NCT07389603 Effects of Restricted-time and Psychochrononutritional Feeding in People With Metabolic Syndrome
| NCT ID | NCT07389603 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Guadalajara |
| Condition | Metabolic Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2025-12-04 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 64 participants in total. It began in 2025-12-04 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * (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 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.
Contact & Investigator
Yadira V Martínez Vázquez, PhD students
STUDY CHAIR
University of Guadalajara
Frequently Asked Questions
Who can join the NCT07389603 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Metabolic Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07389603 currently recruiting?
Yes, NCT07389603 is actively recruiting participants. Contact the research team at ana.zepeda@cusur.udg.mx for enrollment information.
Where is the NCT07389603 trial being conducted?
This trial is being conducted at Ciudad Guzmán, Mexico.
Who is sponsoring the NCT07389603 clinical trial?
NCT07389603 is sponsored by University of Guadalajara. The principal investigator is Yadira V Martínez Vázquez, PhD students at University of Guadalajara. The trial plans to enroll 64 participants.