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

Primary Purpose

Metabolic Syndrome, Overweight and Obesity, Time Restricted Eating

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Early time-restricted eating (eTRE)
Late time-restricted eating (lTRE)
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Early time-restricted eating (eTRE)

    Late time-restricted eating (lTRE)

    Arm 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

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

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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%.
    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.
    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.
    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.

    Full Information

    First Posted
    August 13, 2023
    Last Updated
    September 4, 2023
    Sponsor
    First Affiliated Hospital Xi'an Jiaotong University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06018415
    Brief Title
    Effects of Early and Late Time-restricted Eating on Overweight Adults With Metabolic Syndrome
    Official Title
    Effects of Early and Late Time-restricted Eating on Overweight Adults With Metabolic Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    September 2025 (Anticipated)
    Study Completion Date
    September 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    First Affiliated Hospital Xi'an Jiaotong University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Syndrome, Overweight and Obesity, Time Restricted Eating

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Early time-restricted eating (eTRE)
    Arm Type
    Experimental
    Arm 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
    Arm Title
    Late time-restricted eating (lTRE)
    Arm Type
    Experimental
    Arm 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
    Intervention Type
    Behavioral
    Intervention Name(s)
    Early time-restricted eating (eTRE)
    Intervention Description
    The eTRE group is instructed to consume all calories in early 8h eating window,
    Intervention Type
    Behavioral
    Intervention Name(s)
    Late time-restricted eating (lTRE)
    Intervention Description
    The lTRE group is instructed to consume all calories in late 8h eating window.
    Primary Outcome Measure Information:
    Title
    Changes in body weight
    Description
    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.
    Time Frame
    0-week; 6-week and 12-week
    Title
    Changes in abdominal fat area
    Description
    Abdominal fat area is measured using bioelectrical impedance analysis (OMRON MEDICAL Beijing Co., Ltd. DUALSCAN, HDS-2000) to the nearest 1 cm2.
    Time Frame
    0-week; 6-week and 12-week
    Secondary Outcome Measure Information:
    Title
    Changes in body composition ( body fat mass)
    Description
    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.
    Time Frame
    0-week; 6-week and 12-week
    Title
    Changes in body composition (body muscle mass)
    Description
    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.
    Time Frame
    0-week; 6-week and 12-week
    Title
    Changes in glycemic control, haemoglobin A1c (HbA1c)
    Description
    HbA1c is measured on an automatic HbA1c analyzer (TOSOH BIOSCIENCE, Inc.; HLC-723G8) to the nearest 0.1%.
    Time Frame
    0-week; 6-week and 12-week
    Title
    Changes in total cholesterol, triglyceride (TG), high-density lipoprotein cholesterol (HDL-c), and low-density lipoprotein cholesterol (LDL-c)
    Description
    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.
    Time Frame
    0-week; 6-week and 12-week
    Title
    Changes in uric acid (UA)
    Description
    UA is measured on an automatic biochemistry analyzer (HITACHI, Inc.; LAbOSPECT, 008AS) using standard reagents to the nearest 1 µmol/L.
    Time Frame
    0-week; 6-week and 12-week
    Title
    Changes in blood pressure.
    Description
    Blood pressure is measured in triplicate using a digital automatic blood pressure (Omron HBP-9020, Kyoto, Japan) to the nearest 1 mmHg.
    Time Frame
    0-week; 6-week and 12-week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 medications for elevated TG is an alternate indicator) ≥ 150 mg/dL (1.7 mmol/L). 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. Elevated blood pressure (use of hypoglycemic medications 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bingyin Shi
    Phone
    0086-13630215630
    Email
    sby19590504@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bingyin Shi
    Organizational Affiliation
    First Affiliated Hospital Xi'an Jiaotong University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    There is no plan to make individual participant data (IPD) available to other researchers.

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

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