Metabolic SyndromePSICRONUTNCT07389603
Effects of Restricted-time and Psychochrononutritional Feeding in People With Metabolic Syndrome
A study testing Time restricted eating and Psychochrononutritional intervention in people with Metabolic Syndrome, run by University of Guadalajara at 1 site in Mexico.
Trial summary
Metabolic syndrome is a cluster of risk factors, including abdominal obesity, high blood pressure, high triglycerides, and insulin resistance, that increase the risk of developing type 2 diabetes and cardiovascular disease. The prevalence of this syndrome is rising in Mexico. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Time restricted eating and Psychochrononutritional intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteMexico
- Study dates
- 4 Dec 2025to Jun 2026
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 60 years
- Both sexes
- Feeding window ≥14 h/day
- Usual sleep duration >6.5 h
- Individuals diagnosed with metabolic syndrome who meet three or more of the criteria from Panel III of the National Cholesterol Education Program's Adult Treatment Guidelines:
- Waist circumference: ≥102 cm for men, ≥88 cm for women
Show all 11Show fewer
- Triglycerides: ≥150 mg/dL or on treatment for hypertriglyceridemia
- High-Density Lipoprotein (HDL) cholesterol: <40 mg/dL for men, <50 mg/dL for women
- Blood pressure: systolic ≥130 mmHg and diastolic ≥85 mmHg or on treatment for hypertension
- Fasting plasma glucose: ≥100 mg/dL
- Individuals who provide informed consent
Who cannot join
- (based on participant self-report unless medical records are available)
- Pregnancy or lactation
- Currently enrolled in a weight loss program
- Current treatment with antidepressants, medications that affect glucose metabolism or appetite, or immunosuppressant therapy
- History or presence of eating disorders
- Sleep apnea
Show all 9Show fewer
- Elimination Criteria:
- Participants who do not attend more than two sessions of the psychochrononutritional intervention program.
- Participants who decide to withdraw their consent to continue in the study at any time for any reason.
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, 1 recruiting
- Recruiting
Centro Universitario del Sur
Ciudad Guzmán, Jalisco, 49000
About this study
Official title: Effect of a Restricted Time and Psychochrononutritional Feeding Intervention Program on the Nutritional Status of People With Metabolic Syndrome in Ciudad Guzmán
Metabolic syndrome is a cluster of risk factors, including abdominal obesity, high blood pressure, high triglycerides, and insulin resistance, that increase the risk of developing type 2 diabetes and cardiovascular disease. The prevalence of this syndrome is rising in Mexico. Recent research suggests that when we eat is as important as what we eat. Therefore, chrononutritional strategies such as time-restricted eating (TRE), where food intake is confined to a specific daily time window, have been developed and shown promising benefits. However, there are documented barriers to maintaining this nutritional strategy over time. Therefore, this study proposes that combining TRE with a psychochrononutritional program (integrating psychological, chronobiological, and nutritional components) will improve adherence to the nutritional strategy and lead to better health outcomes than only prescribing a specific eating window.
To this end, 64 adults (18-60 years old) with metabolic syndrome will be recruited in Ciudad Guzmán, Jalisco, Mexico. The TRE intervention will last eight weeks and include two groups. One group will undergo a psychochrononutritional intervention, whereas the other will receive only instructions regarding the eating window. Within each group, two subgroups will be formed: one assigned to an 8-hour eating window, and the other to a 10-hour window. Before and after the intervention, anthropometric, biochemical (lipid profile and plasma glucose), clinical (blood pressure), and dietary assessments will be performed. We expect reductions in blood pressure, glucose, triglycerides, and waist circumference as well as better adherence in the psychochrononutritional intervention group.
Read the detailed description
Metabolic syndrome is a condition characterized by risk factors such as abdominal obesity, insulin resistance, hypertension, high triglycerides, and low HDL cholesterol. Together, these factors increase the likelihood of developing type 2 diabetes and cardiovascular disease. Given the growing prevalence of metabolic syndrome in Mexico and in the state of Jalisco, it is essential to develop strategies that contribute to its prevention and treatment.
Whitin this context, chrononutrition has gained prominence as evidence continues to show the benefits of aligning food intake with circadian rhythms. Time-restricted eating (TRE) has been proposed as an effective strategy for preserving and maintaining the body's physiological health. Emerging evidence suggests it is an effective approach for individuals with metabolic syndrome, as it can improve glucose metabolism, reduce abdominal obesity, and lower the risk of developing metabolic syndrome.
The implementation of a TRE plan can be more effective when combined with a psychonutritional intervention, as this can improve adherence to the nutritional treatment and lead to better long-term results.
Therefore, this study aims to determine the effect of a TRE and a psychochrononutritional intervention program on the nutritional status of individuals with metabolic syndrome in Ciudad Guzmán, Jalisco. A randomized controlled trial will be conducted in adult residents, aged 18 to 60 years, of both sexes, diagnosed with metabolic syndrome. The sample size was calculated using a two-mean comparison equation, considering a 10% attrition rate. Resulting in a total sample of 64 participants, 32 for each group.
The study will be carried out in three phases. Phase one will include participants recruitment and confirmation of metabolic syndrome diagnosis. The second phase will integrate a baseline assessment, including anthropometric (weight, percentage of fat and muscle mass, waist circumference) and nutritional measurements, and questionnaires (diet quality index, the Chrononutrition Profile Questionnaire, adherence to treatment and the Pittsburgh Sleep Quality Index). The same variables will be evaluated at the end of the study. Participants will then complete an eight-week restricted-time eating intervention and will be assigned into two groups: one will receive psychonutritional support, and the other will only be given instructions regarding the eating window. Within each group, two subgroups will be created: one will have an 8-hour window, and the other a 10-hour eating window. The third phase will involve a follow up, measuring the same variables taken in phase one.
The data will be analyzed using the statistical software R. Descriptive analyses (means, standard deviations, frequencies, and percentages) will be calculated, followed by a normality test. A paired-samples t-test will be conducted to compare changes before and after the intervention in the following variables: a) anthropometric parameters: body weight, fat and muscle mass, and waist circumference; b) biochemical parameters: fasting plasma glucose, total cholesterol and fractions, and blood pressure; c) nutritional and behavioral variables: eating window and adherence to the eating schedule. In addition, an ANOVA or independent samples t-test will be performed to evaluate the differences between the groups: the group with psychochrononutritional intervention versus the group with minimal intervention, as well as the group with an 8-hour restricted eating window versus a 10-hour restricted eating window.
Expected outcomes include reductions in triglycerides, LDL cholesterol, fasting plasma glucose, blood pressure, and waist circumference, as well as an increase in HDL cholesterol. It is hypothesized that these improvements will be greater in the experimental groups, along with a higher adherence to the intervention. Collectively, these findings will help determine the effect of a TRE intervention combined with a psychochrononutritional approach and assess whether this strategy is a feasible option for improving metabolic health in patients with this condition.
- Conditions
- Metabolic Syndrome
- Being tested
- Time restricted eating, Psychochrononutritional intervention
- Keywords
- Time restricted eating, Eating Behavior, Chrononutrition, Metabolic syndrome, Psychochrononutrition
- Medical subject headings
- Metabolic Syndrome, Intermittent Fasting, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time restricted eatingBehavioural
Also called Time restricted feeding
Behavioral and dietary intervention in which participants are instructed to consume all their food and caloric beverages within a fixed window (8 or 10 hours, depending on arm assignment). Outside of this window, only water or non-caloric beverages are permitted. The intervention will last 8 weeks.
Psychochrononutritional interventionBehavioural
Participants will receive a structured psychochrononutritional intervention consisting of eight weekly sessions. The program will cover the following topics:
- Chrononutrition: The internal clock of eating.
- Food groups and healthy menu planning.
- Portion control: Learning to measure appropriately.
- Effects of sugary drinks.
- Sleep and its impact on eating habits.
- Social and cultural factors in eating habits.
- The relationship between physical activity and nutrition.
- Making informed nutritional decisions.
| Study group | Role | What they receive |
|---|---|---|
| Minimal intervention group | Other | Participants will be instructed to adhere to a specific eating window, with flexibility to select their daily eating-window start and end times, as long as they fall within an 8- or 10-hour period. This intervention will last 8 weeks, during which they are instructed to consume all their caloric intake within the established time window. Receives: Behavioral: Time restricted eating |
| Grupo experimental | Experimental | Participants will be instructed to adhere to an 8- or 10-hour eating window, with flexibility to select their daily eating-window start and end times but must concentrate their caloric intake within that period. Additionally, the group receives a psychochrononutritional intervention consisting of weekly group sessions with an educational and behavioral focus for 8 weeks. Receives: Behavioral: Time restricted eating; Behavioral: Psychochrononutritional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waist circumference
Waist circumference: A decrease in waist circumference is expected, ≤102 cm in men and ≤88 cm in women. Measured in centimeters using a measuring tape at the level of the navel, at the end of a normal exhalation.
Measured: At the beginning (week 1) and end of the intervention (week 8).
Changes in Blood Pressure
Blood Pressure: A decrease in blood pressure of ≤130/85 mmHg is expected. Measurement of systolic and diastolic blood pressure using a digital blood pressure monitor.
Measured: At the beginning (week 1) and end of the intervention (week 8).
Changes in Glucose
Glucose: A decrease in glucose level to <110 mg/dL is expected. Measurement of fasting plasma glucose, measured through a venous blood sample obtained between 7:30 and 8:30 am and processed using an automated colorimetric method.
Measured: At the beginning (week 1) and end of the intervention (week 8).
Changes in HDL cholesterol
HDL cholesterol: An increase in its values is expected, with a normal range of >40 mg/dL in men and >50 mg/dL in woman. The increase will mean better cardiovascular outcomes.
Measurement of HDL cholesterol measured through a venous blood sample obtained between 7:30 and 8:30 am and processed using an automated colorimetric method.
Measured: At the beginning (week 1) and end of the intervention (week 8).
Changes in triglycerides levels
Triglycerides: a decrease in values is expected, with a reference range <150 mg/dL. The decrease will mean better cardiovascular outcomes. Measurement of serum triglycerides measured through a venous blood sample obtained between 7:30 and 8:30 am and processed using an automated colorimetric method.
Measured: At the beginning (week 1) and end of the intervention (week 8).
Treatment Adherence
Degree to which participants follow the recommendations of the intervention program, it will be measured by self-reporting. Adherence is expected four out of seven days a week.
Measured: Monitoring for 8 weeks.
Secondary outcomes (5)
Changes in Body weight
Body weight: An average reduction of 10% in initial body weight is expected at the end of the intervention. Measurement in kilograms using a digital scale. The participant should be barefoot, wearing as little clothing as possible, and preferably fasting.
Measured: At the beginning (week 1) and end of the intervention (week 8).
Body composition analysis
It will be evaluated by electrical bioimpedance (InBody®), comparing the baseline measurement with the final measurement at week 8. A healthy body fat percentage will be taken as a reference point: ≤25% in women and ≤15% in men. Por otro lado, a healthy body muscle considering an increase in relation to healthy reference values: ≥35% in men and ≥25% in women.
Measured: At the beginning (week 1) and end of the intervention (week 8).
Changes in visceral fat
Changes in visceral fat measurement performed by electrical bioimpedance (InBody®).
Measured: At the beginning (week 1) and end of the intervention (week 8).
Mexican Diet Quality Index
The Mexican Diet Quality Index (IACDMx) will be applied, which classifies foods and beverages into 13 groups. One point is assigned to each component if its energy percentage meets the recommendation. The food classification and cut-off points are based on the energy percentage, considering the energy intake recommendation for each group, in relation to the total daily energy intake of 2,500 kcal proposed by the commission. The score is grouped into five categories: ≤5, 6, 7, 8, and ≥9 points.
Measured: At the beginning (week 1) and end of the intervention (week 8).
Sleep quality
Sleep quality will be assessed subjectively using the Pittsburgh Sleep Quality Index (PSQI). This instrument allows for the analysis of qualitative dimensions, such as sleep depth and daytime functioning, as well as quantitative variables (sleep latency, duration, and frequency of awakenings), using a rating scale that ranges from very good to good, poor, and very poor.
Measured: At the beginning (week 1) and end of the intervention (week 8).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start4 Dec 2025
- Primary completionApr 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Patricia Zepeda Salvador, University of Guadalajara
- Investigators
- Yadira V Martínez Vázquez, PhD students, Study chair, University of GuadalajaraAlma G Martínez Moreno, PhD, Study chair, University of GuadalajaraCésar A Gómez Acosta, PhD, Study chair, Universidad de PamplonaAna C Espinoza Gallardo, PhD, Study chair, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389603
- Sponsor's protocol ID
- CIP/T/36/25
- Other IDs
- DCAN/006/2025
- Acronym
- PSICRONUT
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For security and data protection reasons, access to participants' identities is restricted. Sharing identification forms with external researchers contradicts the principle of purpose limitation of consent, which stipulates that personal information will be treated anonymously and privately, ensuring that no data that could re-identify subjects is disclosed outside the authorized research team.
Publications
Manoogian ENC, Wilkinson MJ, O'Neal M, Laing K, Nguyen J, Van D, Rosander A, Pazargadi A, Gutierrez NR, Fleischer JG, Golshan S, Panda S, Taub PR. Time-Restricted Eating in Adults With Metabolic Syndrome : A Randomized Controlled Trial. Ann Intern Med. 2024 Nov;177(11):1462-1470. doi: 10.7326/M24-0859. Epub 2024 Oct 1.
PubMed 39348690
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Restricted Time and Psychochrononutritional Feeding Intervention Program on the Nutritional Status of People With Metabolic Syndrome in Ciudad Guzmán
- ClinicalTrials.gov ID
- NCT07389603
- Acronym / sponsor ID
- PSICRONUT / CIP/T/36/25
- Conditions
- Metabolic Syndrome
- Keywords
- Time restricted eating, Eating Behavior, Chrononutrition, Metabolic syndrome, Psychochrononutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 5 Feb 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.
Metabolic syndrome is a cluster of risk factors, including abdominal obesity, high blood pressure, high triglycerides, and insulin resistance, that increase the risk of developing type 2 diabetes and cardiovascular disease. The prevalence of this syndrome is rising in Mexico. Recent research suggests that when we eat is as important as what we eat. Therefore, chrononutritional strategies such as time-restricted eating (TRE), where food intake is confined to a specific daily time window, have been developed and shown promising benefits. However, there are documented barriers to maintaining this nutritional strategy over time. Therefore, this study proposes that combining TRE with a psychochrononutritional program (integrating psychological, chronobiological, and nutritional components) will improve adherence to the nutritional strategy and lead to better health outcomes than only prescribing a specific eating window.
To this end, 64 adults (18-60 years old) with metabolic syndrome will be recruited in Ciudad Guzmán, Jalisco, Mexico. The TRE intervention will last eight weeks and include two groups. One group will undergo a psychochrononutritional intervention, whereas the other will receive only instructions regarding the eating window. Within each group, two subgroups will be formed: one assigned to an 8-hour eating window, and the other to a 10-hour window. Before and after the intervention, anthropometric, biochemical (lipid profile and plasma glucose), clinical (blood pressure), and dietary assessments will be performed. We expect reductions in blood pressure, glucose, triglycerides, and waist circumference as well as better adherence in the psychochrononutritional intervention group.
Detailed description
Metabolic syndrome is a condition characterized by risk factors such as abdominal obesity, insulin resistance, hypertension, high triglycerides, and low HDL cholesterol. Together, these factors increase the likelihood of developing type 2 diabetes and cardiovascular disease. Given the growing prevalence of metabolic syndrome in Mexico and in the state of Jalisco, it is essential to develop strategies that contribute to its prevention and treatment.
Whitin this context, chrononutrition has gained prominence as evidence continues to show the benefits of aligning food intake with circadian rhythms. Time-restricted eating (TRE) has been proposed as an effective strategy for preserving and maintaining the body's physiological health. Emerging evidence suggests it is an effective approach for individuals with metabolic syndrome, as it can improve glucose metabolism, reduce abdominal obesity, and lower the risk of developing metabolic syndrome.
The implementation of a TRE plan can be more effective when combined with a psychonutritional intervention, as this can improve adherence to the nutritional treatment and lead to better long-term results.
Therefore, this study aims to determine the effect of a TRE and a psychochrononutritional intervention program on the nutritional status of individuals with metabolic syndrome in Ciudad Guzmán, Jalisco. A randomized controlled trial will be conducted in adult residents, aged 18 to 60 years, of both sexes, diagnosed with metabolic syndrome. The sample size was calculated using a two-mean comparison equation, considering a 10% attrition rate. Resulting in a total sample of 64 participants, 32 for each group.
The study will be carried out in three phases. Phase one will include participants recruitment and confirmation of metabolic syndrome diagnosis. The second phase will integrate a baseline assessment, including anthropometric (weight, percentage of fat and muscle mass, waist circumference) and nutritional measurements, and questionnaires (diet quality index, the Chrononutrition Profile Questionnaire, adherence to treatment and the Pittsburgh Sleep Quality Index). The same variables will be evaluated at the end of the study. Participants will then complete an eight-week restricted-time eating intervention and will be assigned into two groups: one will receive psychonutritional support, and the other will only be given instructions regarding the eating window. Within each group, two subgroups will be created: one will have an 8-hour window, and the other a 10-hour eating window. The third phase will involve a follow up, measuring the same variables taken in phase one.
The data will be analyzed using the statistical software R. Descriptive analyses (means, standard deviations, frequencies, and percentages) will be calculated, followed by a normality test. A paired-samples t-test will be conducted to compare changes before and after the intervention in the following variables: a) anthropometric parameters: body weight, fat and muscle mass, and waist circumference; b) biochemical parameters: fasting plasma glucose, total cholesterol and fractions, and blood pressure; c) nutritional and behavioral variables: eating window and adherence to the eating schedule. In addition, an ANOVA or independent samples t-test will be performed to evaluate the differences between the groups: the group with psychochrononutritional intervention versus the group with minimal intervention, as well as the group with an 8-hour restricted eating window versus a 10-hour restricted eating window.
Expected outcomes include reductions in triglycerides, LDL cholesterol, fasting plasma glucose, blood pressure, and waist circumference, as well as an increase in HDL cholesterol. It is hypothesized that these improvements will be greater in the experimental groups, along with a higher adherence to the intervention. Collectively, these findings will help determine the effect of a TRE intervention combined with a psychochrononutritional approach and assess whether this strategy is a feasible option for improving metabolic health in patients with this condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimal intervention group | Other | Behavioral: Time restricted eatingParticipants will be instructed to adhere to a specific eating window, with flexibility to select their daily eating-window start and end times, as long as they fall within an 8- or 10-hour period. This intervention will last 8 weeks, during which they are instructed to consume all their caloric intake within the established time window. |
| Grupo experimental | Experimental | Behavioral: Time restricted eating, Behavioral: Psychochrononutritional interventionParticipants will be instructed to adhere to an 8- or 10-hour eating window, with flexibility to select their daily eating-window start and end times but must concentrate their caloric intake within that period. Additionally, the group receives a psychochrononutritional intervention consisting of weekly group sessions with an educational and behavioral focus for 8 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Age 18 to 60 years
- Both sexes
- Feeding window ≥14 h/day
- Usual sleep duration >6.5 h
- Individuals diagnosed with metabolic syndrome who meet three or more of the criteria from Panel III of the National Cholesterol Education Program's Adult Treatment Guidelines:
Key exclusion criteria (9 listed)
- (based on participant self-report unless medical records are available)
- Participants who do not attend more than two sessions of the psychochrononutritional intervention program.
- Participants who decide to withdraw their consent to continue in the study at any time for any reason.
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 |
|---|---|---|
| Time restricted eatingAlso: Time restricted feedingBehavioral and dietary intervention in which participants are instructed to consume all their food and caloric beverages within a fixed window (8 or 10 hours, depending on arm assignment). Outside of this window, only water or non-caloric beverages are permitted. The intervention will last 8 weeks. | Behavioural | Grupo experimental, Minimal intervention group |
| Psychochrononutritional interventionParticipants will receive a structured psychochrononutritional intervention consisting of eight weekly sessions. The program will cover the following topics: * Chrononutrition: The internal clock of eating. * Food groups and healthy menu planning. * Portion control: Learning to measure appropriately. * Effects of sugary drinks. * Sleep and its impact on eating habits. * Social and cultural factors in eating habits. * The relationship between physical activity and nutrition. * Making informed nutritional decisions. | Behavioural | Grupo experimental |
Primary outcome
Waist circumference
Time frame: At the beginning (week 1) and end of the intervention (week 8).
Waist circumference: A decrease in waist circumference is expected, ≤102 cm in men and ≤88 cm in women. Measured in centimeters using a measuring tape at the level of the navel, at the end of a normal exhalation.
Changes in Blood Pressure
Time frame: At the beginning (week 1) and end of the intervention (week 8).
Blood Pressure: A decrease in blood pressure of ≤130/85 mmHg is expected. Measurement of systolic and diastolic blood pressure using a digital blood pressure monitor.
Changes in Glucose
Time frame: At the beginning (week 1) and end of the intervention (week 8).
Glucose: A decrease in glucose level to <110 mg/dL is expected. Measurement of fasting plasma glucose, measured through a venous blood sample obtained between 7:30 and 8:30 am and processed using an automated colorimetric method.
Changes in HDL cholesterol
Time frame: At the beginning (week 1) and end of the intervention (week 8).
HDL cholesterol: An increase in its values is expected, with a normal range of >40 mg/dL in men and >50 mg/dL in woman. The increase will mean better cardiovascular outcomes. Measurement of HDL cholesterol measured through a venous blood sample obtained between 7:30 and 8:30 am and processed using an automated colorimetric method.
Changes in triglycerides levels
Time frame: At the beginning (week 1) and end of the intervention (week 8).
Triglycerides: a decrease in values is expected, with a reference range <150 mg/dL. The decrease will mean better cardiovascular outcomes. Measurement of serum triglycerides measured through a venous blood sample obtained between 7:30 and 8:30 am and processed using an automated colorimetric method.
Treatment Adherence
Time frame: Monitoring for 8 weeks.
Degree to which participants follow the recommendations of the intervention program, it will be measured by self-reporting. Adherence is expected four out of seven days a week.
5 secondary outcomes
Changes in Body weight
Time frame: At the beginning (week 1) and end of the intervention (week 8).
Body composition analysis
Time frame: At the beginning (week 1) and end of the intervention (week 8).
Changes in visceral fat
Time frame: At the beginning (week 1) and end of the intervention (week 8).
Mexican Diet Quality Index
Time frame: At the beginning (week 1) and end of the intervention (week 8).
Sleep quality
Time frame: At the beginning (week 1) and end of the intervention (week 8).
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 18 Feb 2026.
- Background: PubMed 39348690Manoogian ENC, Wilkinson MJ, O'Neal M, Laing K, Nguyen J, Van D, Rosander A, Pazargadi A, Gutierrez NR, Fleischer JG, Golshan S, Panda S, Taub PR. Time-Restricted Eating in Adults With Metabolic Syndrome : A Randomized Controlled Trial. Ann Intern Med. 2024 Nov;177(11):1462-1470. doi: 10.7326/M24-0859. Epub 2024 Oct 1.
- Individual participant dataSharing planned: No. For security and data protection reasons, access to participants' identities is restricted. Sharing identification forms with external researchers contradicts the principle of purpose limitation of consent, which stipulates that personal information will be treated anonymously and privately, ensuring that no data that could re-identify subjects is disclosed outside the authorized research team.
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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.
Yadira V Martínez Vázquez, PhD students study chair
University of Guadalajara
Alma G Martínez Moreno, PhD study chair
University of Guadalajara
César A Gómez Acosta, PhD study chair
Universidad de Pamplona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time restricted eating and Psychochrononutritional intervention in people with Metabolic Syndrome, run by University of Guadalajara 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 11 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 18 Feb 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. 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 Ana P Zepeda Salvador, PhD (341 575 2222, ana.zepeda@cusur.udg.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Waist circumference (time frame: At the beginning (week 1) and end of the intervention (week 8).). The study lists 6 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 NCT07389603, which also lists 1 linked publication.
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 18 Feb 2026.