Time-restricted eating plus psychochrononutrition for people with metabolic syndrome
Effect of a Restricted Time and Psychochrononutritional Feeding Intervention Program on the Nutritional Status of People With Metabolic Syndrome in Ciudad Guzmán
This trial will test whether adding a psychochrononutritional program to time‑restricted eating helps adults with metabolic syndrome stick to the eating schedule and improve waist size, blood pressure, lipids, and blood sugar.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Guadalajara Academic / other |
| Locations | 1 site (Ciudad Guzmán, Jalisco) |
| Trial ID | NCT07389603 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–60 of either sex with a diagnosis of metabolic syndrome (meeting at least three NCEP criteria), a habitual feeding window of 14 hours or more, usual sleep duration over 6.5 hours, and ability to provide informed consent are ideal candidates.
Not a fit: People who are pregnant or breastfeeding, currently enrolled in a weight‑loss program, taking antidepressants or medications that alter glucose or appetite, on immunosuppressants, or otherwise excluded by protocol may not receive benefit from this intervention.
Why it matters
Potential benefit: If successful, the combined program could improve long‑term adherence to time‑restricted eating and reduce abdominal obesity, blood glucose, blood pressure, and triglycerides in people with metabolic syndrome.
How similar studies have performed: Previous trials of time‑restricted eating have shown promising improvements in glucose metabolism and abdominal obesity, but combining TRE with a formal psychochrononutritional behavioral program is a more novel approach with limited direct prior testing.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ciudad Guzmán, Jalisco
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.