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CompletedNCT06018415Updated Dec 22, 2025

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

An interventional study of Early time-restricted eating (eTRE) and Late time-restricted eating (lTRE) in Metabolic Syndrome, Overweight and Obesity and Time Restricted Eating, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-22.

Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
103
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Metabolic Syndrome
  • Overweight and Obesity
  • Time Restricted Eating
03

In context

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's enrollment of 103 is above the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
103 participants (actual)

Study arms

  • Experimental
    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

    Behavioral: Early time-restricted eating (eTRE)

  • Experimental
    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

    Behavioral: Late time-restricted eating (lTRE)

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 0-week; 6-week and 12-week

  2. 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.

    Time frame: 0-week; 6-week and 12-week

Secondary outcomes

  1. Changes in body composition ( body fat mass)

    Body composition (body fat mass ) is measured using the dual-energy X-ray absorptiometry (DXA, Hologic Serie horzion-wi QDR., Bedford, MA, USA)

    Time frame: 0-week and 12-week

  2. Changes in body composition (body muscle mass)

    Body composition ( body muscle mass) is measured using the dual-energy X-ray absorptiometry (DXA, Hologic Serie horzion-wi QDR., Bedford, MA, USA)

    Time frame: 0-week and 12-week

  3. Changes in glycemic control

    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;

    Time frame: 0-week; 6-week and 12-week (glucose and insulin)0-week and 12-week (HbA1c)

  4. Changes in hemoglobin A1c (HbA1c)

    HbA1c is measured on an automatic HbA1c analyzer (TOSOH BIOSCIENCE, Inc.; HLC-723G8) to the nearest 0.1%.

    Time frame: 0-week; 6-week and 12-week (glucose and insulin)0-week and 12-week (HbA1c)

  5. 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.

    Time frame: 0-week; 6-week and 12-week

  6. 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.

    Time frame: 0-week; 6-week and 12-week

  7. 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.

    Time frame: 0-week; 6-week and 12-week

07

Study locations

1 site
  • First Affiliated Hospital of Xi 'an Jiaotong University
    Xi'an, Shaanxi 710061, China
08

References and documents

Individual participant data

Plan to share: No — There is no plan to make individual participant data (IPD) available to other researchers.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06018415
Lead sponsor
First Affiliated Hospital Xi'an Jiaotong University
Responsible party
Sponsor
First posted
Aug 30, 2023
Start date
May 7, 2024
Primary completion
Oct 16, 2024
Completion
Oct 16, 2024
Last update
Dec 22, 2025

Study contacts

Bingyin Shi
study chair · First Affiliated Hospital Xi'an Jiaotong University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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