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Effect of Oral Calcium Butyrate Supplementation in Obesity (Pacayeliztli)

7 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

42

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Komparator placebo: 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.
Suplement diety: 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.
Eksperymentalny: 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.
Suplement diety: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Monocyte mitochondrial maximal respiration in pmol O₂/min/10⁶
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Monocyte mitochondrial reserve respiratory capacity in pmol O₂/min/10⁶ cells
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Body mass index in kg/m²
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Śledczy

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

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 sierpnia 2026

Zakończenie podstawowe (Szacowany)

30 grudnia 2027

Ukończenie studiów (Szacowany)

30 grudnia 2028

Daty rejestracji na studia

Pierwszy przesłany

29 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

7 maja 2026

Pierwszy wysłany (Rzeczywisty)

13 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

7 maja 2026

Ostatnia weryfikacja

1 kwietnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • FNU-5904-26-27-1

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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