ObesityNCT05200468
Effect of Dietary Restrictions and Ketogenic Diet on Mitochondrial Function and Gut Microbiota in Subjects With Obesity
A study testing Ketogenic diet, Caloric restriction diet and Intermittent fasting 16/8 in people with Obesity, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial summary
The benefits of nutritional interventions with dietary restrictions are associated with improvement and preservation of mitochondrial function. Evidence suggests that dietary restrictions, including modifications in caloric intake (caloric restriction), or in the timing of food intake (e.g., intermittent fasting)… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- Ketogenic diet, Caloric restriction diet and Intermittent fasting 16/8
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteMexico
- Study dates
- 28 Jul 2022to 27 Mar 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female.
- Adults between 18 and 60 years of age.
- BMI ≥ 30 and ≤ 50 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 with gastrointestinal diseases.
- Weight loss > 3 kg in the last 3 months.
Show all 18Show fewer
- Catabolic diseases such as cancer and acquired immunodeficiency syndrome.
- Pregnancy status.
- Positive smoking.
- 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
1 site in 1 country.
Mexico1 site
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, 14080
About this study
Official title: Effect of Intermittent Fasting, Caloric Restriction and Ketogenic Diet on Mitochondrial Function and Gut Microbiota in Subjects With Obesity
The benefits of nutritional interventions with dietary restrictions are associated with improvement and preservation of mitochondrial function. Evidence suggests that dietary restrictions, including modifications in caloric intake (caloric restriction), or in the timing of food intake (e.g., intermittent fasting), play an important role in stimulating cell and mitochondrial autophagy, favoring the elimination of old and dysfunctional mitochondria. In addition to the observed effects on mitochondrial function, there is evidence that intermittent fasting, caloric restriction, and the ketogenic diet also generate changes in gut microbiota and microbial metabolite composition. The main aim of this study is to evaluate the effect of intermittent fasting, caloric restriction and ketogenic diet on mitochondrial function determined by respirometry in monocytes, modulated by the gut microbiota in subjects with obesity. An open randomized controlled clinical trial will be conducted with 80 participants divided by a draw in 4 nutritional interventions groups for 1 month, each for 20 participants, then participants will receive 550 mg of rifaximin and will finish the study with the assigned nutritional intervention for another month of follow-up. Knowledge of these dynamics will allow us to explore and understand the relationship between metabolites from the gut microbiota and their effect on mitochondrial function associated with the dietary interventions mentioned above.
Read the detailed description
The study consists of an open-label randomized controlled clinical trial. Selected subjects will be randomized to one of 4 dietary intervention groups for 1 month with energy intake according to the resting energy expenditure obtained by indirect calorimetry.
The intervention groups will be as follows; a) ketogenic diet, b) caloric restriction diet, c) intermittent fasting diet and, d) usual diet.
- Ketogenic diet: A dietary recommendation will be given which will be isocaloric according to the resting energy expenditure obtained by indirect calorimetry, containing the following macronutrient distribution: 25% protein, 10% carbohydrates, 65% fat.
- Caloric restriction diet: A dietary recommendation will be given according to their usual diet, 500 kcal will be restricted, containing the following macronutrient distribution: 25-35% protein, 45-55% carbohydrates, 20-30% fat.
- Intermittent fasting 16/8: Participants will have the same diet as the participants from the caloric restriction diet group, with the difference that intermittent fasting will be employed, with a time-restricted pattern of 16:8. During 16 hours; for example, from 04.00 pm to 08.00 am or from 05.00 pm to 09.00 am (fasting hours) participants will be fasted and no calories can be eaten or drunk. But participants in the fasting hours can drink water, unsweetened tea, unsweetened coffee and mineral water. In the other 8 hours, participants need to adhere to the energy restriction diet.
- Usual diet: Participants will not be recommended any diet, participants will be referred to follow their usual diet until the end of the study.
After one month of the assigned intervention, the antibiotic rifaximin will be prescribed to the participants in doses of 550mg, twice a day for 7 days. After the 7 days with the antibiotic, participants will complete another month with the dietary intervention according to the group that the participants were initially randomized.
Participants will be required to complete food logs (2 on weekdays and 1 for weekends) during each week in order to monitor adherence to the dietary plan. For this, a nutritionist will teach them how to complete the food log, where participants must record the type, quantity and place where the food was consumed at each feeding time. Also, 2 phone calls will be made each week to evaluate adherence to treatment. The adherence will be determined with the % of adherence to the dietary treatment as obtained in the analysis of the food logs. Similarly, urine ketone concentration will be determined to measure adherence to the ketogenic diet. A logbook will be provided by the investigator to the participants to record the consumption of the medication, which should be filled out daily by the participant.
- Conditions
- Obesity
- Being tested
- Ketogenic diet, Caloric restriction diet, Intermittent fasting 16/8
- Keywords
- dietary restrictions, ketogenic diet, mitochondrial function, gut microbiota
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic dietOther
Weekly menus will be delivered according to diet with the following macronutrient distribution: 25% protein, 10% carbohydrate, 65% fat. Participants will receive a 30-day food menu guide.
Caloric restriction dietOther
Weekly menus will be provided according to their usual diet with 500 kcal restriction with the following macronutrient distribution 25-35% protein, 45-55% carbohydrates, 20-30% fat. Participants will receive a 30-day food menu guide.
Intermittent fasting 16/8Other
Calorie-restricted menus will be provided with a 16:8 time-restricted feeding. The feeding window will be 8 hours with a fasting time of 16 hours (04.00 pm- 08.00 am or 05.00 pm - 09.00 am), during the fasting window participants will only be allowed to drink water, unsweetened tea, mineral water and coffee without added sugar. Participants will receive a 30-day food menu guide.
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic diet | Experimental | Weekly menus will be delivered according to diet with the following macronutrient distribution: 25% protein, 10% carbohydrate, 65% fat. Participants will receive a 30-day food menu guide. Receives: Other: Ketogenic diet |
| Caloric restriction diet | Experimental | Weekly menus will be provided according to their usual diet with 500 kcal restriction with the following macronutrient distribution 25-35% protein, 45-55% carbohydrates, 20-30% fat. Participants will receive a 30-day food menu guide. Receives: Other: Caloric restriction diet |
| Intermittent fasting 16/8 | Experimental | Calorie-restricted menus will be provided with a 16:8 time-restricted feeding. The feeding window will be 8 hours with a fasting time of 16 hours (04.00 pm- 08.00 am or 05.00 pm - 09.00 am), during the fasting window participants will only be allowed to drink water, unsweetened tea, mineral water and coffee without added sugar. Participants will receive a 30-day food menu guide. Receives: Other: Intermittent fasting 16/8 |
| habitual diet | No intervention | Participants will be advised to follow their usual diet until the end of the study. |
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 mitochondrial oxygen consumption rate in monocytes
Measured: Baseline to 4, 5 and 8 weeks
Secondary outcomes (14)
gut microbiota composition
Change in microbiota composition determined by alpha and beta diversity analysis to compare the baseline and final microbiota composition between different nutritional interventions in subjects with obesity.
Measured: Baseline to 4, 5 and 8 weeks
oxidative stress markers
Change in markers of oxidative stress determined by levels of malondialdehyde and reactive oxygen species to compare the baseline and final markers of oxidative stress between different nutritional interventions in subjects with obesity.
Measured: Baseline to 4, 5 and 8 weeks
body composition
Change in body composition determined by multifrequency electrical bioimpedance to compare the baseline and final fat mass, lean mass and skeletal muscle mass percentage between different nutritional interventions in subjects with obesity
Measured: Baseline to 4, 5 and 8 weeks
body weight
Change in body weight to compare the baseline and final body weight between different nutritional interventions in subjects with obesity
Measured: Baseline to 4, 5 and 8 weeks
grip strength
Change in grip strength determined by dynamometry to compare the baseline and final grip strength between different nutritional interventions in subjects with obesity.
Measured: Baseline to 4 and 8 weeks
glucose serum
Change in glucose in the serum determined by autoanalyzer to compare the baseline and final concentration of serum glucose between different nutritional interventions in subjects with obesity.
Measured: Baseline to 4 and 8 weeks
total cholesterol
Change in total cholesterol in the serum by autoanalyzer to compare the baseline and final concentration of serum total cholesterol between different nutritional interventions in subjects with obesity
Measured: Baseline to 4 and 8 weeks
HDL cholesterol
Change in HDL cholesterol serum by autoanalyzer to compare the baseline and final concentration of serum HDL-cholesterol between different nutritional interventions in subjects with obesity.
Measured: Baseline to 4 and 8 weeks
triglycerides
Change in triglycerides in the serum by autoanalyzer to compare the baseline and final concentration of serum triglycerides between different nutritional interventions in subjects with obesity.
Measured: Baseline to 4 and 8 weeks
LDL cholesterol
Change in LDL cholesterol in the serum by autoanalyzer to compare the baseline and final concentration of serum LDL cholesterol between different nutritional interventions in subjects with obesity.
Measured: Baseline to 4 and 8 weeks
leptin
Change in leptin concentration in the serum determined by ELISA kit to compare the baseline and final concentration of serum leptin between different nutritional interventions in subjects with obesity.
Measured: Baseline to 4 and 8 weeks
adiponectin
Change in adiponectin concentration in the serum determined by ELISA kit to compare the baseline and final concentration of serum leptin between different nutritional interventions in subjects with obesity.
Measured: Baseline to 4 and 8 weeks
C-reactive protein
Change in C-reactive protein concentration in the serum to compare the baseline and final concentration of serum C- reactive protein between different nutritional interventions in subjects with obesity.
Measured: Baseline to 4 and 8 weeks
blood pressure
Change in systolic and diastolic blood pressure to compare the baseline and final blood pressure between different nutritional interventions in subjects with obesity.
Measured: Baseline to 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start28 Jul 2022
- Primary completion30 Nov 2022
- Study completion27 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)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
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura A Velazquez Villegas, PhD, Principal investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200468
- Sponsor's protocol ID
- 3728
- Status last verified
- Mar 2023
- First submitted
- 7 Jan 2022
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roberts MN, Wallace MA, Tomilov AA, Zhou Z, Marcotte GR, Tran D, Perez G, Gutierrez-Casado E, Koike S, Knotts TA, Imai DM, Griffey SM, Kim K, Hagopian K, McMackin MZ, Haj FG, Baar K, Cortopassi GA, Ramsey JJ, Lopez-Dominguez JA. A Ketogenic Diet Extends Longevity and Healthspan in Adult Mice. Cell Metab. 2017 Sep 5;26(3):539-546.e5. doi: 10.1016/j.cmet.2017.08.005.
PubMed 28877457Rizza W, Veronese N, Fontana L. What are the roles of calorie restriction and diet quality in promoting healthy longevity? Ageing Res Rev. 2014 Jan;13:38-45. doi: 10.1016/j.arr.2013.11.002. Epub 2013 Nov 27.
PubMed 24291541Anson RM, Guo Z, de Cabo R, Iyun T, Rios M, Hagepanos A, Ingram DK, Lane MA, Mattson MP. Intermittent fasting dissociates beneficial effects of dietary restriction on glucose metabolism and neuronal resistance to injury from calorie intake. Proc Natl Acad Sci U S A. 2003 May 13;100(10):6216-20. doi: 10.1073/pnas.1035720100. Epub 2003 Apr 30.
PubMed 12724520Cignarella F, Cantoni C, Ghezzi L, Salter A, Dorsett Y, Chen L, Phillips D, Weinstock GM, Fontana L, Cross AH, Zhou Y, Piccio L. Intermittent Fasting Confers Protection in CNS Autoimmunity by Altering the Gut Microbiota. Cell Metab. 2018 Jun 5;27(6):1222-1235.e6. doi: 10.1016/j.cmet.2018.05.006.
PubMed 29874567Vidali S, Aminzadeh S, Lambert B, Rutherford T, Sperl W, Kofler B, Feichtinger RG. Mitochondria: The ketogenic diet--A metabolism-based therapy. Int J Biochem Cell Biol. 2015 Jun;63:55-9. doi: 10.1016/j.biocel.2015.01.022. Epub 2015 Feb 7.
PubMed 25666556Fabbiano S, Suarez-Zamorano N, Chevalier C, Lazarevic V, Kieser S, Rigo D, Leo S, Veyrat-Durebex C, Gaia N, Maresca M, Merkler D, Gomez de Aguero M, Macpherson A, Schrenzel J, Trajkovski M. Functional Gut Microbiota Remodeling Contributes to the Caloric Restriction-Induced Metabolic Improvements. Cell Metab. 2018 Dec 4;28(6):907-921.e7. doi: 10.1016/j.cmet.2018.08.005. Epub 2018 Aug 30.
PubMed 30174308Lanza IR, Zabielski P, Klaus KA, Morse DM, Heppelmann CJ, Bergen HR 3rd, Dasari S, Walrand S, Short KR, Johnson ML, Robinson MM, Schimke JM, Jakaitis DR, Asmann YW, Sun Z, Nair KS. Chronic caloric restriction preserves mitochondrial function in senescence without increasing mitochondrial biogenesis. Cell Metab. 2012 Dec 5;16(6):777-88. doi: 10.1016/j.cmet.2012.11.003.
PubMed 23217257Paoli A, Mancin L, Bianco A, Thomas E, Mota JF, Piccini F. Ketogenic Diet and Microbiota: Friends or Enemies? Genes (Basel). 2019 Jul 15;10(7):534. doi: 10.3390/genes10070534.
PubMed 31311141Hamanaka RB, Chandel NS. Mitochondrial reactive oxygen species regulate cellular signaling and dictate biological outcomes. Trends Biochem Sci. 2010 Sep;35(9):505-13. doi: 10.1016/j.tibs.2010.04.002. Epub 2010 Apr 27.
PubMed 20430626Ang QY, Alexander M, Newman JC, Tian Y, Cai J, Upadhyay V, Turnbaugh JA, Verdin E, Hall KD, Leibel RL, Ravussin E, Rosenbaum M, Patterson AD, Turnbaugh PJ. Ketogenic Diets Alter the Gut Microbiome Resulting in Decreased Intestinal Th17 Cells. Cell. 2020 Jun 11;181(6):1263-1275.e16. doi: 10.1016/j.cell.2020.04.027. Epub 2020 May 20.
PubMed 32437658Goodpaster BH, Sparks LM. Metabolic Flexibility in Health and Disease. Cell Metab. 2017 May 2;25(5):1027-1036. doi: 10.1016/j.cmet.2017.04.015.
PubMed 28467922Guevara-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 39003957
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intermittent Fasting, Caloric Restriction and Ketogenic Diet on Mitochondrial Function and Gut Microbiota in Subjects With Obesity
- ClinicalTrials.gov ID
- NCT05200468
- Acronym / sponsor ID
- 3728
- Conditions
- Obesity
- Keywords
- dietary restrictions, ketogenic diet, mitochondrial function, gut microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 27 Mar 2023 (actual)
- First posted
- 20 Jan 2022 (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.
The benefits of nutritional interventions with dietary restrictions are associated with improvement and preservation of mitochondrial function. Evidence suggests that dietary restrictions, including modifications in caloric intake (caloric restriction), or in the timing of food intake (e.g., intermittent fasting), play an important role in stimulating cell and mitochondrial autophagy, favoring the elimination of old and dysfunctional mitochondria. In addition to the observed effects on mitochondrial function, there is evidence that intermittent fasting, caloric restriction, and the ketogenic diet also generate changes in gut microbiota and microbial metabolite composition. The main aim of this study is to evaluate the effect of intermittent fasting, caloric restriction and ketogenic diet on mitochondrial function determined by respirometry in monocytes, modulated by the gut microbiota in subjects with obesity. An open randomized controlled clinical trial will be conducted with 80 participants divided by a draw in 4 nutritional interventions groups for 1 month, each for 20 participants, then participants will receive 550 mg of rifaximin and will finish the study with the assigned nutritional intervention for another month of follow-up. Knowledge of these dynamics will allow us to explore and understand the relationship between metabolites from the gut microbiota and their effect on mitochondrial function associated with the dietary interventions mentioned above.
Detailed description
The study consists of an open-label randomized controlled clinical trial. Selected subjects will be randomized to one of 4 dietary intervention groups for 1 month with energy intake according to the resting energy expenditure obtained by indirect calorimetry.
The intervention groups will be as follows; a) ketogenic diet, b) caloric restriction diet, c) intermittent fasting diet and, d) usual diet.
- Ketogenic diet: A dietary recommendation will be given which will be isocaloric according to the resting energy expenditure obtained by indirect calorimetry, containing the following macronutrient distribution: 25% protein, 10% carbohydrates, 65% fat.
- Caloric restriction diet: A dietary recommendation will be given according to their usual diet, 500 kcal will be restricted, containing the following macronutrient distribution: 25-35% protein, 45-55% carbohydrates, 20-30% fat.
- Intermittent fasting 16/8: Participants will have the same diet as the participants from the caloric restriction diet group, with the difference that intermittent fasting will be employed, with a time-restricted pattern of 16:8. During 16 hours; for example, from 04.00 pm to 08.00 am or from 05.00 pm to 09.00 am (fasting hours) participants will be fasted and no calories can be eaten or drunk. But participants in the fasting hours can drink water, unsweetened tea, unsweetened coffee and mineral water. In the other 8 hours, participants need to adhere to the energy restriction diet.
- Usual diet: Participants will not be recommended any diet, participants will be referred to follow their usual diet until the end of the study.
After one month of the assigned intervention, the antibiotic rifaximin will be prescribed to the participants in doses of 550mg, twice a day for 7 days. After the 7 days with the antibiotic, participants will complete another month with the dietary intervention according to the group that the participants were initially randomized.
Participants will be required to complete food logs (2 on weekdays and 1 for weekends) during each week in order to monitor adherence to the dietary plan. For this, a nutritionist will teach them how to complete the food log, where participants must record the type, quantity and place where the food was consumed at each feeding time. Also, 2 phone calls will be made each week to evaluate adherence to treatment. The adherence will be determined with the % of adherence to the dietary treatment as obtained in the analysis of the food logs. Similarly, urine ketone concentration will be determined to measure adherence to the ketogenic diet. A logbook will be provided by the investigator to the participants to record the consumption of the medication, which should be filled out daily by the participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- The groups will receive the treatment simultaneously
| Arm | Type | Receives |
|---|---|---|
| Ketogenic diet | Experimental | Other: Ketogenic dietWeekly menus will be delivered according to diet with the following macronutrient distribution: 25% protein, 10% carbohydrate, 65% fat. Participants will receive a 30-day food menu guide. |
| Caloric restriction diet | Experimental | Other: Caloric restriction dietWeekly menus will be provided according to their usual diet with 500 kcal restriction with the following macronutrient distribution 25-35% protein, 45-55% carbohydrates, 20-30% fat. Participants will receive a 30-day food menu guide. |
| Intermittent fasting 16/8 | Experimental | Other: Intermittent fasting 16/8Calorie-restricted menus will be provided with a 16:8 time-restricted feeding. The feeding window will be 8 hours with a fasting time of 16 hours (04.00 pm- 08.00 am or 05.00 pm - 09.00 am), during the fasting window participants will only be allowed to drink water, unsweetened tea, mineral water and coffee without added sugar. Participants will receive a 30-day food menu guide. |
| habitual diet | No intervention | –Participants will be advised to follow their usual diet until the end of the study. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male and female.
- Adults between 18 and 60 years of age.
- BMI ≥ 30 and ≤ 50 kg/m2.
Key exclusion criteria (18 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 with gastrointestinal diseases.
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 |
|---|---|---|
| Ketogenic dietWeekly menus will be delivered according to diet with the following macronutrient distribution: 25% protein, 10% carbohydrate, 65% fat. Participants will receive a 30-day food menu guide. | Other | Ketogenic diet |
| Caloric restriction dietWeekly menus will be provided according to their usual diet with 500 kcal restriction with the following macronutrient distribution 25-35% protein, 45-55% carbohydrates, 20-30% fat. Participants will receive a 30-day food menu guide. | Other | Caloric restriction diet |
| Intermittent fasting 16/8Calorie-restricted menus will be provided with a 16:8 time-restricted feeding. The feeding window will be 8 hours with a fasting time of 16 hours (04.00 pm- 08.00 am or 05.00 pm - 09.00 am), during the fasting window participants will only be allowed to drink water, unsweetened tea, mineral water and coffee without added sugar. Participants will receive a 30-day food menu guide. | Other | Intermittent fasting 16/8 |
Primary outcome
mitochondrial function
Time frame: Baseline to 4, 5 and 8 weeks
Change in mitochondrial function determined by mitochondrial oxygen consumption rate in monocytes
14 secondary outcomes
gut microbiota composition
Time frame: Baseline to 4, 5 and 8 weeks
oxidative stress markers
Time frame: Baseline to 4, 5 and 8 weeks
body composition
Time frame: Baseline to 4, 5 and 8 weeks
body weight
Time frame: Baseline to 4, 5 and 8 weeks
grip strength
Time frame: Baseline to 4 and 8 weeks
glucose serum
Time frame: Baseline to 4 and 8 weeks
total cholesterol
Time frame: Baseline to 4 and 8 weeks
HDL cholesterol
Time frame: Baseline to 4 and 8 weeks
triglycerides
Time frame: Baseline to 4 and 8 weeks
LDL cholesterol
Time frame: Baseline to 4 and 8 weeks
leptin
Time frame: Baseline to 4 and 8 weeks
adiponectin
Time frame: Baseline to 4 and 8 weeks
C-reactive protein
Time frame: Baseline to 4 and 8 weeks
blood pressure
Time frame: Baseline to 4 and 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 7 Dec 2023.
- Results publication: PubMed 28877457Roberts MN, Wallace MA, Tomilov AA, Zhou Z, Marcotte GR, Tran D, Perez G, Gutierrez-Casado E, Koike S, Knotts TA, Imai DM, Griffey SM, Kim K, Hagopian K, McMackin MZ, Haj FG, Baar K, Cortopassi GA, Ramsey JJ, Lopez-Dominguez JA. A Ketogenic Diet Extends Longevity and Healthspan in Adult Mice. Cell Metab. 2017 Sep 5;26(3):539-546.e5. doi: 10.1016/j.cmet.2017.08.005.
- Results publication: PubMed 24291541Rizza W, Veronese N, Fontana L. What are the roles of calorie restriction and diet quality in promoting healthy longevity? Ageing Res Rev. 2014 Jan;13:38-45. doi: 10.1016/j.arr.2013.11.002. Epub 2013 Nov 27.
- Results publication: PubMed 12724520Anson RM, Guo Z, de Cabo R, Iyun T, Rios M, Hagepanos A, Ingram DK, Lane MA, Mattson MP. Intermittent fasting dissociates beneficial effects of dietary restriction on glucose metabolism and neuronal resistance to injury from calorie intake. Proc Natl Acad Sci U S A. 2003 May 13;100(10):6216-20. doi: 10.1073/pnas.1035720100. Epub 2003 Apr 30.
- Results publication: PubMed 29874567Cignarella F, Cantoni C, Ghezzi L, Salter A, Dorsett Y, Chen L, Phillips D, Weinstock GM, Fontana L, Cross AH, Zhou Y, Piccio L. Intermittent Fasting Confers Protection in CNS Autoimmunity by Altering the Gut Microbiota. Cell Metab. 2018 Jun 5;27(6):1222-1235.e6. doi: 10.1016/j.cmet.2018.05.006.
- Results publication: PubMed 25666556Vidali S, Aminzadeh S, Lambert B, Rutherford T, Sperl W, Kofler B, Feichtinger RG. Mitochondria: The ketogenic diet--A metabolism-based therapy. Int J Biochem Cell Biol. 2015 Jun;63:55-9. doi: 10.1016/j.biocel.2015.01.022. Epub 2015 Feb 7.
- Results publication: PubMed 30174308Fabbiano S, Suarez-Zamorano N, Chevalier C, Lazarevic V, Kieser S, Rigo D, Leo S, Veyrat-Durebex C, Gaia N, Maresca M, Merkler D, Gomez de Aguero M, Macpherson A, Schrenzel J, Trajkovski M. Functional Gut Microbiota Remodeling Contributes to the Caloric Restriction-Induced Metabolic Improvements. Cell Metab. 2018 Dec 4;28(6):907-921.e7. doi: 10.1016/j.cmet.2018.08.005. Epub 2018 Aug 30.
- Results publication: PubMed 23217257Lanza IR, Zabielski P, Klaus KA, Morse DM, Heppelmann CJ, Bergen HR 3rd, Dasari S, Walrand S, Short KR, Johnson ML, Robinson MM, Schimke JM, Jakaitis DR, Asmann YW, Sun Z, Nair KS. Chronic caloric restriction preserves mitochondrial function in senescence without increasing mitochondrial biogenesis. Cell Metab. 2012 Dec 5;16(6):777-88. doi: 10.1016/j.cmet.2012.11.003.
- Results publication: PubMed 31311141Paoli A, Mancin L, Bianco A, Thomas E, Mota JF, Piccini F. Ketogenic Diet and Microbiota: Friends or Enemies? Genes (Basel). 2019 Jul 15;10(7):534. doi: 10.3390/genes10070534.
- Results publication: PubMed 20430626Hamanaka RB, Chandel NS. Mitochondrial reactive oxygen species regulate cellular signaling and dictate biological outcomes. Trends Biochem Sci. 2010 Sep;35(9):505-13. doi: 10.1016/j.tibs.2010.04.002. Epub 2010 Apr 27.
- Results publication: PubMed 32437658Ang QY, Alexander M, Newman JC, Tian Y, Cai J, Upadhyay V, Turnbaugh JA, Verdin E, Hall KD, Leibel RL, Ravussin E, Rosenbaum M, Patterson AD, Turnbaugh PJ. Ketogenic Diets Alter the Gut Microbiome Resulting in Decreased Intestinal Th17 Cells. Cell. 2020 Jun 11;181(6):1263-1275.e16. doi: 10.1016/j.cell.2020.04.027. Epub 2020 May 20.
- Results publication: PubMed 28467922Goodpaster BH, Sparks LM. Metabolic Flexibility in Health and Disease. Cell Metab. 2017 May 2;25(5):1027-1036. doi: 10.1016/j.cmet.2017.04.015.
- Derived from this study: 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.
- Individual participant dataSharing planned: No
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic diet, Caloric restriction diet and Intermittent fasting 16/8 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 3 inclusion and 18 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 7 Dec 2023. 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. 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 4, 5 and 8 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 NCT05200468, which also lists 12 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 7 Dec 2023.