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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06018415
• Other study ID #: No.XJTU1AF2023LSK-398
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: September 2026

Study information

• Verified date: August 2023
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Bingyin Shi
• Phone: 0086-13630215630
• Email: sby19590504[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 medications for elevated TG is an alternate indicator) = 150 mg/dL (1.7 mmol/L).

3. Reduced high-density lipoprotein cholesterol (HDL-c) (use of medications for reduced HDL-c 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 hypoglycemic medications 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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Early time-restricted eating (eTRE)
The eTRE group is instructed to consume all calories in early 8h eating window,
• Late time-restricted eating (lTRE)
The lTRE group is instructed to consume all calories in late 8h eating window.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Changes in body composition ( body fat mass)	Body composition (body fat mass ) is measured using the direct segmental multifrequency bioelectrical impedance analysis method DSM-BIA (InBody H20) to the nearest 0.1 kg.	0-week; 6-week and 12-week
Secondary	Changes in body composition (body muscle mass)	Body composition ( body muscle mass) is measured using the direct segmental multifrequency bioelectrical impedance analysis method DSM-BIA (InBody H20) to the nearest 0.1 kg.	0-week; 6-week and 12-week
Secondary	Changes in glycemic control, haemoglobin A1c (HbA1c)	HbA1c is measured on an automatic HbA1c analyzer (TOSOH BIOSCIENCE, Inc.; HLC-723G8) to the nearest 0.1%.	0-week; 6-week and 12-week
Secondary	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.	0-week; 6-week and 12-week
Secondary	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.	0-week; 6-week and 12-week
Secondary	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.	0-week; 6-week and 12-week