Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Effect of Oral Calcium Butyrate Supplementation in Obesity (Pacayeliztli)

7. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

42

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: 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.
Kosttilskud: 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.
Eksperimentel: 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.
Kosttilskud: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Monocyte mitochondrial maximal respiration in pmol O₂/min/10⁶
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Monocyte mitochondrial reserve respiratory capacity in pmol O₂/min/10⁶ cells
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Body mass index in kg/m²
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

30. december 2027

Studieafslutning (Anslået)

30. december 2028

Datoer for studieregistrering

Først indsendt

29. april 2026

Først indsendt, der opfyldte QC-kriterier

7. maj 2026

Først opslået (Faktiske)

13. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FNU-5904-26-27-1

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Placebo

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Chile

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner