Effects of Early and Late Time-restricted Eating on Overweight Adults With Metabolic Syndrome

Study Overview
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Brief Summary
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Investigators aim to compare the effects of early and late time-restricted feeding on overweight adults with metabolic syndrome

Official Title
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Effects of Early and Late Time-restricted Eating on Overweight Adults With Metabolic Syndrome

Conditions
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Metabolic Syndrome, Overweight and Obesity, Time Restricted Eating

Intervention / Treatment
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* Behavioral: Early time-restricted eating (eTRE)
* Behavioral: Late time-restricted eating (lTRE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from 18 to 65 years Body mass index (BMI): 24.0-40.0 kg/m2 Diagnosed with metabolic syndrome (i.e., more than 3 abnormal findings out of 5): Waist circumference ≥ 90 cm (men) or ≥ 80 cm (women). Elevated triglyceride (TG) (use of medications for elevated TG is an alternate indicator) ≥ 150 mg/dL (1.7 mmol/L). Reduced high-density lipoprotein cholesterol (HDL-c) (use of medications for reduced HDL-c is an alternate indicator) < 40 mg/dL (1.0 mmol/L) in males < 50 mg/dL (1.3 mmol/L) in females. Elevated blood pressure (use of hypoglycemic medications is an alternate indicator). Systolic blood pressure (SBP) ≥ 130 and/or diastolic blood pressure (DBP) ≥ 85 mmHg. Elevated fasting blood glucose (FBG) (used of hypoglycemic medications is an alternate indicator) ≥ 100 mg/dL (5.6 mmol/L). Exclusion Criteria: Unstable weight (change > 10% current body weight) for 3 months prior to the study Pregnant or breast-feeding Night shift workers History of major diseases or related diseases, such as cancer, inflammatory disease, chronic obstructive pulmonary disease and major adverse cardiovascular event Active viral hepatitis, acquired immune deficiency syndrome, syphilis and other sexually transmitted diseases, tuberculosis and other infectious diseases Being treated with antibiotics or corticosteroids Current participate in other weight-management program, current on a prescribed diet for special disease or current on any drugs that effect appetite The researcher deemed it inappropriate to participate in the experimenter.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early time-restricted eating (eTRE)<br>The eTRE group is instructed to consume all calories from 7 AM to 3 PM each day and fast from 3 PM to 7 AM | Behavioral: Early time-restricted eating (eTRE)<br>* The eTRE group is instructed to consume all calories in early 8h eating window,<br>|
| Experimental: Late time-restricted eating (lTRE)<br>The lTRE group is instructed toconsume all calories from 11 AM to 7 PM each day and fast from 7 PM to 11 PM | Behavioral: Late time-restricted eating (lTRE)<br>* The lTRE group is instructed to consume all calories in late 8h eating window.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body weight | Body weight is assessed at the research center with the participants without shoes and in light clothing using a digital scale (OMRON MEDICAL Beijing Co., Ltd. HNH-318) to the nearest 0.1 kg. | 0-week; 6-week and 12-week | 
| Changes in abdominal fat area | Abdominal fat area is measured using bioelectrical impedance analysis (OMRON MEDICAL Beijing Co., Ltd. DUALSCAN, HDS-2000) to the nearest 1 cm2. | 0-week; 6-week and 12-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body composition ( body fat mass) | Body composition (body fat mass ) is measured using the direct segmental multifrequency bioelectrical impedance analysis method DSM-BIA (InBody H20) to the nearest 0.1 kg. | 0-week; 6-week and 12-week | 
| Changes in body composition (body muscle mass) | Body composition ( body muscle mass) is measured using the direct segmental multifrequency bioelectrical impedance analysis method DSM-BIA (InBody H20) to the nearest 0.1 kg. | 0-week; 6-week and 12-week | 
| Changes in glycemic control, haemoglobin A1c (HbA1c) | HbA1c is measured on an automatic HbA1c analyzer (TOSOH BIOSCIENCE, Inc.; HLC-723G8) to the nearest 0.1%. | 0-week; 6-week and 12-week | 
| Changes in total cholesterol, triglyceride (TG), high-density lipoprotein cholesterol (HDL-c), and low-density lipoprotein cholesterol (LDL-c) | Plasma lipids of total cholesterol, TG, HDL-c, and LDL-c are measured on an automatic biochemistry analyzer (HITACHI, Inc.; LAbOSPECT, 008AS) using standard reagents to the nearest 0.01 mmol/L. | 0-week; 6-week and 12-week | 
| Changes in uric acid (UA) | UA is measured on an automatic biochemistry analyzer (HITACHI, Inc.; LAbOSPECT, 008AS) using standard reagents to the nearest 1 µmol/L. | 0-week; 6-week and 12-week | 
| Changes in blood pressure. | Blood pressure is measured in triplicate using a digital automatic blood pressure (Omron HBP-9020, Kyoto, Japan) to the nearest 1 mmHg. | 0-week; 6-week and 12-week |