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Completed

NCT Number: NCT06018415

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 lipid-lowering medication is an alternate indicator) ≥ 150 mg/dL (1.7 mmol/L).
  • 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.
  • Elevated blood pressure (use of antihypertensive medication 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.

Treatment and study plan

Early Time-Restricted Eating (eTRE)

Behavioral

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

Late time-restricted eating (lTRE)

Behavioral

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

Primary outcomes

  1. Changes in body weight

    Time frame: 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.

  2. Changes in abdominal fat area

    Time frame: 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 outcomes

  1. Changes in body composition ( body fat mass)

    Time frame: 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)

  2. Changes in body composition (body muscle mass)

    Time frame: 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)

  3. Changes in glycemic control

    Time frame: 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;

  4. Changes in hemoglobin A1c (HbA1c)

    Time frame: 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%.

  5. Changes in total cholesterol, triglyceride (TG), high-density lipoprotein cholesterol (HDL-c), and low-density lipoprotein cholesterol (LDL-c)

    Time frame: 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.

  6. Changes in uric acid (UA)

    Time frame: 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.

  7. Changes in blood pressure.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 30, 2023
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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