Impact of Time-Restricted Eating on Metabolic Homeostasis, Inflammation and Oxidative Stress in M… (NCT04328233) | Clinical Trial Compass
UnknownNot Applicable
Impact of Time-Restricted Eating on Metabolic Homeostasis, Inflammation and Oxidative Stress in Metabolic Syndrome
Poland30 participantsStarted 2019-10-31
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Metabolic syndrome, defined as the presence of elevated fasting plasma glucose ≥ 100 mg/dL and two or more of the following criteria:
✓. BMI \> 25
✓. Duration of eating period ≥ 14 hours/day.
✓. Own a Smartphone with Apple Operating System (OS) or Android OS.
Exclusion criteria
✕. Diagnosis of diabetes.
✕. Pregnant or lactating women.
✕. Active smoking or illicit drug use or history of treatment for alcohol abuse.
✕. Shift work.
✕. Caregivers for dependent requiring nocturnal care.
✕. Planned travel over time zones during the study period.
✕. History of major adverse cardiovascular event within the past 1 year (acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure, stroke/transient ischemic attack) or current uncontrolled arrhythmia.
✕. Uncontrolled medical conditions due to rheumatologic, hematologic, oncologic, infectious, gastrointestinal, psychiatric, nephrological, or endocrine diseases.