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

Not Applicable

Not yet recruiting

• Conditions: Overweight and Obesity; Time Restricted Eating; Metabolic Syndrome
• Interventions: Behavioral: Early time-restricted eating (eTRE); Behavioral: Late time-restricted eating (lTRE)

• Registration Number: NCT06018415
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-13
• Study First Submitted QC: 2023-08-29
• Study First Posted: 2023-08-30
• Study Start: 2023-09
• Last Update Submitted: 2023-09-04
• Last Update Posted: 2023-09-07
• Primary Completion: 2025-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 medications for elevated TG is an alternate indicator) ≥ 150 mg/dL (1.7 mmol/L).
   3. 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.
   4. Elevated blood pressure (use of hypoglycemic medications 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early time-restricted eating (eTRE)	Early time-restricted eating (eTRE)	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
Late time-restricted eating (lTRE)	Late time-restricted eating (lTRE)	The lTRE group is instructed toconsume all calories from 11 AM to 7 PM each day and fast from 7 PM to 11 PM

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
Changes in body composition (body muscle mass)	0-week; 6-week and 12-week	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.
Changes in glycemic control, haemoglobin A1c (HbA1c)	0-week; 6-week and 12-week	HbA1c is measured on an automatic HbA1c analyzer (TOSOH BIOSCIENCE, Inc.; HLC-723G8) to the nearest 0.1%.
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 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 body composition ( body fat mass)	0-week; 6-week and 12-week	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.
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.