Effect of Oral Calcium Butyrate Supplementation in Obesity

Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study ID
NCT07583017
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DIETARY_SUPPLEMENT
    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 — DIETARY_SUPPLEMENT
    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 Details

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 Dates

First listed
May 13, 2026
Start date
Aug 1, 2026
Status verified
Apr 2026
Primary completion
Dec 30, 2027
Completion
Dec 30, 2028

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Participants will receive oral placebo capsules containing maltodextrin at a dose of 600 mg/day, administered as two 300 mg capsules once daily for 4 weeks. Furthermore, the participants will follow the same standardized isocaloric maintenance diet (50% carbohydrates, 20% protein, 30% fat) throughout the study.
  • Experimental: Butyrate
    Participants will receive calcium butyrate capsules at a dose of 1000 mg/day (2 capsules of 500 mg) by oral administration once daily for 4 weeks. Furthermore, the participants will follow the same standardized isocaloric maintenance diet (50% carbohydrates, 20% protein, 30% fat) throughout the study.

Primary Outcome Measure

Monocyte mitochondrial maximal respiration in pmol O₂/min/10⁶ [ Time Frame: From baseline to week 4 of the intervention ]

Central Contacts

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