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

NCT06018415 | Completed

• 1 other identifier: No.XJTU1AF2023LSK-398
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Time Restricted Eating; Metabolic Syndrome; Overweight and Obesity

Outcome Measures

Primary Outcomes (2)

• 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.

  0-week; 6-week and 12-week

• 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.

  0-week; 6-week and 12-week

Secondary Outcomes (7)

• Changes in body composition ( body fat mass)

  0-week and 12-week

• Changes in body composition (body muscle mass)

  0-week and 12-week

• Changes in glycemic control

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

• Changes in hemoglobin A1c (HbA1c)

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

• 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

Study Arms (2)

Early time-restricted eating (eTRE)

EXPERIMENTAL

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)

Late time-restricted eating (lTRE)

EXPERIMENTAL

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

Early time-restricted eating (eTRE) BEHAVIORAL

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

Early time-restricted eating (eTRE)

Late time-restricted eating (lTRE) BEHAVIORAL

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

Late time-restricted eating (lTRE)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

Metabolic Syndrome; Overweight; Obesity; Intermittent Fasting

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fasting; Feeding Behavior; Behavior

Study Officials

• Bingyin Shi

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2023
• First Posted: August 30, 2023
• Study Start: May 7, 2024
• Primary Completion: October 16, 2024
• Study Completion: October 16, 2024
• Last Updated: December 22, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)