Metabolic SyndromeNCT06018415
Effects of Early and Late Time-restricted Eating on Overweight Adults With Metabolic Syndrome
A study testing Early time-restricted eating (eTRE) and Late time-restricted eating (lTRE) in people with Metabolic Syndrome and Overweight and Obesity, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Investigators aim to compare the effects of early and late time-restricted feeding on overweight adults with metabolic syndrome Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic Syndrome, Overweight and Obesity, Time Restricted Eating
- What is being tested?
- Early time-restricted eating (eTRE) and Late time-restricted eating (lTRE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteChina
- Study dates
- 7 May 2024to 16 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi, 710061
About this study
Investigators aim to compare the effects of early and late time-restricted feeding on overweight adults with metabolic syndrome
- Being tested
- Early time-restricted eating (eTRE), Late time-restricted eating (lTRE)
- Medical subject headings
- Metabolic Syndrome, Overweight, Obesity, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early time-restricted eating (eTRE)Behavioural
The eTRE group is instructed to consume all calories in early 8h eating window,
Late time-restricted eating (lTRE)Behavioural
The lTRE group is instructed to consume all calories in late 8h eating window.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Late time-restricted eating (lTRE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 0-week; 6-week and 12-week
Secondary outcomes (7)
Changes in body composition ( body fat mass)
Body composition (body fat mass ) is measured using the dual-energy X-ray absorptiometry (DXA, Hologic Serie horzion-wi QDR., Bedford, MA, USA)
Measured: 0-week and 12-week
Changes in body composition (body muscle mass)
Body composition ( body muscle mass) is measured using the dual-energy X-ray absorptiometry (DXA, Hologic Serie horzion-wi QDR., Bedford, MA, USA)
Measured: 0-week and 12-week
Changes in glycemic control
Plasma glucose is measured on an automatic biochemistry analyzer (HITACHI, Inc.; LAbOSPECT, 008AS) using standard reagents to the nearest 0.01 mmol/L; Serum insulin is measured by a magnetic particle chemiluminescence immunoassay (Kaeser 6600, Guangzhou Kangrun Co., Ltd., China) to the nearest 0.01 μIU/mL;
Measured: 0-week; 6-week and 12-week (glucose and insulin)0-week and 12-week (HbA1c)
Changes in hemoglobin A1c (HbA1c)
HbA1c is measured on an automatic HbA1c analyzer (TOSOH BIOSCIENCE, Inc.; HLC-723G8) to the nearest 0.1%.
Measured: 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)
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.
Measured: 0-week; 6-week and 12-week
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.
Measured: 0-week; 6-week and 12-week
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.
Measured: 0-week; 6-week and 12-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start7 May 2024
- Primary completion16 Oct 2024
- Study completion16 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bingyin Shi, Study chair, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018415
- Sponsor's protocol ID
- No.XJTU1AF2023LSK-398
- Status last verified
- Dec 2024
- First submitted
- 13 Aug 2023
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early and Late Time-restricted Eating on Overweight Adults With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT06018415
- Acronym / sponsor ID
- No.XJTU1AF2023LSK-398
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 7 May 2024 (actual)
- Primary completion
- 16 Oct 2024 (actual)
- Study completion
- 16 Oct 2024 (actual)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators aim to compare the effects of early and late time-restricted feeding on overweight adults with metabolic syndrome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early time-restricted eating (eTRE) | Experimental | Behavioral: 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 |
| Late time-restricted eating (lTRE) | Experimental | Behavioral: 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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):
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early time-restricted eating (eTRE)The eTRE group is instructed to consume all calories in early 8h eating window, | Behavioural | Early time-restricted eating (eTRE) |
| Late time-restricted eating (lTRE)The lTRE group is instructed to consume all calories in late 8h eating window. | Behavioural | Late time-restricted eating (lTRE) |
Primary outcome
Changes in body weight
Time frame: 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.
Changes in abdominal fat area
Time frame: 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.
7 secondary outcomes
Changes in body composition ( body fat mass)
Time frame: 0-week and 12-week
Changes in body composition (body muscle mass)
Time frame: 0-week and 12-week
Changes in glycemic control
Time frame: 0-week; 6-week and 12-week (glucose and insulin)0-week and 12-week (HbA1c)
Changes in hemoglobin A1c (HbA1c)
Time frame: 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)
Time frame: 0-week; 6-week and 12-week
Changes in uric acid (UA)
Time frame: 0-week; 6-week and 12-week
Changes in blood pressure.
Time frame: 0-week; 6-week and 12-week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bingyin Shi study chair
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early time-restricted eating (eTRE) and Late time-restricted eating (lTRE) in people with Metabolic Syndrome and Overweight and Obesity, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in body weight (time frame: 0-week; 6-week and 12-week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.