Clinical Trial

Effect of Oral Calcium Butyrate Supplementation in Obesity

Study acronym: Pacayeliztli
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07583017
Lead Sponsor Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Conditions Obesity
Enrollment 42 participants
Start Date 2026-08-01
Primary Completion 2027-12-30 (estimated)
Study Completion 2028-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-13