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

NCT07389603 | Recruiting DMC

• 2 other identifiers: CIP/T/36/25DCAN/006/2025
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

Time restricted eating; Eating Behavior; Chrononutrition; Metabolic syndrome; Psychochrononutrition

Outcome Measures

Primary Outcomes (6)

• Waist circumference

  Waist circumference: A decrease in waist circumference is expected, ≤102 cm in men and ≤88 cm in women. Measured in centimeters using a measuring tape at the level of the navel, at the end of a normal exhalation.

  At the beginning (week 1) and end of the intervention (week 8).

• Changes in Blood Pressure

  Blood Pressure: A decrease in blood pressure of ≤130/85 mmHg is expected. Measurement of systolic and diastolic blood pressure using a digital blood pressure monitor.

  At the beginning (week 1) and end of the intervention (week 8).

• Changes in Glucose

  Glucose: A decrease in glucose level to \<110 mg/dL is expected. Measurement of fasting plasma glucose, measured through a venous blood sample obtained between 7:30 and 8:30 am and processed using an automated colorimetric method.

  At the beginning (week 1) and end of the intervention (week 8).

• Changes in HDL cholesterol

  HDL cholesterol: An increase in its values is expected, with a normal range of \>40 mg/dL in men and \>50 mg/dL in woman. The increase will mean better cardiovascular outcomes. Measurement of HDL cholesterol measured through a venous blood sample obtained between 7:30 and 8:30 am and processed using an automated colorimetric method.

  At the beginning (week 1) and end of the intervention (week 8).

• Changes in triglycerides levels

  Triglycerides: a decrease in values is expected, with a reference range \<150 mg/dL. The decrease will mean better cardiovascular outcomes. Measurement of serum triglycerides measured through a venous blood sample obtained between 7:30 and 8:30 am and processed using an automated colorimetric method.

  At the beginning (week 1) and end of the intervention (week 8).

• Treatment Adherence

  Degree to which participants follow the recommendations of the intervention program, it will be measured by self-reporting. Adherence is expected four out of seven days a week.

  Monitoring for 8 weeks.

Secondary Outcomes (5)

• Changes in Body weight

  At the beginning (week 1) and end of the intervention (week 8).

• Body composition analysis

  At the beginning (week 1) and end of the intervention (week 8).

• Changes in visceral fat

  At the beginning (week 1) and end of the intervention (week 8).

• Mexican Diet Quality Index

  At the beginning (week 1) and end of the intervention (week 8).

• Sleep quality

  At the beginning (week 1) and end of the intervention (week 8).

Study Arms (2)

Minimal intervention group

OTHER

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.

Behavioral: Time restricted eating

Grupo experimental

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.

Behavioral: Time restricted eating; Behavioral: Psychochrononutritional intervention

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.

Also known as: Time restricted feeding

Grupo experimental; Minimal intervention group

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.

Grupo experimental

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• (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.

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

Centro Universitario del Sur

Ciudad Guzmán, Jalisco, 49000, Mexico

RECRUITING

Related Publications (1)

• Manoogian ENC, Wilkinson MJ, O'Neal M, Laing K, Nguyen J, Van D, Rosander A, Pazargadi A, Gutierrez NR, Fleischer JG, Golshan S, Panda S, Taub PR. Time-Restricted Eating in Adults With Metabolic Syndrome : A Randomized Controlled Trial. Ann Intern Med. 2024 Nov;177(11):1462-1470. doi: 10.7326/M24-0859. Epub 2024 Oct 1.

  PMID: 39348690 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome; Intermittent Fasting; Feeding Behavior

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Fasting; Behavior; Behavior, Animal

Study Officials

• Yadira V Martínez Vázquez, PhD students

  University of Guadalajara

  STUDY CHAIR

• Alma G Martínez Moreno, PhD

  University of Guadalajara

  STUDY CHAIR

• César A Gómez Acosta, PhD

  Universidad de Pamplona

  STUDY CHAIR

• Ana C Espinoza Gallardo, PhD

  University of Guadalajara

  STUDY CHAIR

Central Study Contacts

Ana P Zepeda Salvador, PhD

CONTACT

341 575 2222; ana.zepeda@cusur.udg.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD- Research Professor

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 5, 2026
• Study Start: December 4, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)