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

Hypertension Clinical Trial

— TRE  

Official title:

Comparison of Calorie Restriction With Early Time-restricted Eating and Calorie Restriction With Mid-day Time-restricted Eating and Daily Calorie Restriction

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05730231
• Other study ID #: TRE_Clinical
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 3, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2023
• Source: University of Primorska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Hypercholesterolemia
• Hyperglycemia
• Hypertension
• Infections
• Inflammation
• Metabolic Syndrome
• Microbial Colonization
• Overweight
• Overweight and Obesity
• Time Restricted Feeding

Intervention

Other:
• Effects of calorie restriction and time-restricted eating on human health
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/.

Locations

Country	Name	City	State
Slovenia	University of Primorska, Faculty of Health Sciences	Izola

Sponsors (1)

Lead Sponsor	Collaborator
University of Primorska

Country where clinical trial is conducted

Slovenia, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Changes in Visceral Fat Rating	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
Secondary	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
Secondary	LDL Cholesterol	Changes in LDL cholesterol measured by biochemical analyzer Cobass	three months
Secondary	Inflammation	Changes in C-reactive protein levels measured by biochemical analyzer Cobass	three months
Secondary	Glucose levels	Changes in glucose levels measured by biochemical analyzer Cobass	three months
Secondary	Resting metabolic rate	Changes in resting metabolic rate measured by (MedGem® Microlife, Medical Home Solutions, Inc., Golden, CO)	three months
Secondary	ultrasound scan of abdomen	ultrasound scan of abdomen measured by Resona 7 Mindray	three months
Secondary	ultrasound scan of carotid arteries	ultrasound scan of carotid arteries measured by Resona 7 Mindray	three months
Secondary	Antioxidative potential	Antioxidative potential will be determined with DPPH radical measurement.	three months
Secondary	Blood Pressure	Changes in systolic blood pressure measured by blood pressure device (Omron M3)	three months