Effect of Oral Calcium Butyrate Supplementation in Obesity

Starting soon · Not applicable · Has a placebo group

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT07583017

Run by

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

People needed

42

Starts

2026-08-01

Expected to finish

2028-12-30

Last updated by the study team

2026-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signing of the informed consent form.
• Adults aged ≥18 years of age.
• Body mass index (BMI) >30 kg/m².
• Both sex

You may not qualify if…

• 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.

Where it is running

• Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán — Mexico City, Mexico City, Mexico

Full record on ClinicalTrials.gov

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