
* Chronic proton pump inhibitor use or use within the last 2 weeks.
* Chronic use of laxatives, antispasmodics, or medications affecting intestinal motility.
* Current tobacco use.
* Daily alcohol consumption \>1 drink/day during the last month.
* Use of recreational psychoactive substances.
* Pregnancy or lactation.
* Bariatric surgery or participation in intensive weight loss programs.
* Weight loss ≥3 kg in less than 3 months.
Primary outcome measure(s)
Monocyte mitochondrial maximal respiration in pmol O₂/min/10⁶ — From baseline to week 4 of the intervention Change in maximal respiration measured in Cluster of differentiation 14 (CD14+) monocytes using extracellular flux mitochondrial stress testing. Maximal respiration will be calculated as peak oxygen consumption rate (OCR) after Carbonyl cyanide-p-trifluoromethoxyphenylhydrazone (FCCP) stimulation minus non-mitochondrial respiration, and compared between the intervention and placebo groups.
Gut microbiota composition as relative abundance percentage — From baseline to week 4 of the intervention Changes in gut microbiota composition will be assessed by 16 svedberg unit (16S) ribonucleic acid ribosomal (rRNA) sequencing, including alpha diversity (Chao1, Shannon), beta diversity, and relative taxonomic. and compared between the intervention and placebo groups.
Trial sites (1)
Facility
City
Region
Status
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City
Mexico City
More Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran trials in Mexico
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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