CompletedNot Applicable

Clinical Trials of Effects of Time Restricted Eating on Health Parameters in Adults

Slovenia108 participantsStarted 2023-03-03

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * BMI 25-35 kg/m2 \+ one of the following criteria: * Increased waist circumference ≥ 94 cm in men and ≥ 80 cm in women * Fasting plasma glucose \> 5,6 mmol/L * Elevated fasting plasma triglycerides 1,7 mmol/l * Reduced high-density lipoprotein (HDL)-cholesterol \< 1,0 mmol/l for men, \< 1,3 mmol/l for women * Elevated blood pressure, systolic blood pressure \> 130 mm Hg and diastolic blood pressure \> 85 mm Hg * Without medicals for hypertension and hypercholesterolemia * Morning or afternoon working time Exclusion Criteria: * Pregnant or plan to be become pregnant * Lactating women * Active smoking * Diagnosis of diabetes * Eating disorders * Currently enrolled in a weight-management program * Uncontrolled medical condition due to gastrointestinal, psychiatric, rheumatologic, oncologic, hematologic or endocrine diseases * History of tumor * History of serious cardiovascular or cerebrovascular diseases * Taking medicines that may affect weight and appetite

What they're measuring

Change in Body Weight

Timeframe: three months

Trial details

NCT IDNCT05730231

SponsorUniversity of Primorska

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-30