Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Obesity has become one of the world's most common diseases and is a major global public health challenge. Obesity contributes to an increased risk of developing various chronic diseases, such as diabetes, metabolic syndrome, hypertension, cardiovascular and kidney diseases and many others. Reducing excess body weight and improving eating habits decreases risk of disease and mortality. A lot of dietary strategies for weight loss are known and most of them are based on daily calorie restriction. Recently, an increasingly popular dietary strategy has been "time restricted eating (TRE)". In this strategy, all calorie intake is restricted within a consistent interval of less than 12 hours (4 - 10 hours). Eating window is limited to early part of the day - early TRE or mid-day TRE. Research shows that TRE has a number of beneficial effect on individuals, including weight loss, improvement of insulin sensitivity, hypercholesterolaemia, circadian rhythm of hormone secretion and other. Which TRE (early or mid-day TRE) has better health effects is still being investigated. It is also not clear how the timing, number and composition of individual meals affect on the health indicators, mentioned previously.
Therefore, the aim of our study is to evaluate and compare the effects of calorie restriction with early and mid-day time-restricted eating (TRE) and daily calorie restriction on weight loss and human health parameters in adults with at least two components of metabolic syndrome and yet not receiving any medication. The components of metabolic syndrome (lipid profile, blood pressure, anthropometry, inflammation status, glucose levels), antioxidative status, hormones (leptin, ghrelin, cortisol, insulin, adiponectin, cholecystokinin, melatonin, BDNF, IGF-1) will be measured. In addition changes in gene expression of different proteins will be examined. Moreover, stool samples will be also taken at baseline and after three months of intervention.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early time-restricted eating with calorie restriction | Experimental | Participants will follow calorie restriction with early day time-restricted eating protocol with three planned meals from 8:00 AM to 4:00 PM. |
|
| Mid-day time-restricted eating with calorie restriction | Experimental | Participants will follow calorie restriction with mid-day time-restricted eating protocol with three planned meals from 1:00 PM to 9:00 PM. |
|
| Daily calorie restriction | Experimental | Participants will follow daily calorie restriction protocol with three planned meals from 8:00 AM to 9:00 PM. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Effects of calorie restriction and time-restricted eating on human health | Other | Calorie restriction plan will be prepared for each participant. After nutritional data collection at baseline, all participant will attend educational sessions about healthy diet and beneficial effects of time-restricted eating. To estimate total energy needs, individuals' RMR will be measured from indirect calorimeter and multiplied by the appropriate factor of physical activity (from 1.3 to 1.6), and then a reduction of 200-500 kcal will be made. Macronutrient composition of the diet will be approximately 45-55% of carbohydrate, 30-35% of fat, and 15-20% of protein. 30% of daily energy intake will be consumed by breakfast, 40% by lunch and 30% by dinner. During posting participants will be allowed to consume only water and herbal infusions without added sugars or sweeteners. Dietary intake of participants will be followed during the study using a 24-h recall. Dietary data will be analysed using the Open Platform for Clinical Nutrition accessible through the website http://opkp.si/. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | Changes in body weight (in kilograms) from baseline to week twelve measured with bioelectrical impedance analysis (BIA) Tanita MC-980MA | three months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Fat | Changes in percentage of body fat from baseline to week twelve measured with bioelectrical impedance analysis (BIA) Tanita MC-980MA | three months |
| Changes in Visceral Fat Rating |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Primorska, Faculty of Health Sciences | Izola | 6310 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34550357 | Background | Manoogian ENC, Chow LS, Taub PR, Laferrere B, Panda S. Time-restricted Eating for the Prevention and Management of Metabolic Diseases. Endocr Rev. 2022 Mar 9;43(2):405-436. doi: 10.1210/endrev/bnab027. | |
| 35443107 | Background | Liu D, Huang Y, Huang C, Yang S, Wei X, Zhang P, Guo D, Lin J, Xu B, Li C, He H, He J, Liu S, Shi L, Xue Y, Zhang H. Calorie Restriction with or without Time-Restricted Eating in Weight Loss. N Engl J Med. 2022 Apr 21;386(16):1495-1504. doi: 10.1056/NEJMoa2114833. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Changes in visceral fat rating (index) from baseline to week twelve measured with bioelectrical impedance analysis (BIA) Tanita MC-980MA. The range of the visceral fat rating (scale) is from 0 to 30. Higher scores indicate excess visceral fat (a worse outcome).
| three months |
| Changes in Muscle mass | Changes in muscle mass (in kilograms) from baseline to week twelve measured with bioelectrical impedance analysis (BIA) Tanita MC-980MA | three months |
| LDL Cholesterol | Changes in LDL cholesterol measured by biochemical analyzer Cobass | three months |
| Inflammation | Changes in C-reactive protein levels measured by biochemical analyzer Cobass | three months |
| Glucose levels | Changes in glucose levels measured by biochemical analyzer Cobass | three months |
| Resting metabolic rate | Changes in resting metabolic rate measured by (MedGem® Microlife, Medical Home Solutions, Inc., Golden, CO) | three months |
| ultrasound scan of abdomen | ultrasound scan of abdomen measured by Resona 7 Mindray | three months |
| ultrasound scan of carotid arteries | ultrasound scan of carotid arteries measured by Resona 7 Mindray | three months |
| Antioxidative potential | Antioxidative potential will be determined with DPPH radical measurement. | three months |
| Blood Pressure | Changes in systolic blood pressure measured by blood pressure device (Omron M3) | three months |
| 33498955 | Background | Swiatkiewicz I, Mila-Kierzenkowska C, Wozniak A, Szewczyk-Golec K, Nuszkiewicz J, Wroblewska J, Rajewski P, Eussen SJPM, Faerch K, Manoogian ENC, Panda S, Taub PR. Pilot Clinical Trial of Time-Restricted Eating in Patients with Metabolic Syndrome. Nutrients. 2021 Jan 24;13(2):346. doi: 10.3390/nu13020346. |
| 36034217 | Background | Zhang LM, Liu Z, Wang JQ, Li RQ, Ren JY, Gao X, Lv SS, Liang LY, Zhang F, Yin BW, Sun Y, Tian H, Zhu HC, Zhou YT, Ma YX. Randomized controlled trial for time-restricted eating in overweight and obese young adults. iScience. 2022 Aug 5;25(9):104870. doi: 10.1016/j.isci.2022.104870. eCollection 2022 Sep 16. |
| 40731289 | Derived | Habe B, Cresnovar T, Petelin A, Kenig S, Mohorko N, Jenko Praznikar Z. Comparing the influence of early and late time-restricted eating with energy restriction and energy restriction alone on cardiometabolic markers, metabolic hormones and appetite in adults with overweight/obesity: per-protocol analysis of a 3-month randomized clinical trial. Nutr Metab (Lond). 2025 Jul 29;22(1):85. doi: 10.1186/s12986-025-00984-3. |
| 40250088 | Derived | Cresnovar T, Habe B, Mohorko N, Kenig S, Jenko Praznikar Z, Petelin A. 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 Jun;49:57-68. doi: 10.1016/j.clnu.2025.04.001. Epub 2025 Apr 8. |
| ID | Term |
|---|---|
| D000093763 | Intermittent Fasting |
| D050177 | Overweight |
| D009765 | Obesity |
| D007249 | Inflammation |
| D006937 | Hypercholesterolemia |
| D006973 | Hypertension |
| D006943 | Hyperglycemia |
| D024821 | Metabolic Syndrome |
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D007239 | Infections |
| D020969 | Disease Attributes |
Not provided
Not provided