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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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.

Eligibility

Primary outcome measure(s)

• Waist circumference — At the beginning (week 1) and end of the intervention (week 8).
  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.
• Changes in Blood Pressure — At the beginning (week 1) and end of the intervention (week 8).
  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.
• Changes in Glucose — At the beginning (week 1) and end of the intervention (week 8).
  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.
• Changes in HDL cholesterol — At the beginning (week 1) and end of the intervention (week 8).
  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.
• Changes in triglycerides levels — At the beginning (week 1) and end of the intervention (week 8).
  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.
• Treatment Adherence — Monitoring for 8 weeks.
  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.

Trial sites (1)

More University of Guadalajara trials in Mexico

Other trials for the same condition