ObesityPacayeliztliNCT07583017
Effect of Oral Calcium Butyrate Supplementation in Obesity
A study testing Calcium butyrate in people with Obesity, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Calcium butyrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteMexico
- Study dates
- 1 Aug 2026to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signing of the informed consent form.
- Adults aged ≥18 years of age.
- Body mass index (BMI) >30 kg/m².
- Both sex
Who cannot join
- 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.
Show all 23Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Mexico City, 14080
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Obesity
- Being tested
- Placebo, Calcium butyrate
- Keywords
- Obesity, Butyrate, Gut microbiota, mitochondria, monocyte, short chain fatty acid
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
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.
Calcium butyrateDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 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. Receives: Dietary Supplement: Placebo |
| Butyrate | Experimental | 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. Receives: Dietary Supplement: Calcium butyrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocyte mitochondrial maximal respiration in pmol O₂/min/10⁶
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.
Measured: From baseline to week 4 of the intervention
Gut microbiota composition as relative abundance percentage
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.
Measured: From baseline to week 4 of the intervention
Secondary outcomes (3)
Monocyte mitochondrial reserve respiratory capacity in pmol O₂/min/10⁶ cells
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.
Measured: From baseline to week 4 of the intervention
Monocyte Bioenergetic Health Index (BHI) score
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.
Measured: From baseline to week 4 of the intervention
Fecal butyrate concentration in µmol/g
Change in fecal butyrate concentration measured in stool samples by gas chromatography, and compared between the intervention and placebo groups.
Measured: From baseline to 4 week of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martha Guevara Cruz, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Martha Guevara, PhD, Study director, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583017
- Sponsor's protocol ID
- FNU-5904-26-27-1
- Acronym
- Pacayeliztli
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Borja-Magno AI, Furuzawa-Carballeda J, Guevara-Cruz M, Arias C, Granados J, Bourges H, Tovar AR, Sears B, Noriega LG, Gomez FE. Supplementation with EPA and DHA omega-3 fatty acids improves peripheral immune cell mitochondrial dysfunction and inflammation in subjects with obesity. J Nutr Biochem. 2023 Oct;120:109415. doi: 10.1016/j.jnutbio.2023.109415. Epub 2023 Jul 10.
PubMed 37437746Guevara-Cruz M, Hernandez-Gomez KG, Condado-Huerta C, Gonzalez-Salazar LE, Pena-Flores AK, Pichardo-Ontiveros E, Serralde-Zuniga AE, Sanchez-Tapia M, Maya O, Medina-Vera I, Noriega LG, Lopez-Barradas A, Rodriguez-Lima O, Mata I, Olin-Sandoval V, Torres N, Tovar AR, Velazquez-Villegas LA. Intermittent fasting, calorie restriction, and a ketogenic diet improve mitochondrial function by reducing lipopolysaccharide signaling in monocytes during obesity: A randomized clinical trial. Clin Nutr. 2024 Aug;43(8):1914-1928. doi: 10.1016/j.clnu.2024.06.036. Epub 2024 Jul 5.
PubMed 39003957Marino F, Petrella L, Cimmino F, Pizzella A, Monda A, Allocca S, Rotondo R, D'Angelo M, Musco N, Iommelli P, Catapano A, Bagnato C, Paolini B, Cavaliere G. From Obesity to Mitochondrial Dysfunction in Peripheral Tissues and in the Central Nervous System. Biomolecules. 2025 Apr 29;15(5):638. doi: 10.3390/biom15050638.
PubMed 40427531Guo Y, Shao M, Guan P, Yu M, Geng L, Gao Y, Meng L, Qu B. Co-Invasion of Congeneric Invasive Plants Adopts Different Strategies Depending on Their Origins. Plants (Basel). 2024 Jun 30;13(13):1807. doi: 10.3390/plants13131807.
PubMed 38999647Kalkan AE, BinMowyna MN, Raposo A, Ahmad MF, Ahmed F, Otayf AY, Carrascosa C, Saraiva A, Karav S. Beyond the Gut: Unveiling Butyrate's Global Health Impact Through Gut Health and Dysbiosis-Related Conditions: A Narrative Review. Nutrients. 2025 Apr 9;17(8):1305. doi: 10.3390/nu17081305.
PubMed 40284169Coppola S, Avagliano C, Calignano A, Berni Canani R. The Protective Role of Butyrate against Obesity and Obesity-Related Diseases. Molecules. 2021 Jan 28;26(3):682. doi: 10.3390/molecules26030682.
PubMed 33525625Cleophas MCP, Ratter JM, Bekkering S, Quintin J, Schraa K, Stroes ES, Netea MG, Joosten LAB. Effects of oral butyrate supplementation on inflammatory potential of circulating peripheral blood mononuclear cells in healthy and obese males. Sci Rep. 2019 Jan 28;9(1):775. doi: 10.1038/s41598-018-37246-7.
PubMed 30692581Coppola S, Nocerino R, Paparo L, Bedogni G, Calignano A, Di Scala C, de Giovanni di Santa Severina AF, De Filippis F, Ercolini D, Berni Canani R. Therapeutic Effects of Butyrate on Pediatric Obesity: A Randomized Clinical Trial. JAMA Netw Open. 2022 Dec 1;5(12):e2244912. doi: 10.1001/jamanetworkopen.2022.44912.
PubMed 36469320
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Calcium Butyrate Supplementation on Monocyte Mitochondrial Function and Gut Microbiota in Adults With Obesity
- ClinicalTrials.gov ID
- NCT07583017
- Acronym / sponsor ID
- Pacayeliztli / FNU-5904-26-27-1
- Conditions
- Obesity
- Keywords
- Obesity, Butyrate, Gut microbiota, mitochondria, monocyte, short chain fatty acid
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants 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. |
| Butyrate | Experimental | Dietary Supplement: Calcium butyrateParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signing of the informed consent form.
- Adults aged ≥18 years of age.
- Body mass index (BMI) >30 kg/m².
- Both sex
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboOral 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. | Dietary supplement | Placebo |
| Calcium butyrateOral 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. | Dietary supplement | Butyrate |
Primary outcome
Monocyte mitochondrial maximal respiration in pmol O₂/min/10⁶
Time frame: 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.
Gut microbiota composition as relative abundance percentage
Time frame: 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.
3 secondary outcomes
Monocyte mitochondrial reserve respiratory capacity in pmol O₂/min/10⁶ cells
Time frame: From baseline to week 4 of the intervention
Monocyte Bioenergetic Health Index (BHI) score
Time frame: From baseline to week 4 of the intervention
Fecal butyrate concentration in µmol/g
Time frame: From baseline to 4 week of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Background: PubMed 37437746Borja-Magno AI, Furuzawa-Carballeda J, Guevara-Cruz M, Arias C, Granados J, Bourges H, Tovar AR, Sears B, Noriega LG, Gomez FE. Supplementation with EPA and DHA omega-3 fatty acids improves peripheral immune cell mitochondrial dysfunction and inflammation in subjects with obesity. J Nutr Biochem. 2023 Oct;120:109415. doi: 10.1016/j.jnutbio.2023.109415. Epub 2023 Jul 10.
- Background: PubMed 39003957Guevara-Cruz M, Hernandez-Gomez KG, Condado-Huerta C, Gonzalez-Salazar LE, Pena-Flores AK, Pichardo-Ontiveros E, Serralde-Zuniga AE, Sanchez-Tapia M, Maya O, Medina-Vera I, Noriega LG, Lopez-Barradas A, Rodriguez-Lima O, Mata I, Olin-Sandoval V, Torres N, Tovar AR, Velazquez-Villegas LA. Intermittent fasting, calorie restriction, and a ketogenic diet improve mitochondrial function by reducing lipopolysaccharide signaling in monocytes during obesity: A randomized clinical trial. Clin Nutr. 2024 Aug;43(8):1914-1928. doi: 10.1016/j.clnu.2024.06.036. Epub 2024 Jul 5.
- Background: PubMed 40427531Marino F, Petrella L, Cimmino F, Pizzella A, Monda A, Allocca S, Rotondo R, D'Angelo M, Musco N, Iommelli P, Catapano A, Bagnato C, Paolini B, Cavaliere G. From Obesity to Mitochondrial Dysfunction in Peripheral Tissues and in the Central Nervous System. Biomolecules. 2025 Apr 29;15(5):638. doi: 10.3390/biom15050638.
- Background: PubMed 38999647Guo Y, Shao M, Guan P, Yu M, Geng L, Gao Y, Meng L, Qu B. Co-Invasion of Congeneric Invasive Plants Adopts Different Strategies Depending on Their Origins. Plants (Basel). 2024 Jun 30;13(13):1807. doi: 10.3390/plants13131807.
- Background: PubMed 40284169Kalkan AE, BinMowyna MN, Raposo A, Ahmad MF, Ahmed F, Otayf AY, Carrascosa C, Saraiva A, Karav S. Beyond the Gut: Unveiling Butyrate's Global Health Impact Through Gut Health and Dysbiosis-Related Conditions: A Narrative Review. Nutrients. 2025 Apr 9;17(8):1305. doi: 10.3390/nu17081305.
- Background: PubMed 33525625Coppola S, Avagliano C, Calignano A, Berni Canani R. The Protective Role of Butyrate against Obesity and Obesity-Related Diseases. Molecules. 2021 Jan 28;26(3):682. doi: 10.3390/molecules26030682.
- Background: PubMed 30692581Cleophas MCP, Ratter JM, Bekkering S, Quintin J, Schraa K, Stroes ES, Netea MG, Joosten LAB. Effects of oral butyrate supplementation on inflammatory potential of circulating peripheral blood mononuclear cells in healthy and obese males. Sci Rep. 2019 Jan 28;9(1):775. doi: 10.1038/s41598-018-37246-7.
- Background: PubMed 36469320Coppola S, Nocerino R, Paparo L, Bedogni G, Calignano A, Di Scala C, de Giovanni di Santa Severina AF, De Filippis F, Ercolini D, Berni Canani R. Therapeutic Effects of Butyrate on Pediatric Obesity: A Randomized Clinical Trial. JAMA Netw Open. 2022 Dec 1;5(12):e2244912. doi: 10.1001/jamanetworkopen.2022.44912.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martha Guevara, PhD study director
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium butyrate in people with Obesity, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martha Guevara, MD, PhD (+52 55 5487 0900 ext. 2802, martha.guevarac@incmnsz.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monocyte mitochondrial maximal respiration in pmol O₂/min/10⁶ (time frame: From baseline to week 4 of the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07583017, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.