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

Sponsor
University of Guadalajara
Study ID
NCT07389603
Status
Recruiting
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Conditions

  • Metabolic Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Time restricted eating — BEHAVIORAL
    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 intervention — BEHAVIORAL
    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 Details

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.

Key Dates

First listed
Feb 5, 2026
Start date
Dec 4, 2025
Status verified
Jan 2026
Primary completion
Apr 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Minimal intervention group
    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.
  • Experimental: Grupo 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.

Primary Outcome Measure

Waist circumference [ Time Frame: At the beginning (week 1) and end of the intervention (week 8). ]

Central Contacts

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