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Obesity; Impaired Glucose Regulation; Prediabetes; Type 2 Diabetes MellitusTRE-SFR-EXNCT07726615

Time-Restricted Eating and Staple Food Reduction Combined With App-Supported Exercise for Weight and Glycemic Control

A study testing App-Supported Exercise Intervention, Staple Food Reduction and Early Time-Restricted Eating in people with Obesity; Impaired Glucose Regulation; Prediabetes; Type 2 Diabetes Mellitus, run by Peking University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This multicenter, three-arm randomized controlled trial will evaluate the effects of early time-restricted eating and staple food reduction, each combined with an app-supported exercise intervention, on body weight and glycemic control among adults with obesity and abnormal glucose metabolism. Read more about this study

Who is it for?
Ages 18 to 50 years
What is being tested?
App-Supported Exercise Intervention, Staple Food Reduction and Early Time-Restricted Eating
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
No sites listed yet
Study dates
Jul 2026to Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age 18 to 50 years, all sexes.
  • Body mass index (BMI) >=28 kg/m2.
  • Willing and able to comply with study procedures and provide written informed consent.
  • Resident living near a participating study site and able to complete scheduled visits.
  • No habitual time-restricted eating or other fasting regimen, such as alternate-day fasting or fasting-mimicking diet.
  • Abnormal glucose metabolism or diabetes, defined as fasting plasma glucose >5.6 mmol/L or HbA1c >5.7%.

Who cannot join

  • Secondary obesity, such as hypothyroidism or Cushing syndrome.
  • Use of weight-loss medication within 90 days before screening, or body weight change >5 kg within 90 days before screening.
  • Pregnant, lactating, or planning pregnancy during the study period.
  • Severe cardiac, hepatic, or renal dysfunction.
  • Severe psychiatric disease or cognitive impairment that prevents cooperation with the study.
  • Contraindication to exercise, such as severe osteoarthritis.
Show all 10Show fewer
  • Unable or unwilling to follow the study diet and exercise intervention.
  • Long-term use of medications that may significantly affect body weight.
  • Active malignancy in any organ system.
  • Any other condition that, in the investigator's judgment, may affect efficacy or safety evaluation or make the participant unsuitable for the study.

About this study

Official title: A Multicenter Randomized Controlled Trial of Time-Restricted Eating, Staple Food Reduction, and App-Supported Exercise for Weight Loss and Glycemic Improvement in Adults With Obesity and Abnormal Glucose Metabolism

This multicenter, three-arm randomized controlled trial will evaluate the effects of early time-restricted eating and staple food reduction, each combined with an app-supported exercise intervention, on body weight and glycemic control among adults with obesity and abnormal glucose metabolism. A total of 300 participants aged 18 to 50 years with BMI >=28 kg/m2 and impaired glucose regulation or diabetes will be enrolled at five centers in China and randomized 1:1:1 to app-supported exercise alone, staple food reduction plus app-supported exercise, or early time-restricted eating plus app-supported exercise. The intervention lasts 12 weeks, followed by a 12-week post-intervention follow-up.

Read the detailed description

All groups will use the Xiangdong Health app for exercise prescriptions, self-monitoring, and behavioral feedback. The staple food reduction group will reduce staple food intake by approximately one half at three meals without restriction of eating time. The early time-restricted eating group will consume food only between 07:00 and 15:00, with water allowed outside the eating window, without prescribed restriction of total daily energy intake. Outcomes will be measured at baseline, week 12, and week 24, including body weight, glycemic indices, continuous glucose monitoring metrics, body composition, blood pressure, blood biochemistry, urine tests, stool microbiome, dietary recall, physical activity, sleep, appetite, psychological measures, adherence, and adverse events.

Being tested
App-Supported Exercise Intervention, Staple Food Reduction, Early Time-Restricted Eating
Keywords
time-restricted eating; staple food reduction; app-supported exercise; obesity; abnormal glucose metabolism; continuous glucose monitoring
Medical subject headings
Obesity, Prediabetic State, Diabetes Mellitus, Type 2, Intermittent Fasting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • App-Supported Exercise InterventionBehavioural

    Participants receive individualized exercise prescriptions, self-monitoring, and behavioral feedback through the Xiangdong Health app for 12 weeks. The exercise program includes progressive aerobic exercise, resistance training, flexibility training, and balance training.

  • Staple Food ReductionBehavioural

    Participants reduce staple food intake by approximately one half at three meals without restriction of eating time. This dietary strategy is combined with the same app-supported exercise intervention.

  • Early Time-Restricted EatingBehavioural

    Participants consume food only from 07:00 to 15:00 each day, with water allowed outside the eating window. Total daily energy intake is not prescribed, and participants are advised to follow the Chinese Dietary Guidelines. This dietary strategy is combined with the same app-supported exercise intervention.

Study groups in NCT07726615
Study groupRoleWhat they receive
App-Supported ExerciseActive comparatorParticipants receive exercise prescriptions, self-monitoring, and behavioral feedback through the Xiangdong Health app for 12 weeks. The program includes progressive aerobic exercise, resistance training, flexibility training, and balance training.
Receives: Behavioral: App-Supported Exercise Intervention
Staple Food Reduction Plus App-Supported ExerciseExperimentalParticipants reduce staple food intake by approximately one half at three meals without restriction of eating time and receive the same app-supported exercise intervention for 12 weeks.
Receives: Behavioral: App-Supported Exercise Intervention; Behavioral: Staple Food Reduction
Early Time-Restricted Eating Plus App-Supported ExerciseExperimentalParticipants consume food only from 07:00 to 15:00 each day, with water allowed outside the eating window, without prescribed restriction of total daily energy intake, and receive the same app-supported exercise intervention for 12 weeks.
Receives: Behavioral: App-Supported Exercise Intervention; Behavioral: Early Time-Restricted Eating

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in body weight from baseline to week 12

    Body weight will be measured using a calibrated scale. The primary analysis will compare absolute change in body weight from baseline to week 12 among the three randomized groups.

    Measured: Baseline and week 12

  2. Change in CGM-derived glucose exposure and time in range from baseline to week 12

    Continuous glucose monitoring (CGM) metrics will include glucose area under the curve and time in range (TIR), defined as the percentage of valid CGM readings between 3.9 and 10.0 mmol/L. Changes from baseline to week 12 will be compared among the three randomized groups.

    Measured: Baseline and week 12

Secondary outcomes (28)
  1. Change in BMI from baseline to week 12 and week 24

    Calculated as weight in kg divided by height in meters squared (kg/m²). Changes will be compared among the three randomized groups.

    Measured: Baseline, week 12, and week 24

  2. Change in body fat mass from baseline to week 12 and week 24

    Change in body fat mass (measured in kilograms, kg) from baseline to week 12 and week 24, assessed by bioelectrical impedance analysis.

    Measured: Baseline, week 12, and week 24

  3. Change in fasting plasma glucose from baseline to week 12 and week 24

    Fasting plasma glucose will be measured in millimoles per liter (mmol/L). Changes will be compared among the three randomized groups.

    Measured: Baseline, week 12, and week 24

  4. Change in systolic blood pressure from baseline to week 12 and week 24

    Systolic blood pressure will be measured in millimeters of mercury (mmHg). Changes will be compared among the three randomized groups.

    Measured: Baseline, week 12, and week 24

  5. Change in CGM-derived mean glucose from baseline to week 12 and week 24

    Mean glucose will be calculated from valid CGM readings and reported in millimoles per liter (mmol/L). Changes will be compared among the three randomized groups.

    Measured: Baseline, week 12, and week 24

  6. Change in questionnaire-based behavioral and patient-reported measures from baseline to week 12 and week 24

    Questionnaire-based measures include dietary intake, physical activity, sleep, psychological status, appetite, and intervention adherence.

    Measured: Baseline, week 12, and week 24

  7. Adverse events and serious adverse events

    Adverse events and serious adverse events will be collected throughout the intervention and follow-up period and summarized by randomized group.

    Measured: From baseline through week 24

  8. Change in Waist circumference from baseline to week 12 and week 24

    Measured in centimeters (cm). Changes will be compared among the three randomized groups.

    Measured: Baseline, week 12, and week 24

  9. Change in Hip circumference from baseline to week 12 and week 24

    Measured in centimeters (cm). Changes will be compared among the three randomized groups.

    Measured: Baseline, week 12, and week 24

  10. Change in Waist-to-hip ratio (WHR) from baseline to week 12 and week 24

    Calculated as a unitless ratio. Changes will be compared among the three randomized groups.

    Measured: Baseline, week 12, and week 24

  11. Change in body fat percentage from baseline to week 12 and week 24

    Change in body fat percentage (measured in %) from baseline to week 12 and week 24, assessed by bioelectrical impedance analysis.

    Measured: Baseline, week 12, and week 24

  12. Change in skeletal muscle mass from baseline to week 12 and week 24

    Change in skeletal muscle mass (measured in kilograms, kg) from baseline to week 12 and week 24, assessed by bioelectrical impedance analysis.

    Measured: Baseline, week 12, and week 24

  13. Change in glycated hemoglobin (HbA1c) from baseline to week 12 and week 24

    Glycated hemoglobin (HbA1c) will be measured as a percentage. Changes will be compared among the three randomized groups.

    Measured: Baseline, week 12, and week 24

  14. Change in fasting plasma insulin from baseline to week 12 and week 24

    Fasting plasma insulin will be measured in microunits per milliliter (µIU/mL). Changes will be compared among the three randomized groups.

    Measured: Baseline, week 12, and week 24

  15. Change in homeostatic model assessment of insulin resistance from baseline to week 12 and week 24

    Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) will be calculated from fasting plasma glucose and fasting plasma insulin and reported as a unitless index. Changes will be compared among the three randomized groups.

    Measured: Baseline, week 12, and week 24

  16. Change in diastolic blood pressure from baseline to week 12 and week 24

    Diastolic blood pressure will be measured in millimeters of mercury (mmHg). Changes will be compared among the three randomized groups.

    Measured: Baseline, week 12, and week 24

  17. Change in heart rate from baseline to week 12 and week 24

    Heart rate will be measured in beats per minute (bpm). Changes will be compared among the three randomized groups.

    Measured: Baseline, week 12, and week 24

  18. Change in total cholesterol from baseline to week 12 and week 24

    Fasting serum total cholesterol will be measured in millimoles per liter (mmol/L). Changes will be compared among the three randomized groups.

    Measured: Baseline, week 12, and week 24

  19. Change in triglycerides from baseline to week 12 and week 24

    Fasting serum triglycerides will be measured in millimoles per liter (mmol/L). Changes will be compared among the three randomized groups.

    Measured: Baseline, week 12, and week 24

  20. Change in low-density lipoprotein cholesterol from baseline to week 12 and week 24

    Fasting serum low-density lipoprotein cholesterol (LDL-C) will be measured in millimoles per liter (mmol/L). Changes will be compared among the three randomized groups.

    Measured: Baseline, week 12, and week 24

  21. Change in high-density lipoprotein cholesterol from baseline to week 12 and week 24

    Fasting serum high-density lipoprotein cholesterol (HDL-C) will be measured in millimoles per liter (mmol/L). Changes will be compared among the three randomized groups.

    Measured: Baseline, week 12, and week 24

  22. Change in alanine aminotransferase from baseline to week 12 and week 24

    Serum alanine aminotransferase (ALT) will be measured in units per liter (U/L). Changes will be compared among the three randomized groups.

    Measured: Baseline, week 12, and week 24

  23. Change in aspartate aminotransferase from baseline to week 12 and week 24

    Serum aspartate aminotransferase (AST) will be measured in units per liter (U/L). Changes will be compared among the three randomized groups.

    Measured: Baseline, week 12, and week 24

  24. Change in serum creatinine from baseline to week 12 and week 24

    Serum creatinine will be measured in micromoles per liter (µmol/L). Changes will be compared among the three randomized groups.

    Measured: Baseline, week 12, and week 24

  25. Change in serum uric acid from baseline to week 12 and week 24

    Serum uric acid will be measured in micromoles per liter (µmol/L). Changes will be compared among the three randomized groups.

    Measured: Baseline, week 12, and week 24

  26. Change in CGM-derived time above range from baseline to week 12 and week 24

    Time above range (TAR) will be calculated as the percentage of valid CGM readings above 10.0 mmol/L. Changes will be compared among the three randomized groups.

    Measured: Baseline, week 12, and week 24

  27. Change in CGM-derived time below range from baseline to week 12 and week 24

    Time below range (TBR) will be calculated as the percentage of valid CGM readings below 3.9 mmol/L. Changes will be compared among the three randomized groups.

    Measured: Baseline, week 12, and week 24

  28. Change in CGM-derived glucose coefficient of variation from baseline to week 12 and week 24

    The glucose coefficient of variation (CV) will be calculated from valid CGM readings and reported as a percentage. Changes will be compared among the three randomized groups.

    Measured: Baseline, week 12, and week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2026
  2. Study startJul 2026 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

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
Model description
Participants will be randomized in a 1:1:1 ratio using a computer-generated sequence, stratified by study center, with allocation concealment using sequentially numbered opaque sealed envelopes or a central randomization process.
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07726615
Sponsor's protocol ID
IRB00001052-26093
Acronym
TRE-SFR-EX
Status last verified
Jul 2026
First submitted
13 Jul 2026
Last updated
24 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared publicly because the study includes sensitive health information and biological sample data. De-identified aggregate results will be reported in scientific publications.

Questions about this trial

What is this clinical trial studying?

A study testing App-Supported Exercise Intervention, Staple Food Reduction and Early Time-Restricted Eating in people with Obesity; Impaired Glucose Regulation; Prediabetes; Type 2 Diabetes Mellitus, run by Peking University.

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 6 inclusion and 10 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: opening soon, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

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?

Change in body weight from baseline to week 12 (time frame: Baseline and week 12). 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 24 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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