An interventional study of Time-Restricted Eating in Metabolic Syndrome, Overweight or Obesity and PreDiabetes, sponsored by Nicolaus Copernicus University. Completed at 1 site in Poland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Nicolaus Copernicus University · Not applicable, Interventional, and Prevention
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.
Metabolic syndrome occurs in approximately 30% of adults and is associated with increased risk of cardiovascular disease and type 2 diabetes. Circadian rhythm disruption due to lifestyle including erratic eating patterns may lead to metabolic and neuroendocrine dysfunction, inflammation, oxidative stress, and cardiometabolic diseases. Maintaining a daily rhythm of eating and fasting cycles sustains a robust circadian rhythm which improves cellular bioenergetics and metabolism. Recent studies support the notion that restricting a period of food intake to 8-12 hours a day (time-restricted eating, TRE) can prevent and reverse obesity and metabolic dysfunction.
The main purpose of the clinical trial is to determine the health impact of 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, developed by the Salk Institute for Biological Studies). The participants will select a 10-h eating window that best suits their lifestyle. All food/beverages except water must be consumed within the time-interval. No further dietary restrictions will be applied. The participants will be provided with behavioral nutritional counseling by a dietician. 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. The investigators will assess for compliance with TRE using mCC app.
1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.
This study's enrollment of 27 is below the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →Nicolaus Copernicus University is the lead sponsor of 19 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Metabolic syndrome, defined as the presence of elevated fasting plasma glucose ≥ 100 mg/dL and two or more of the following criteria:
Elevated waist circumference: ≥ 102 cm in men, ≥ 88 cm in women; Fasting plasma triglycerides ≥ 150 mg/dL (or on drug treatment for elevated triglycerides); Reduced High-density lipoprotein (HDL)-cholesterol \< 40 mg/dL in men, \< 50 mg/dL in women (or drug treatment for reduced HDL-cholesterol); Elevated blood pressure, Systolic blood pressure ≥ 130 mm Hg and/or diastolic blood pressure ≥ 85 mm Hg (or drug treatment for hypertension).
Exclusion Criteria:
Behavioral: Time-Restricted Eating
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 (mCC app). The participants will select a 10-h eating window that best suits their lifestyle. All food/beverages except water must be consumed within the time-interval. No further dietary restrictions will be applied. The participants will be provided with behavioral nutritional counseling by a dietician.
Change in body weight
Body weight (kg) as measured in fasted state on a digital scale
Time frame: Baseline and after 14 weeks
Change in fasting glucose concentration
Fasting plasma glucose concentration (mg/dl)
Time frame: Baseline and after 14 weeks
Body weight
Body weight (kg) as measured in fasted state on a digital scale
Time frame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Body mass index
Body mass index (kg/m\^2) as calculated from body weight (kg) and height (m)
Time frame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Mean glucose
Glucose levels as measured by continuous glucose monitor (mg/dl) for 14 days at baseline, after 14 weeks, and after 26 weeks
Time frame: Changes from baseline. Measured at baseline, after 14 weeks, and after 26 weeks
Fasting glucose
Fasting glucose levels as measured by continuous glucose monitor (mg/dl) for 14 days at baseline, after 14 weeks, and after 26 weeks
Time frame: Changes from baseline. Measured at baseline, after 14 weeks, and after 26 weeks
Lipids
Fasting blood concentrations of lipids: total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl)
Time frame: Changes from baseline. Measured in the blood in the fasted state at baseline, after 14 weeks, and after 26 weeks
Fat mass
Fat mass percentage (%) as measured by body composition analyzer (using bioelectric impendence technology)
Time frame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
HbA1c
HbA1c (%) assessed from blood samples
Time frame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Metabolic and neuroendocrine biomarkers
Fasting blood concentrations of metabolic and neuroendocrine biomarkers including but not limited to: free fatty acids, insulin, insulin-like growth factor-1, resistin, adiponectin, leptin, visfatin, irisin, ghrelin, omentin-1, and melatonin
Time frame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Inflammatory biomarkers
Fasting blood concentrations of inflammatory biomarkers including but not limited to: high sensitivity C-reactive protein, interleukin-6, interleukin-8, interleukin-10, tumor necrosis factor-α, tumor growth factor-β1, growth/differentiation factor 15
Time frame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Oxidative stress/antioxidant defense biomarkers
Fasting blood concentrations of oxidative stress/antioxidant defense biomarkers including but not limited to: superoxide dismutase-1, catalase, glutathione peroxidase, oxidized LDL, thiobarbituric acid reactive substances, conjugated dienes, malondialdehyde, 4-hydroxynonenal, vitamin A, and vitamin E
Time frame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Waist circumference
Waist circumference (cm) as measured using tape measure
Time frame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Blood pressure
Systolic and diastolic blood pressure (mmHg) measured under resting and fasting conditions
Time frame: Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
Heart rate
Heart rate (bpm) measured under resting conditions during measurements of blood pressure
Time frame: Changes from baseline. Measured at baseline, after 14 weeks, and after 26 weeks
Energy intake
Energy intake (kcal/day) assessed from diet records
Time frame: Registered at baseline, after 14 weeks, and after 26 weeks
Timing of dietary intake
Timing of dietary intake (hh:mm) assessed from diet records and from the chrono-nutrition questionnaire
Time frame: Changes from baseline. Registered at baseline, after 14 weeks, and after 26 weeks
Self-reported sleepiness
Self-reported sleepiness as assessed from the questionnaire the Epworth Sleepiness Scale
Time frame: Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
Self-reported sleep quality
Self-reported sleep quality as assessed from the questionnaire Pittsburgh Sleep Quality Index
Time frame: Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
Self-reported chronotype
Self-reported chronotype as assessed from the Munich Chronotype Questionnaire
Time frame: Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
Self-reported overall health and wellbeing
Self-reported overall health and wellbeing as assessed from the questionnaire Self-reported health (SF-36 health survey)
Time frame: Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
Duration of eating period
Duration from the first to last caloric intake over 24-hour cycle, collected via the smartphone app (mCC app)
Time frame: Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Nicolaus Copernicus University