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

Sponsor
First Affiliated Hospital Xi'an Jiaotong University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06018415
Collaborator
(none)
100
2
36

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Early time-restricted eating (eTRE)
  • Behavioral: Late time-restricted eating (lTRE)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Early and Late Time-restricted Eating on Overweight Adults With Metabolic Syndrome
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2025
Anticipated Study Completion Date :
Sep 1, 2026

Arms and Interventions

Arm Intervention/Treatment
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)
The eTRE group is instructed to consume all calories in early 8h eating window,

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

Outcome Measures

Primary Outcome Measures

  1. Changes in body weight [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 [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 Outcome Measures

  1. Changes in body composition ( body fat mass) [0-week; 6-week and 12-week]

    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.

  2. Changes in body composition (body muscle mass) [0-week; 6-week and 12-week]

    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.

  3. Changes in glycemic control, haemoglobin A1c (HbA1c) [0-week; 6-week and 12-week]

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

  4. 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]

    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.

  5. Changes in uric acid (UA) [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.

  6. Changes in blood pressure. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
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):

  4. Waist circumference ≥ 90 cm (men) or ≥ 80 cm (women).

  5. Elevated triglyceride (TG) (use of medications for elevated TG is an alternate indicator) ≥ 150 mg/dL (1.7 mmol/L).

  6. 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.

  7. Elevated blood pressure (use of hypoglycemic medications is an alternate indicator). Systolic blood pressure (SBP) ≥ 130 and/or diastolic blood pressure (DBP) ≥ 85 mmHg.

  8. 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Study Chair: Bingyin Shi, First Affiliated Hospital Xi'an Jiaotong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier:
NCT06018415
Other Study ID Numbers:
  • No.XJTU1AF2023LSK-398
First Posted:
Aug 30, 2023
Last Update Posted:
Sep 7, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 7, 2023