Effects of Restricted-time and Psychochrononutritional Feeding in People With Metabolic Syndrome

NCT07389603 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-02-18

No results posted yet for this study

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.

Conditions

  • Metabolic Syndrome

Interventions

BEHAVIORAL

Time restricted eating

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.

BEHAVIORAL

Psychochrononutritional intervention

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.

Sponsors & Collaborators

  • University of Guadalajara

    lead OTHER

Principal Investigators

  • Yadira V Martínez Vázquez, PhD students · University of Guadalajara

  • Alma G Martínez Moreno, PhD · University of Guadalajara

  • César A Gómez Acosta, PhD · Universidad de Pamplona

  • Ana C Espinoza Gallardo, PhD · University of Guadalajara

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-04
Primary Completion
2026-04-30
Completion
2026-06-30

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07389603 on ClinicalTrials.gov