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

RecruitingNAAges 18 Years - 60 YearsAllUniversity of Guadalajara
NCT07389603 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 prescrib

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📋 Eligibility rules (as published)
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.
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What it tests

  • Time restricted eating
  • Psychochrononutritional intervention
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Where

1 site
Centro Universitario del Sur
Ciudad Guzmán, Mexico
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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