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 range

18 Years – 60 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Time Restricted Feeding trials