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

NCT ID: NCT06018415

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-07
• Study Completion Date: 2024-10-16

Brief Summary

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

Conditions

Metabolic Syndrome; Overweight and Obesity; Time Restricted Eating

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Early time-restricted eating (eTRE)

Intervention Type: BEHAVIORAL

The eTRE group is instructed to consume all calories in early 8h eating window,

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

Group Type: EXPERIMENTAL

Late time-restricted eating (lTRE)

Intervention Type: BEHAVIORAL

The lTRE group is instructed to consume all calories in late 8h eating window.

Interventions

Early time-restricted eating (eTRE)

The eTRE group is instructed to consume all calories in early 8h eating window,

Intervention Type: BEHAVIORAL

Late time-restricted eating (lTRE)

The lTRE group is instructed to consume all calories in late 8h eating window.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bingyin Shi

Role: STUDY_CHAIR

First Affiliated Hospital Xi'an Jiaotong University

Locations

First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

No.XJTU1AF2023LSK-398

Identifier Type: -

Identifier Source: org_study_id