Effect of Oral Calcium Butyrate Supplementation on Monocyte Mitochondrial Function and Gut Microbiota in Adults With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
The study will consist of a screening phase (pre-admission) and two visits, followed by asynchronous follow-up.
Pre-admission visit Participants meeting inclusion criteria (presence of obesity) will be recruited through advertisements published on official institutional platforms.
Informed consent will be explained and signed prior to any study-related procedures.
Participants will be informed about the study characteristics, procedures, risks, and expected benefits, including dietary intervention and biochemical assessments.
A clinical history will be obtained, including identification data, contact information, medical history, and current or recent use of medications and supplements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signing of the informed consent form.
- •Adults aged ≥18 years of age.
- •Body mass index (BMI) >30 kg/m².
排除标准
- •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.
研究者
Martha Guevara Cruz
Research
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran