Effect of Oral Calcium Butyrate Supplementation in Obesity

ConditionObesity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

About this trial

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 criteria

Qualifiers

Signing of the informed consent form.

Adults aged ≥18 years of age.

Body mass index (BMI) >30 kg/m².

Both sex

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Placebo
  • Calcium butyrate

Treatment groups

42 Participants
are divided into 2 treatment groups