Time-restricted eating plus psychochrononutrition for people with metabolic syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial will enroll 64 adults aged 18–60 with metabolic syndrome in Ciudad Guzmán, Jalisco, and compare time‑restricted eating (a shortened daily feeding window) alone versus time‑restricted eating combined with a psychochrononutritional program that integrates psychological, chronobiological, and nutritional support. Participants will be randomized to one of the two intervention arms and followed for changes in adherence to the feeding window and metabolic measures that define metabolic syndrome. The study will collect anthropometric, blood pressure, and blood biomarker data to measure changes in waist circumference, triglycerides, HDL, fasting glucose, and blood pressure. The intervention aims to improve both behavioral adherence and metabolic outcomes through tailored counseling and timing-based nutritional guidance.

Why it matters

Who can join: the full rules

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.

Where it's running

• Centro Universitario del Sur
  Ciudad Guzmán, Jalisco, Mexico Recruiting

Study contacts

• Study coordinator: Ana P Zepeda Salvador, PhD
• Email: ana.zepeda@cusur.udg.mx
• Phone: 341 575 2222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.