ObesityNCT06782009
Metabolic Impact on the Mitochondria-gut Microbiota Axis of Failure to Follow Restrictive Dietary Interventions in Subjects Living With Obesity
A study testing Calorie restriction, Intermittent fasting 16/8 and Ketogenic diet in people with Obesity, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 2 sites in Mexico.
Trial summary
Nutritional interventions with dietary restrictions have become highly popular for promoting weight and body fat loss; In addition, they are largely associated with the improvement and preservation of mitochondrial function as well as the changes they generate in the composition of the gut microbiota and microbial… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- Calorie restriction, Intermittent fasting 16/8 and Ketogenic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesMexico
- Study dates
- 8 Apr 2023to 8 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female.
- Adults >18 years of age.
- BMI ≥ 30 kg/m2
Who cannot join
- Patients with any type of diabetes.
- Patients with high blood pressure.
- Patients with acquired diseases secondarily producing obesity and diabetes.
- Patients who have suffered a cardiovascular event.
- Patients who at the screening visit presented glucose values greater than 126 mg/dL, triglycerides greater than 350 mg/dL, cholesterol greater than 300mg/dL and/or creatinine greater than 1.2 mg/dL in men and greater than 1 mg/dL in women.
- Patients with gastrointestinal diseases.
Show all 21Show fewer
- Weight loss > 3 kg in the last 3 months.
- Catabolic diseases such as cancer and acquired immunodeficiency syndrome.
- Pregnancy status.
- Positive smoking.
- History of major surgery requiring general or regional anesthesia, respiratory support, and involving a recovery time longer than 2 weeks, such as surgeries of the abdomen (bowel resection), chest, head, and neck.
- Diagnosis of Anxiety and Depression as Determined by the HADS Scale
- Drug treatment:
- Antihypertensive drugs or treatment
- Treatment with hypoglycemic agents 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.
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Tlalpan, 14080
Departamento de Fisiología de la Nutrición. Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, 14080
About this study
Nutritional interventions with dietary restrictions have become highly popular for promoting weight and body fat loss; In addition, they are largely associated with the improvement and preservation of mitochondrial function as well as the changes they generate in the composition of the gut microbiota and microbial metabolites. During obesity, mitochondrial dysfunction in monocytes can increase low-grade inflammation and contribute to alterations in various metabolic tissues. There have been many studies that have been dedicated to describing the benefits and mechanisms of the use of restrictive interventions, but few have focused on further monitoring and evaluating the metabolic changes that occur due to the lack of follow-up of the use of these interventions, where subjects resume eating patterns with energy overload. behavior that happens in the vast majority of patients, so keeping mitochondria in good condition is a key aspect of maintaining health. The present project aims to study the metabolic changes that are generated by the lack of follow-up of restrictive dietary interventions, focusing on the effects produced in mitochondrial function evaluated in monocytes isolated from peripheral blood and the impact that the composition of the intestinal microbiota is generated from the metabolites produced, affecting as a consequence the inflammatory state of the host. A randomized controlled clinical trial will be carried out where the selected participants will be assigned by lottery to one of the 3 nutritional interventions for 8 weeks, then the participants will be followed up at 8, 16 and 24 weeks after the intervention has ended. Anthropometric and biochemical parameters, resting energy expenditure, blood pressure, oxidative stress markers, metabolomics, gut microbiota composition, and mitochondrial function will be evaluated during follow-up.
Read the detailed description
The study consists of an open-label randomized controlled clinical trial. The selected subjects will be men or women over 18 years of age with a body mass index (BMI) greater than or equal to 30 kg/m2, who meet the selection criteria, the subjects who will be randomly assigned to one of 3 dietary intervention groups. The study consisted of a dietary intervention with a duration of 8 weeks and a follow-up of 24 weeks after dietary intervention.
The intervention groups will be as follows:
- Calorie-restricted diet: Dietary recommendations will be given restricting 30% in energy (kcal) according to their usual diet with normal macronutrient distribution (20-30% protein, 50-60% carbohydrates, 20-30% fats).
- Intermittent fasting diet: Dietary recommendations will be given according to the energy expenditure determined by indirect calorimetry with normal macronutrient distribution. Intermittent fasting will be used with a time-restricted model of 16:8. For 16 hours, they will not be able to eat or drink calories. In the other 8 hours, they need to adhere to the energy-restricted diet.
- Ketogenic diet: Recommendation will be given according to the energy expenditure determined by indirect calorimetry, with the following distribution of macronutrients: 20-25% protein, 5-10% carbohydrates, 70-80% fat.
Participants with calorie-restriction, intermittent fasting, or ketogenic diet dietary intervention will be provided with a food menu guide for fifteen days. After 8 weeks of the assigned intervention, patients will be provided with general dietary recommendations and will be invited to three more follow-up visits at 8, 16 and 24 weeks post-intervention. In addition, all participants will be provided with general recommendations for a physical activity plan for people living with obesity.
To evaluate adherence to treatment, participants will be asked to fill out 2 logbooks every two weeks (1 during the week and 1 for the weekend) in which they must record the type, amount and place where they consumed the food at each feeding time. They will also be called once a week for a 24-hour reminder. Participants on the ketogenic diet will be given test strips to measure ketones in urine.
- Conditions
- Obesity
- Being tested
- Calorie restriction, Intermittent fasting 16/8, Ketogenic diet
- Keywords
- dietary restrictions, intermittent fasting, mitochondrial function, gut microbiota, ketogenic diet
- Medical subject headings
- Obesity, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calorie restrictionOther
Participants will be provided with a food menu guide for fifteen days with a 30% energy restriction (kcal) according to their usual diet, with a macronutrient distribution of 20-30% protein, 50-60% carbohydrates and 20-30% fat.
Intermittent fasting 16/8Other
Participants will be provided with a food menu guide for fifteen days with an energy intake according to the energy expenditure determined by indirect calorimetry with normal distribution of macronutrients. Intermittent fasting will be used with a time-restricted model of 16:8. For 16 hours, they will not be able to eat or drink calories. In the other 8 hours, they need to adhere to the energy-restricted diet.
Ketogenic dietOther
Participants will be provided with a food menu guide for 15 days with an energy intake according to the energy expenditure determined by indirect calorimetry, with the following distribution of macronutrients: 20-25% protein, 5-10% carbohydrates, 70-80% fat.
| Study group | Role | What they receive |
|---|---|---|
| Calorie Restriction | Experimental | Participants will be provided with a food menu guide for fifteen days with a 30% energy restriction (kcal) according to their usual diet, with a macronutrient distribution of 20-30% protein, 50-60% carbohydrates and 20-30% fat. Receives: Other: Calorie restriction |
| Intermittent fasting 16/8 | Experimental | Participants will be provided with a food menu guide for fifteen days with an energy intake according to the energy expenditure determined by indirect calorimetry with normal distribution of macronutrients. Intermittent fasting will be used with a time-restricted model of 16:8. For 16 hours, they will not be able to eat or drink calories. In the other 8 hours, they need to adhere to the energy-restricted diet. Receives: Other: Intermittent fasting 16/8 |
| Ketogenic diet | Experimental | Participants will be provided with a food menu guide for 15 days with an energy intake according to the energy expenditure determined by indirect calorimetry, with the following distribution of macronutrients: 20-25% protein, 5-10% carbohydrates, 70-80% fat. Receives: Other: Ketogenic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mitochondrial function
Change in mitochondrial function determined by measuring the oxygen consumption rate (OCR) in isolated monocytes
Measured: baseline to 8, 16, 24 and 32 weeks
Secondary outcomes (20)
Gut microbiota composition
Change in gut microbiota composition determined by bacterial abundance obtained after taxonomy assignment.
Measured: baseline to 8, 16 and 32 weeks
Body weight measurement
Change in body weight determined by scale.
Measured: baseline to 8, 16, 24 and 32 weeks
Glucose concentration
Change in glucose in the serum determined by autoanalyzer.
Measured: baseline to 8, 16, 24 and 32 weeks
Cholesterol concentration
Change in cholesterol in the serum determined by autoanalyzer.
Measured: baseline to 8, 16, 24 and 32 weeks
HDL cholesterol concentration
Change in HDL cholesterol in the serum determined by autoanalyzer.
Measured: baseline to 8, 16, 24 and 32 weeks
LDL cholesterol concentration
Change in LDL cholesterol in the serum determined by autoanalyzer.
Measured: baseline to 8, 16, 24 and 32 weeks
Triglycerides concentration
Change in triglycerides in the serum determined by autoanalyzer.
Measured: baseline to 8, 16, 24 and 32 weeks
Insulin concentration
Change in insulin in the serum determined by ELISA kit.
Measured: baseline to 8, 16, 24 and 32 weeks
Leptin concentration
Change in leptin in the serum determined by ELISA kit.
Measured: baseline to 8, 16, 24 and 32 weeks
Interleukins concentration
Change in interleukins in the serum determined by ELISA kit.
Measured: baseline to 8, 16, 24 and 32 weeks
C-reactive protein concentration
Change in C-reactive protein in the serum determined by autoanalyzer.
Measured: baseline to 8, 16, 24 and 32 weeks
TNF-a concentration
Change in TNF-a in the serum determined by ELISA kit.
Measured: baseline to 8, 16, 24 and 32 weeks
Alpha diversity of gut microbiota
Shanon index to indicate alpha diversity of gut microbiota from the feces
Measured: baseline to 8, 16 and 32 weeks
Beta diversity of gut microbiota
Principal component analysis to indicate alpha diversity of gut microbiota from the feces
Measured: baseline to 8, 16 and 32 weeks
Fat mass percentage
Fat mass percentage determined by multifrequency electrical bioimpedance.
Measured: baseline to 8, 16, 24 and 32 weeks
Lean mass percentage
Lean mass percentage determined by multifrequency electrical bioimpedance.
Measured: baseline to 8, 16, 24 and 32 weeks
Skeletal muscle mass percentage
Skeletal muscle mass percentage determined by multifrequency electrical bioimpedance.
Measured: baseline to 8, 16, 24 and 32 weeks
Change of metabolites in serum
Change of metabolites in serum determined by un-targeted metabolomics using Liquid chromatography/ Mass spectrometry analysis (LC/MS).
Measured: baseline to 8, 16 and 32 weeks
Change of metabolites in feces
Change of metabolites in feces determined by un-targeted metabolomics using Liquid chromatography/ Mass spectrometry analysis (LC/MS).
Measured: baseline to 8, 16 and 32 weeks
Determination of valvular function
Doppler venous ultrasound will be performed with the MX7 equipment of the Shenzhen Mindray Bio-Medical Electronics Co., LTD to determine the valvular function of the great saphenous vein, small saphenous vein, junction femoral saphenous vein, femoral vein, popliteal vein, measuring their dimensions and the level of venous reflux.
Measured: baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start8 Apr 2023
- Primary completion8 Dec 2025
- Study completion8 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Model description
- The groups will receive the treatment simultaneously
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Alejandra Velázquez Villegas, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Laura A Velazquez Villegas, PhD, Principal investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782009
- Sponsor's protocol ID
- 4952
- Status last verified
- Mar 2026
- First submitted
- 8 Jan 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data may be shared after publication.
Publications
Guevara-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 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. Reply - Letter to the editor- enhancing understanding of dietary interventions in obesity: Insights and recommendations for future research. Clin Nutr. 2024 Sep;43(9):2211-2213. doi: 10.1016/j.clnu.2024.08.006. Epub 2024 Aug 13. No abstract available.
PubMed 39173436
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Impact on the Mitochondria-gut Microbiota Axis of Failure to Follow Restrictive Dietary Interventions in Subjects Living With Obesity
- ClinicalTrials.gov ID
- NCT06782009
- Acronym / sponsor ID
- 4952
- Conditions
- Obesity
- Keywords
- dietary restrictions, intermittent fasting, mitochondrial function, gut microbiota, ketogenic diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- 8 Apr 2023 (actual)
- Primary completion
- 8 Dec 2025 (actual)
- Study completion
- 8 Dec 2025 (actual)
- First posted
- 17 Jan 2025 (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.
Nutritional interventions with dietary restrictions have become highly popular for promoting weight and body fat loss; In addition, they are largely associated with the improvement and preservation of mitochondrial function as well as the changes they generate in the composition of the gut microbiota and microbial metabolites. During obesity, mitochondrial dysfunction in monocytes can increase low-grade inflammation and contribute to alterations in various metabolic tissues. There have been many studies that have been dedicated to describing the benefits and mechanisms of the use of restrictive interventions, but few have focused on further monitoring and evaluating the metabolic changes that occur due to the lack of follow-up of the use of these interventions, where subjects resume eating patterns with energy overload. behavior that happens in the vast majority of patients, so keeping mitochondria in good condition is a key aspect of maintaining health. The present project aims to study the metabolic changes that are generated by the lack of follow-up of restrictive dietary interventions, focusing on the effects produced in mitochondrial function evaluated in monocytes isolated from peripheral blood and the impact that the composition of the intestinal microbiota is generated from the metabolites produced, affecting as a consequence the inflammatory state of the host. A randomized controlled clinical trial will be carried out where the selected participants will be assigned by lottery to one of the 3 nutritional interventions for 8 weeks, then the participants will be followed up at 8, 16 and 24 weeks after the intervention has ended. Anthropometric and biochemical parameters, resting energy expenditure, blood pressure, oxidative stress markers, metabolomics, gut microbiota composition, and mitochondrial function will be evaluated during follow-up.
Detailed description
The study consists of an open-label randomized controlled clinical trial. The selected subjects will be men or women over 18 years of age with a body mass index (BMI) greater than or equal to 30 kg/m2, who meet the selection criteria, the subjects who will be randomly assigned to one of 3 dietary intervention groups. The study consisted of a dietary intervention with a duration of 8 weeks and a follow-up of 24 weeks after dietary intervention.
The intervention groups will be as follows:
- Calorie-restricted diet: Dietary recommendations will be given restricting 30% in energy (kcal) according to their usual diet with normal macronutrient distribution (20-30% protein, 50-60% carbohydrates, 20-30% fats).
- Intermittent fasting diet: Dietary recommendations will be given according to the energy expenditure determined by indirect calorimetry with normal macronutrient distribution. Intermittent fasting will be used with a time-restricted model of 16:8. For 16 hours, they will not be able to eat or drink calories. In the other 8 hours, they need to adhere to the energy-restricted diet.
- Ketogenic diet: Recommendation will be given according to the energy expenditure determined by indirect calorimetry, with the following distribution of macronutrients: 20-25% protein, 5-10% carbohydrates, 70-80% fat.
Participants with calorie-restriction, intermittent fasting, or ketogenic diet dietary intervention will be provided with a food menu guide for fifteen days. After 8 weeks of the assigned intervention, patients will be provided with general dietary recommendations and will be invited to three more follow-up visits at 8, 16 and 24 weeks post-intervention. In addition, all participants will be provided with general recommendations for a physical activity plan for people living with obesity.
To evaluate adherence to treatment, participants will be asked to fill out 2 logbooks every two weeks (1 during the week and 1 for the weekend) in which they must record the type, amount and place where they consumed the food at each feeding time. They will also be called once a week for a 24-hour reminder. Participants on the ketogenic diet will be given test strips to measure ketones in urine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- The groups will receive the treatment simultaneously
| Arm | Type | Receives |
|---|---|---|
| Calorie Restriction | Experimental | Other: Calorie restrictionParticipants will be provided with a food menu guide for fifteen days with a 30% energy restriction (kcal) according to their usual diet, with a macronutrient distribution of 20-30% protein, 50-60% carbohydrates and 20-30% fat. |
| Intermittent fasting 16/8 | Experimental | Other: Intermittent fasting 16/8Participants will be provided with a food menu guide for fifteen days with an energy intake according to the energy expenditure determined by indirect calorimetry with normal distribution of macronutrients. Intermittent fasting will be used with a time-restricted model of 16:8. For 16 hours, they will not be able to eat or drink calories. In the other 8 hours, they need to adhere to the energy-restricted diet. |
| Ketogenic diet | Experimental | Other: Ketogenic dietParticipants will be provided with a food menu guide for 15 days with an energy intake according to the energy expenditure determined by indirect calorimetry, with the following distribution of macronutrients: 20-25% protein, 5-10% carbohydrates, 70-80% fat. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female.
- Adults >18 years of age.
- BMI ≥ 30 kg/m2
Key exclusion criteria (21 listed)
- Patients with any type of diabetes.
- Patients with high blood pressure.
- Patients with acquired diseases secondarily producing obesity and diabetes.
- Patients who have suffered a cardiovascular event.
- Patients who at the screening visit presented glucose values greater than 126 mg/dL, triglycerides greater than 350 mg/dL, cholesterol greater than 300mg/dL and/or creatinine greater than 1.2 mg/dL in men and greater than 1 mg/dL in women.
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 |
|---|---|---|
| Calorie restrictionParticipants will be provided with a food menu guide for fifteen days with a 30% energy restriction (kcal) according to their usual diet, with a macronutrient distribution of 20-30% protein, 50-60% carbohydrates and 20-30% fat. | Other | Calorie Restriction |
| Intermittent fasting 16/8Participants will be provided with a food menu guide for fifteen days with an energy intake according to the energy expenditure determined by indirect calorimetry with normal distribution of macronutrients. Intermittent fasting will be used with a time-restricted model of 16:8. For 16 hours, they will not be able to eat or drink calories. In the other 8 hours, they need to adhere to the energy-restricted diet. | Other | Intermittent fasting 16/8 |
| Ketogenic dietParticipants will be provided with a food menu guide for 15 days with an energy intake according to the energy expenditure determined by indirect calorimetry, with the following distribution of macronutrients: 20-25% protein, 5-10% carbohydrates, 70-80% fat. | Other | Ketogenic diet |
Primary outcome
Mitochondrial function
Time frame: baseline to 8, 16, 24 and 32 weeks
Change in mitochondrial function determined by measuring the oxygen consumption rate (OCR) in isolated monocytes
20 secondary outcomes
Gut microbiota composition
Time frame: baseline to 8, 16 and 32 weeks
Body weight measurement
Time frame: baseline to 8, 16, 24 and 32 weeks
Glucose concentration
Time frame: baseline to 8, 16, 24 and 32 weeks
Cholesterol concentration
Time frame: baseline to 8, 16, 24 and 32 weeks
HDL cholesterol concentration
Time frame: baseline to 8, 16, 24 and 32 weeks
LDL cholesterol concentration
Time frame: baseline to 8, 16, 24 and 32 weeks
Triglycerides concentration
Time frame: baseline to 8, 16, 24 and 32 weeks
Insulin concentration
Time frame: baseline to 8, 16, 24 and 32 weeks
Leptin concentration
Time frame: baseline to 8, 16, 24 and 32 weeks
Interleukins concentration
Time frame: baseline to 8, 16, 24 and 32 weeks
C-reactive protein concentration
Time frame: baseline to 8, 16, 24 and 32 weeks
TNF-a concentration
Time frame: baseline to 8, 16, 24 and 32 weeks
Alpha diversity of gut microbiota
Time frame: baseline to 8, 16 and 32 weeks
Beta diversity of gut microbiota
Time frame: baseline to 8, 16 and 32 weeks
Fat mass percentage
Time frame: baseline to 8, 16, 24 and 32 weeks
Lean mass percentage
Time frame: baseline to 8, 16, 24 and 32 weeks
Skeletal muscle mass percentage
Time frame: baseline to 8, 16, 24 and 32 weeks
Change of metabolites in serum
Time frame: baseline to 8, 16 and 32 weeks
Change of metabolites in feces
Time frame: baseline to 8, 16 and 32 weeks
Determination of valvular function
Time frame: baseline to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- 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 39173436Guevara-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. Reply - Letter to the editor- enhancing understanding of dietary interventions in obesity: Insights and recommendations for future research. Clin Nutr. 2024 Sep;43(9):2211-2213. doi: 10.1016/j.clnu.2024.08.006. Epub 2024 Aug 13. No abstract available.
- Individual participant dataSharing planned: No. Data may be shared after publication.
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. This study is not recruiting at the moment.
Laura A Velazquez Villegas, PhD principal investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calorie restriction, Intermittent fasting 16/8 and Ketogenic diet in people with Obesity, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 2 sites 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 3 inclusion and 21 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: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mitochondrial function (time frame: baseline to 8, 16, 24 and 32 weeks). 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 NCT06782009, which also lists 2 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 27 Mar 2026.