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Effect of Oral Calcium Butyrate Supplementation in Obesity (Pacayeliztli)

2026. május 7. frissítette: Martha Guevara Cruz, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Effect of Oral Calcium Butyrate Supplementation on Monocyte Mitochondrial Function and Gut Microbiota in Adults With Obesity

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.

A tanulmány áttekintése

Állapot

Még nincs toborzás

Körülmények

Beavatkozás / kezelés

Részletes leírás

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.

Anthropometric measurements (weight and height) will be obtained for BMI calculation.

Blood pressure will be measured after at least 5 minutes of rest, with two readings per arm separated by 3 minutes and averaged.

A blood sample will be collected to determine glucose, creatinine, and liver function tests.

Eligible participants will receive a stool collection kit with instructions for microbiota analysis and will be instructed to return the sample at the next visit.

Visit 1: Baseline Anthropometric measurements will be recorded (weight, height, waist circumference).

Body composition will be assessed using bioimpedance (fat mass, lean mass). Blood pressure will be measured following standardized procedures. A 24-hour dietary recall will be administered. The International Physical Activity Questionnaire will be applied. A blood sample will be collected to assess: Glucose, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides, insulin, liver enzymes, C-reactive protein, interleukin 6 and mitochondrial function.

The stool sample collected will be received for microbiota and short-chain fatty acids analysis.

Intervention Participants will be randomly assigned to either: Butyrate supplement group, or placebo group. An isocaloric maintenance diet will be prescribed (50% carbohydrates, 20% protein, 30% fat, 25 g/day fiber), including menus and food lists. Study capsules will be provided along with: Instructions for administration, adherence logbook, identification of adverse event monitoring (nausea, vomiting, abdominal discomfort, diarrhea, constipation, headache, dizziness, fatigue)

Visit 2: Final (After 4 weeks of intervention) Nutritional and Clinical Assessment Anthropometric measurements will be recorded (weight, height, waist circumference).

Body composition will be assessed using bioimpedance (fat mass, lean mass). Blood pressure will be measured following standardized procedures. A 24-hour dietary recall will be administered. The International Physical Activity Questionnaire will be applied. A blood sample will be collected to assess: Glucose, A blood sample will be collected to assess: Glucose, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides, insulin, liver enzymes, C-reactive protein, interleukin 6 and mitochondrial function and mitochondrial function.

The stool sample collected will be received for microbiota and short-chain fatty acids analysis.

Capsule count and adherence log review will be conducted. The adverse events questionnaire will be administered.

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

42

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányozza a kapcsolattartók biztonsági mentését

Tanulmányi helyek

  • Mexikó
    • Mexico City
      • Mexico City, Mexico City, Mexikó, 14080
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Felnőtt
  • Idősebb felnőtt

Egészséges önkénteseket fogad

Nem

Leírás

Inclusion Criteria:

  • Signing of the informed consent form.
  • Adults aged ≥18 years of age.
  • Body mass index (BMI) >30 kg/m².
  • Both sex

Exclusion Criteria:

  • 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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Kettős

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
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.
Étrend-kiegészítő: Placebo
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.
Kísérleti: 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.
Étrend-kiegészítő: Calcium butyrate
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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Monocyte mitochondrial maximal respiration in pmol O₂/min/10⁶
Időkeret: From baseline to week 4 of the intervention
Change in maximal respiration measured in Cluster of differentiation 14 (CD14+) monocytes using extracellular flux mitochondrial stress testing. Maximal respiration will be calculated as peak oxygen consumption rate (OCR) after Carbonyl cyanide-p-trifluoromethoxyphenylhydrazone (FCCP) stimulation minus non-mitochondrial respiration, and compared between the intervention and placebo groups.
From baseline to week 4 of the intervention
Gut microbiota composition as relative abundance percentage
Időkeret: From baseline to week 4 of the intervention
Changes in gut microbiota composition will be assessed by 16 svedberg unit (16S) ribonucleic acid ribosomal (rRNA) sequencing, including alpha diversity (Chao1, Shannon), beta diversity, and relative taxonomic. and compared between the intervention and placebo groups.
From baseline to week 4 of the intervention

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Monocyte mitochondrial reserve respiratory capacity in pmol O₂/min/10⁶ cells
Időkeret: From baseline to week 4 of the intervention
Change in reserve respiratory capacity measured in CD14+ monocytes using extracellular flux mitochondrial stress testing, will be calculated as the difference between maximal oxygen consumption rate and basal oxygen consumption rate, and compared between the intervention and placebo groups.
From baseline to week 4 of the intervention
Monocyte Bioenergetic Health Index (BHI) score
Időkeret: From baseline to week 4 of the intervention
Change in Bioenergetic Health Index measured in CD14+ monocytes using extracellular flux mitochondrial stress test. BHI will be calculated as (ATP-linked respiration × spare respiratory capacity) / (proton leak × non-mitochondrial respiration), and compared between the intervention and placebo groups.
From baseline to week 4 of the intervention
Fecal butyrate concentration in µmol/g
Időkeret: From baseline to 4 week of the intervention
Change in fecal butyrate concentration measured in stool samples by gas chromatography, and compared between the intervention and placebo groups.
From baseline to 4 week of the intervention

Egyéb eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Body mass index in kg/m²
Időkeret: From baseline to 4 week of the intervention
Change in body mass index calculated as weight in kilograms divided by height in meters squared, and compared between the intervention and placebo groups.
From baseline to 4 week of the intervention
Skeletal muscle mass percentage
Időkeret: From baseline to 4 week of the intervention
Change in skeletal muscle mass measured by bioimpedance, and compared between the intervention and placebo groups.
From baseline to 4 week of the intervention
Waist circumference in centimeter
Időkeret: From baseline to 4 week of the intervention
Change in waist circumference measured at the midpoint between the lower costal margin and the iliac crest at the end of a normal expiration, and compared between the intervention and placebo groups.
From baseline to 4 week of the intervention
Lean body mass percentage
Időkeret: From baseline to 4 week of the intervention
Change in lean body mass measured by bioimpedance, and compared between the intervention and placebo groups.
From baseline to 4 week of the intervention
Fat body mass percentage
Időkeret: From baseline to week 4 of the intervention
Change in fat mass percentage measured by bioimpedance, and compared between the intervention and placebo groups.
From baseline to week 4 of the intervention
Body weight in kilograms
Időkeret: From baseline to week 4 of the intervention
Change in body weight measured using a calibrated scale under fasting conditions and light clothing, and compared between the intervention and placebo groups.
From baseline to week 4 of the intervention
Systolic and diastolic blood pressure in mmHg
Időkeret: From baseline to 4 week of the intervention
Change in systolic and diastolic blood pressure with an appropriately sized cuff, and compared between the intervention and placebo groups.
From baseline to 4 week of the intervention
Serum glucose concentration in mg/dL
Időkeret: From baseline to week 4 of the intervention
Changes in the concentration of serum glucose measured by automated analyzer, and compared between the intervention and placebo groups.
From baseline to week 4 of the intervention
Total cholesterol serum concentration in mg/dL
Időkeret: From baseline to week 4 of the intervention
Changes in total cholesterol concentrations measured by automated analyzer, and compared between the intervention and placebo groups.
From baseline to week 4 of the intervention
High-density lipoprotein cholesterol serum concentration in mg/dL
Időkeret: From baseline to week 4 of the intervention
Changes in H igh-density lipoprotein cholesterol concentrations measured by automated analyzer, and compared between the intervention and placebo groups.
From baseline to week 4 of the intervention
Serum alanine aminotransferase concentration in IU/mL
Időkeret: From baseline to 4 week of the intervention
Changes in Serum alanine aminotransferase measured by automated analyzer, and compared between the intervention and placebo groups.
From baseline to 4 week of the intervention
Serum aspartate aminotransferase concentration in IU/mL
Időkeret: From baseline to week 4 of the intervention
Change in serum aspartate aminotransferase measured by automated analyzer, and compared between the intervention and placebo groups.
From baseline to week 4 of the intervention
Serum high-sensitivity C-reactive protein concentration in mg/dL
Időkeret: From baseline to 4 week of the intervention
Changes in high-sensitivity C-reactive protein determined by autoanalyzer, and compared between the intervention and placebo groups.
From baseline to 4 week of the intervention
Serum interleukin-6 (IL-6) concentration in pg/mL
Időkeret: From baseline to 4 week of the intervention
Changes in IL-6 concentrations measured by enzyme-linked immunosorbent assay, and compared between the intervention and placebo groups.
From baseline to 4 week of the intervention
Low-density lipoprotein cholesterol serum concentration in mg/dL
Időkeret: From baseline to week 4 of the intervention
Changes in High-density lipoprotein cholesterol concentrations measured by automated analyzer, and compared between the intervention and placebo groups.
From baseline to week 4 of the intervention

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Nyomozók

  • Tanulmányi igazgató: Martha Guevara, PhD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Általános kiadványok

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Becsült)

2026. augusztus 1.

Elsődleges befejezés (Becsült)

2027. december 30.

A tanulmány befejezése (Becsült)

2028. december 30.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. április 29.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. május 7.

Első közzététel (Tényleges)

2026. május 13.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. május 13.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. május 7.

Utolsó ellenőrzés

2026. április 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • FNU-5904-26-27-1

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

NEM

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

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