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TrialNo phaseCompleted

Impact of Time-Restricted Eating on Metabolic Homeostasis, Inflammation and Oxidative Stress in Metabolic Syndrome (TREMNIOS)

Impact of Time-Restricted Eating on Metabolic and Neuroendocrine Homeostasis, Inflammation and Oxidative Stress in Patients With Metabolic Syndrome: the TREMNIOS Pilot Clinical Trial

Sponsor
Nicolaus Copernicus University (Academic or other)
Enrolment
27 enrolled
Conditions
Metabolic Syndrome; Overweight or Obesity; PreDiabetes; Weight Loss; Quality of Life
Interventions
Time-Restricted Eating
Ages
adults, older adults
Registry
NCT04328233

From the registry

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…

Primary outcomes

  • Change in body weight
  • Change in fasting glucose concentration
Full record on ClinicalTrials.gov