NCT05730231Completed
Clinical Trials of Effects of Time Restricted Eating on Health Parameters in Adults
Comparison of Calorie Restriction With Early Time-restricted Eating and Calorie Restriction With Mid-day Time-restricted Eating and Daily Calorie Restriction
Source: ClinicalTrials.gov · Last updated 5 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 108 (actual)
- First submitted
- 6 Feb 2023
- Start date
- 3 Mar 2023
- Primary completion date
- 30 Jun 2023
- Lead sponsor
- University of Primorska
- NCT number
- NCT05730231
What you commit to
- Study type: Interventional
- Participants enrolled: 108
- From 3 Mar 2023 to the primary completion date, 30 Jun 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosis of diabetes
- Eating disorders
- Uncontrolled medical condition due to gastrointestinal, psychiatric, rheumatologic, oncologic, hematologic or endocrine diseases
- History of tumor
- History of serious cardiovascular or cerebrovascular diseases
Other
- Pregnant or plan to be become pregnant
- Lactating women
- Active smoking
- Currently enrolled in a weight-management program
- Taking medicines that may affect weight and appetite
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Primorska, Faculty of Health Sciences Coordinator of this site? Confirm its status | Izola | Slovenia | Unknown status |
Related publications
- Early time-restricted eating with energy restriction has a better effect on body fat mass, diastolic blood pressure, metabolic age and fasting glucose compared to late time-restricted eating with energy restriction and/or energy restriction alone: A 3-month randomized clinical trial.Clin Nutr · 2025 · PMID 40250088
This page is information, not medical advice. Discuss any trial with your doctor.