NCT07583017Not yet recruiting
Effect of Oral Calcium Butyrate Supplementation in Obesity
Effect of Oral Calcium Butyrate Supplementation on Monocyte Mitochondrial Function and Gut Microbiota in Adults With Obesity
Source: ClinicalTrials.gov · Last updated 13 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 29 Apr 2026
- Start date
- 1 Aug 2026
- Primary completion date
- 30 Dec 2027
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Diseases
- Obesity
- NCT number
- NCT07583017
What you commit to
- Study type: Interventional
- Planned participants: 42
- From 1 Aug 2026 to the primary completion date, 30 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Chronic proton pump inhibitor use or use within the last 2 weeks.
- Chronic use of laxatives, antispasmodics, or medications affecting intestinal motility.
- Bariatric surgery or participation in intensive weight loss programs.
Other illness
- 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:
Lab values
- Diabetes mellitus, defined as fasting glucose \>126 mg/dL during screening.
- Antihypertensive drugs or treatment (thiacycline, loop or potassium-sparing diuretics, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, alpha blockers, calcium antagonists, beta blockers).
Other
- 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.
- Current tobacco use.
- Daily alcohol consumption \>1 drink/day during the last month.
- Use of recreational psychoactive substances.
- Pregnancy or lactation.
- Weight loss ≥3 kg in less than 3 months.
Who the study is looking for
- Signing of the informed consent form.
- Adults aged ≥18 years of age.
- Body mass index (BMI) \>30 kg/m².
- Both sex
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.