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

Primary Purpose

Time Restricted Feeding, Overweight and Obesity, Inflammation

Status
Active
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Effects of calorie restriction and time-restricted eating on human health
Sponsored by
University of Primorska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Time Restricted Feeding focused on measuring time-restricted eating, calorie restriction, metabolic syndrome, overweight and obesity, dietary strategy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Primorska, Faculty of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Early time-restricted eating with calorie restriction

Mid-day time-restricted eating with calorie restriction

Daily calorie restriction

Arm Description

Participants will follow calorie restriction with early day time-restricted eating protocol with three planned meals from 8:00 AM to 4:00 PM.

Participants will follow calorie restriction with mid-day time-restricted eating protocol with three planned meals from 1:00 PM to 9:00 PM.

Participants will follow daily calorie restriction protocol with three planned meals from 8:00 AM to 9:00 PM.

Outcomes

Primary Outcome Measures

Change in Body Weight
Changes in body weight (in kilograms) from baseline to week twelve measured with bioelectrical impedance analysis (BIA) Tanita MC-980MA

Secondary Outcome Measures

Change in Body Fat
Changes in percentage of body fat from baseline to week twelve measured with bioelectrical impedance analysis (BIA) Tanita MC-980MA
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).
Changes in Muscle mass
Changes in muscle mass (in kilograms) from baseline to week twelve measured with bioelectrical impedance analysis (BIA) Tanita MC-980MA
LDL Cholesterol
Changes in LDL cholesterol measured by biochemical analyzer Cobass
Inflammation
Changes in C-reactive protein levels measured by biochemical analyzer Cobass
Glucose levels
Changes in glucose levels measured by biochemical analyzer Cobass
Resting metabolic rate
Changes in resting metabolic rate measured by (MedGem® Microlife, Medical Home Solutions, Inc., Golden, CO)
ultrasound scan of abdomen
ultrasound scan of abdomen measured by Resona 7 Mindray
ultrasound scan of carotid arteries
ultrasound scan of carotid arteries measured by Resona 7 Mindray
Antioxidative potential
Antioxidative potential will be determined with DPPH radical measurement.
Blood Pressure
Changes in systolic blood pressure measured by blood pressure device (Omron M3)

Full Information

First Posted
February 6, 2023
Last Updated
August 7, 2023
Sponsor
University of Primorska
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1. Study Identification

Unique Protocol Identification Number
NCT05730231
Brief Title
Clinical Trials of Effects of Time Restricted Eating on Health Parameters in Adults
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 3, 2023 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Primorska

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early time-restricted eating with calorie restriction
Arm Type
Experimental
Arm Description
Participants will follow calorie restriction with early day time-restricted eating protocol with three planned meals from 8:00 AM to 4:00 PM.
Arm Title
Mid-day time-restricted eating with calorie restriction
Arm Type
Experimental
Arm Description
Participants will follow calorie restriction with mid-day time-restricted eating protocol with three planned meals from 1:00 PM to 9:00 PM.
Arm Title
Daily calorie restriction
Arm Type
Experimental
Arm Description
Participants will follow daily calorie restriction protocol with three planned meals from 8:00 AM to 9:00 PM.
Intervention Type
Other
Intervention Name(s)
Effects of calorie restriction and time-restricted eating on human health
Intervention Description
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/.
Primary Outcome Measure Information:
Title
Change in Body Weight
Description
Changes in body weight (in kilograms) from baseline to week twelve measured with bioelectrical impedance analysis (BIA) Tanita MC-980MA
Time Frame
three months
Secondary Outcome Measure Information:
Title
Change in Body Fat
Description
Changes in percentage of body fat from baseline to week twelve measured with bioelectrical impedance analysis (BIA) Tanita MC-980MA
Time Frame
three months
Title
Changes in Visceral Fat Rating
Description
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).
Time Frame
three months
Title
Changes in Muscle mass
Description
Changes in muscle mass (in kilograms) from baseline to week twelve measured with bioelectrical impedance analysis (BIA) Tanita MC-980MA
Time Frame
three months
Title
LDL Cholesterol
Description
Changes in LDL cholesterol measured by biochemical analyzer Cobass
Time Frame
three months
Title
Inflammation
Description
Changes in C-reactive protein levels measured by biochemical analyzer Cobass
Time Frame
three months
Title
Glucose levels
Description
Changes in glucose levels measured by biochemical analyzer Cobass
Time Frame
three months
Title
Resting metabolic rate
Description
Changes in resting metabolic rate measured by (MedGem® Microlife, Medical Home Solutions, Inc., Golden, CO)
Time Frame
three months
Title
ultrasound scan of abdomen
Description
ultrasound scan of abdomen measured by Resona 7 Mindray
Time Frame
three months
Title
ultrasound scan of carotid arteries
Description
ultrasound scan of carotid arteries measured by Resona 7 Mindray
Time Frame
three months
Title
Antioxidative potential
Description
Antioxidative potential will be determined with DPPH radical measurement.
Time Frame
three months
Title
Blood Pressure
Description
Changes in systolic blood pressure measured by blood pressure device (Omron M3)
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University of Primorska, Faculty of Health Sciences
City
Izola
ZIP/Postal Code
6310
Country
Slovenia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34550357
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.
Results Reference
background
PubMed Identifier
35443107
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.
Results Reference
background
PubMed Identifier
33498955
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.
Results Reference
background
PubMed Identifier
36034217
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.
Results Reference
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Clinical Trials of Effects of Time Restricted Eating on Health Parameters in Adults

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