Metabolic Syndrome, Overweight and Obesity, Time Restricted Eating
Conditions
Brief summary
Investigators aim to compare the effects of early and late time-restricted feeding on overweight adults with metabolic syndrome
Interventions
BEHAVIORALEarly time-restricted eating (eTRE)
The eTRE group is instructed to consume all calories in early 8h eating window,
BEHAVIORALLate time-restricted eating (lTRE)
The lTRE group is instructed to consume all calories in late 8h eating window.
Sponsors
First Affiliated Hospital Xi'an Jiaotong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age from 18 to 65 years 2. Body mass index (BMI): 24.0-40.0 kg/m2 3. Diagnosed with metabolic syndrome (i.e., more than 3 abnormal findings out of 5): 1. Waist circumference ≥ 90 cm (men) or ≥ 80 cm (women). 2. Elevated triglyceride (TG) (use of lipid-lowering medication is an alternate indicator) ≥ 150 mg/dL (1.7 mmol/L). 3. Reduced high-density lipoprotein cholesterol (HDL-c) (use of lipid-lowering medication is an alternate indicator) \< 40 mg/dL (1.0 mmol/L) in males \< 50 mg/dL (1.3 mmol/L) in females. 4. Elevated blood pressure (use of antihypertensive medication is an alternate indicator). Systolic blood pressure (SBP) ≥ 130 and/or diastolic blood pressure (DBP) ≥ 85 mmHg. 5. Elevated fasting blood glucose (FBG) (used of hypoglycemic medications is an alternate indicator) ≥ 100 mg/dL (5.6 mmol/L).
Exclusion criteria
1. Unstable weight (change \> 10% current body weight) for 3 months prior to the study 2. Pregnant or breast-feeding 3. Night shift workers 4. History of major diseases or related diseases, such as cancer, inflammatory disease, chronic obstructive pulmonary disease and major adverse cardiovascular event 5. Active viral hepatitis, acquired immune deficiency syndrome, syphilis and other sexually transmitted diseases, tuberculosis and other infectious diseases 6. Being treated with antibiotics or corticosteroids 7. Current participate in other weight-management program, current on a prescribed diet for special disease or current on any drugs that effect appetite 8. The researcher deemed it inappropriate to participate in the experimenter.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in body weight | 0-week; 6-week and 12-week | 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. |
| Changes in abdominal fat area | 0-week; 6-week and 12-week | Abdominal fat area is measured using bioelectrical impedance analysis (OMRON MEDICAL Beijing Co., Ltd. DUALSCAN, HDS-2000) to the nearest 1 cm2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in glycemic control | 0-week; 6-week and 12-week (glucose and insulin)0-week and 12-week (HbA1c) | Plasma glucose is measured on an automatic biochemistry analyzer (HITACHI, Inc.; LAbOSPECT, 008AS) using standard reagents to the nearest 0.01 mmol/L; Serum insulin is measured by a magnetic particle chemiluminescence immunoassay (Kaeser 6600, Guangzhou Kangrun Co., Ltd., China) to the nearest 0.01 μIU/mL; |
| Changes in hemoglobin A1c (HbA1c) | 0-week; 6-week and 12-week (glucose and insulin)0-week and 12-week (HbA1c) | HbA1c is measured on an automatic HbA1c analyzer (TOSOH BIOSCIENCE, Inc.; HLC-723G8) to the nearest 0.1%. |
| Changes in body composition ( body fat mass) | 0-week and 12-week | Body composition (body fat mass ) is measured using the dual-energy X-ray absorptiometry (DXA, Hologic Serie horzion-wi QDR., Bedford, MA, USA) |
| Changes in uric acid (UA) | 0-week; 6-week and 12-week | UA is measured on an automatic biochemistry analyzer (HITACHI, Inc.; LAbOSPECT, 008AS) using standard reagents to the nearest 1 µmol/L. |
| Changes in blood pressure. | 0-week; 6-week and 12-week | Blood pressure is measured in triplicate using a digital automatic blood pressure (Omron HBP-9020, Kyoto, Japan) to the nearest 1 mmHg. |
| Changes in total cholesterol, triglyceride (TG), high-density lipoprotein cholesterol (HDL-c), and low-density lipoprotein cholesterol (LDL-c) | 0-week; 6-week and 12-week | 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. |
| Changes in body composition (body muscle mass) | 0-week and 12-week | Body composition ( body muscle mass) is measured using the dual-energy X-ray absorptiometry (DXA, Hologic Serie horzion-wi QDR., Bedford, MA, USA) |
Countries
China
Outcome results
None listed