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Life sciences · Interventional Study
ClinicalTrials.gov · October 1, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT04328233). This is a study registration, not published results. Lead sponsor: Nicolaus Copernicus University. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 27 participants (ACTUAL). Conditions: Metabolic Syndrome, Overweight or Obesity, PreDiabetes, Weight Loss, Quality of Life. Interventions: BEHAVIORAL: Time-Restricted Eating. Primary outcome measures: Change in body weight , Baseline and after 14 weeks; Change in fasting glucose concentration , Baseline and after 14 weeks. Brief summary: The main purpose of the clinical trial is to determine the health impact of a dietary intervention known as time-restricted eating (TRE) in patients with metabolic syndrome (defined as the presence of elevated fasting plasma glucose and two or more of the following criteria: increased waist circumference, elevated fasting plasma triglycerides, reduced high-density lipoprotein-cholesterol, elevated blood pressure) and self-reported dietary intake of ≥14 hours per day. Participants will reduce the amount of time they eat to 10 hours per day over a 12-week monitored intervention followed by a 12-week self-directed intervention and will log their dietary intake using a smartphone application (myCircadianClock (mCC) app). Glucose homeostasis (blood glucose levels will be monitored continuously for 2 weeks at the baseline, at the end of the monitored intervention, and at the end of the self-directed intervention using a continuous glucose monitor), and other metabolic, neuroendocrine, inflammatory and oxidative stress/antioxidant defense biomarkers, body weight and composition, blood pressure, heart rate, sleep and activity (using mCC app), personal sense of wellness and dietary timing (using health questionnaires) will be evaluated at the baseline, at the end of the monitored intervention, and at the end of the self-directed intervention.