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

Xi'an Jiaotong University

Status: Completed

Conditions: Time Restricted Eating; Overweight and Obesity; Metabolic Syndrome

Treatments: Behavioral: Early time-restricted eating (eTRE); Behavioral: Late time-restricted eating (lTRE)

Study type: Interventional

Funder types: Other

Identifiers

NCT06018415

No.XJTU1AF2023LSK-398

Details and patient eligibility

About

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

Enrollment: 103 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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103 participants in 2 patient groups

Early time-restricted eating (eTRE)

Experimental group

Description:

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

Treatment:

Behavioral: Early time-restricted eating (eTRE)

Late time-restricted eating (lTRE)

Experimental group

Description:

The lTRE group is instructed toconsume all calories from 11 AM to 7 PM each day and fast from 7 PM to 11 PM

Treatment:

Behavioral: Late time-restricted eating (lTRE)