Clinical trial NCT05730231: Clinical Trials of Effects of Time Restricted Eating on Health Parameters in Adults
Official title: Comparison of Calorie Restriction With Early Time-restricted Eating and Calorie Restriction With Mid-day Time-restricted Eating and Daily Calorie Restriction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Time Restricted Feeding
Overweight and Obesity
Inflammation
Hypercholesterolemia
Hypertension
Hyperglycemia
Antioxidative Stress
Metabolic Syndrome
Microbial Colonization
Keywords: time-restricted eating
calorie restriction
metabolic syndrome
overweight and obesity
dietary strategy
Lead sponsor: University of Primorska
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

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 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

Primary outcomes:
measure: Change in Body Weight
timeFrame: three months
Secondary outcomes:
measure: Change in Body Fat
timeFrame: three months
measure: Changes in Visceral Fat Rating
timeFrame: three months
measure: Changes in Muscle mass
timeFrame: three months
measure: LDL Cholesterol
timeFrame: three months
measure: Inflammation
timeFrame: three months
measure: Glucose levels
timeFrame: three months
measure: Resting metabolic rate
timeFrame: three months
measure: ultrasound scan of abdomen
timeFrame: three months
measure: ultrasound scan of carotid arteries
timeFrame: three months
measure: Antioxidative potential
timeFrame: three months
measure: Blood Pressure
timeFrame: three months
Other outcomes:
Locations:
city: Izola
country: Slovenia
facility: University of Primorska, Faculty of Health Sciences
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.