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NCT05730231
Clinical Trials of Effects of Time Restricted Eating on Health Parameters in Adults
Conditions: Time Restricted Feeding, Overweight and Obesity, Inflammation, Hypercholesterolemia, Hypertension, Hyperglycemia, Antioxidative Stress, Metabolic Syndrome, Microbial Colonization
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 90
Sponsor: University of Primorska
Location: Slovenia
Summary
In a randomized controlled trial we will research the effect of calorie restriction with early and mid-day time-restricted eating (TRE) and daily calorie restriction on weight loss and human health parameters.
Participants will be divided into three groups: early time-restriction group (8:00 AM to 4:00 PM), mid-day restriction group (1:00 PM to 9:00 PM) and daily calorie restriction group (8:00 AM to 9:00 PM).
Participants will follow dietary strategy with three planned meals and calorie restriction.
Anthropometrical and biochemical parameters will be measured at baseline, after one month, two months and at after three months of intervention.
Resting metabolic rate, ultrasound scan of abdomen and ultrasound scan of carotid arteries will be measured at baseline and after three months of intervention.
In addition, stool samples will be also taken at baseline and after three months of intervention.
Eligibility Criteria
Inclusion Criteria:BMI 25-35 kg/m2+ one of the following criteria:Increased waist circumference ≥ 94 cm in men and ≥ 80 cm in womenFasting plasma glucose > 5,6 mmol/LElevated fasting plasma triglycerides 1,7 mmol/lReduced high-density lipoprotein (HDL)-cholesterol < 1,0 mmol/l for men, < 1,3 mmol/l for womenElevated blood pressure, systolic blood pressure > 130 mm Hg and diastolic blood pressure > 85 mm HgWithout medicals for hypertension and hypercholesterolemiaMorning or afternoon working timeExclusion Criteria:Pregnant or plan to be become pregnantLactating womenActive smokingDiagnosis of diabetesEating disordersCurrently enrolled in a weight-management programUncontrolled medical condition due to gastrointestinal, psychiatric, rheumatologic, oncologic, hematologic or endocrine diseasesHistory of tumorHistory of serious cardiovascular or cerebrovascular diseasesTaking medicines that may affect weight and appetite
Source: ClinicalTrials.gov (NCT05730231). StuddyBuddy aggregates publicly available trial information.