AzTrials
AzTrials

Overweight or Obese AdultsNCT07163455

Time-Restricted Eating for Weight-Loss Maintenance

A study testing Scheduled Weight Maintenance Nutrition Education and Time-Restricted Eating (10-Hour Window) in people with Overweight or Obese Adults, run by Harbin Medical University at 10 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Weight regain after intentional short-term weight loss is a common challenge. It often undermines the long-term benefits of obesity treatment. This study is a multi-center 2-arm randomized controlled trial across six regions in China, specifically targeting overweight or obese adults who have recently achieved a… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Overweight or Obese Adults
What is being tested?
Scheduled Weight Maintenance Nutrition Education and Time-Restricted Eating (10-Hour Window)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
10 sitesChina
Study dates
26 Jan 2026to Jul 2028
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants who meet all the following conditions will be included in the trial:
  • BMI ≥ 28.0 kg/m², or BMI between 24.0-27.9 kg/m² with at least one weight-related comorbidity.
  • Age: 18-65 years.
  • Weight Loss Plan: Willing to undergo a structured weight-loss program.

Who cannot join

  • Participants who meet any of the following conditions will be excluded from the trial:
  • Infectious Diseases: History of HIV/AIDS, active hepatitis B/C, or active tuberculosis.
  • Malignancy: History of any malignancy.
  • Organ Dysfunction:Severe hepatic impairment.Chronic kidney disease.
  • Cardiovascular/Cerebrovascular Events: History of angina, myocardial infarction, or stroke within the past 6 months.
  • Gastrointestinal Conditions:Severe gastrointestinal diseases (e.g., inflammatory bowel disease).Gastrointestinal surgery within the past 12 months.
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  • Endocrine Disorders:Cushing's syndrome, hypothyroidism, acromegaly, or hypothalamic obesity.
  • Medications: Use of drugs affecting weight/energy balance (e.g., antipsychotics, weight-loss medications) within the past 6 months.
  • Pregnancy/Lactation: Currently pregnant, planning pregnancy, or breastfeeding.
  • Compliance Issues: Inability to complete the study (due to health, immigration, or other reasons).
  • Informed Consent: Unwilling or unable to provide informed consent.
  • Weight Stability: >5% change in body weight within the past 6 months.
  • Individuals unable to use or operate a smartphone

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

China10 sites

  • The Fifth Medical Center of Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100071

  • Chengdu Seventh People's Hospital

    Chengdu, Sichuan, 610213

  • Army Medical Center of PLA

    Chongqing, Chongqing Municipality, 400010

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

  • Harbin Medical University

    Harbin, Heilongjiang, 150081

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150086

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266000

  • Shenzhen People's Hospital

    Shenzhen, Guangdong, 518020

  • Weifang People's Hospital

    Weifang, Shandong, 261041

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710004

Other trials in China

About this study

Official title: Time-Restricted Eating (10-Hour Window) for Weight-Loss Maintenance in Adults With Recent Intentional Weight Loss: A Multicenter, 12-Month Randomized Controlled Trial

Weight regain after intentional short-term weight loss is a common challenge. It often undermines the long-term benefits of obesity treatment. This study is a multi-center 2-arm randomized controlled trial across six regions in China, specifically targeting overweight or obese adults who have recently achieved a short-term weight reduction (≥5% of body weight). The trial will evaluate whether a 10-hour daily Time-Restricted Eating (TRE) regimen can more effectively prevent weight regain compared to standard weight maintenance counseling alone. Both the intervention and control groups will receive the same frequency and intensity of nutritional counseling for weight maintenance; the only difference is that the TRE group will be instructed to confine their daily eating to a self-selected 10-hour window, while the control group has no eating window restriction. In addition to the primary outcome of weight regain, the study will explore potential mechanisms underlying the effects of TRE and assess secondary outcomes including changes in body composition, metabolic health, and quality of life.

This study recruits participants from six distinct regions across Eastern, Western, Southern, Northern, and Central China to enhance national representativeness. The study is divided into two phases: the first phase is a 2-month weight loss run-in phase (the screening phase), during which participants will receive standardized lifestyle and diet guidance from trained dietitians. Those who achieve at least a 5% loss of initial body weight by the end of this phase-and maintain a stable weight for approximately three weeks-will proceed to the second phase. In the second phase, participants will be randomly assigned to one of two arms for a 12-month weight maintenance intervention. The Control Arm will receive periodic weight-management nutritional counseling without any eating time restriction, while the TRE Intervention Arm will receive the same guidance plus instructions to follow a daily 10-hour time-restricted eating schedule. This design ensures both groups receive equivalent dietary and lifestyle support, with TRE as the key differential strategy. Following the 12-month intervention phase, participants will be followed for an additional 12 months (without active intervention) to observe longer-term weight outcomes.

Data will be collected at multiple time points: baseline (before the weight loss phase), 2 months (end of the weight loss phase and prior to the start of the maintenance phase), 5 months, 8 months, 14 months (end of the weight maintenance phase), as well as 20 months and 26 months (during the post-intervention follow-up). Key outcomes include changes in body weight (to assess weight regain or maintenance), body composition, metabolic health indicators (e.g. blood glucose, lipids), and quality of life measures. To monitor dietary behaviors, participants will be asked to upload meal photos via a designated mobile application with automatic time-stamping, which will be used to assess eating timing and adherence to the prescribed eating window. Body weight will be measured once weekly using Bluetooth-enabled smart scales. To explore potential mechanisms of action, biospecimens (blood and stool) will be collected at baseline, 2 months, 8 months, and 14 months for analysis. In addition, Continuous Glucose Monitoring (CGM) will be performed in a randomly selected subsample of 200 participants (100 from each group) using a standardized device for 14 consecutive days at months 2, 8, and 14. These data will be used to evaluate glycemic stability and adherence to the assigned eating window. Real-time CGM readings will not be disclosed to participants and will not be used to guide individual-level interventions.

Being tested
Scheduled Weight Maintenance Nutrition Education, Time-Restricted Eating (10-Hour Window)
Medical subject headings
Overweight

What participants receive

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

  • Scheduled Weight Maintenance Nutrition EducationBehavioural

    Participants will receive a standardized 30-45 minute weight maintenance nutrition education session at the time of randomization, covering principles of balanced dietary intake, reduction of salt, oil, and added sugar, adequate hydration. Thereafter, monthly 15-minute follow-up sessions will be delivered by trained dietitians, matched in frequency and content to those provided in the intervention arm. No temporal restriction will be imposed on eating behaviors. Participants will document meal intake via a mobile application using photograph-based entries with automated time-stamping and will record body weight weekly using Bluetooth-enabled digital scales. To ensure data accuracy, quality control will include twice-monthly brief telephone interviews for unannounced 24-hour dietary recalls.

  • Time-Restricted Eating (10-Hour Window)Behavioural

    In addition to receiving the same frequency and content of standardized nutritional counseling as the control group, participants will be instructed to confine all caloric intake to a self-selected 10-hour daily eating window. Outside of this window, only non-caloric beverages (e.g., water, unsweetened tea, black coffee) are permitted. Up to one exception day per week is allowed, during which intake may fall outside the designated window but must still be recorded. Dietary intake will be logged through a mobile application utilizing meal photographs with automated time-stamping; body weight will be recorded weekly using Bluetooth-enabled digital scales. As with the control group, participants will receive twice-monthly unannounced 24-hour dietary recalls and phone interviews to verify dietary records and ensure data quality.

Study groups in NCT07163455
Study groupRoleWhat they receive
Scheduled Weight Maintenance Nutrition EducationActive comparatorParticipants will receive standardized nutritional counseling for weight maintenance without any restriction on eating window. Dietary intake timing and body weight will be monitored using digital tracking tools throughout the study period.
Receives: Behavioral: Scheduled Weight Maintenance Nutrition Education
Time-Restricted Eating (10-Hour Window)ExperimentalSame standardized sessions and monthly counseling as the control group, with the additional implementation of a 10-hour daily Time-Restricted Eating (TRE) regimen. Dietary intake timing and body weight will be monitored using digital tracking tools throughout the study period.
Receives: Behavioral: Time-Restricted Eating (10-Hour Window)

What is being measured

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

  1. Weight change

    The measurement will be conducted using the InBody570 bioelectrical impedance analyzer

    Measured: At 0 (baseline), 2, 5, 8, 14, 20 and 26 months.

  2. Percentage of Participants Maintaining ≥5% Weight Loss from Baseline

    The proportion of participants who achieve and sustain at least a 5% reduction in their baseline body weight by the end of the study. A participant is considered successful if their weight at 12 months is ≥5% lower than their weight at baseline.

    Measured: At 14, 20, and 26 months

Secondary outcomes (57)

  1. Change in waist circumference

    Measurements will be taken using the same model of standardized soft measuring tape.

    Measured: At 0 (baseline), 2, 5, 8, 14, 20 and 26 months.

  2. Change in hip circumference

    Measurements will be taken using the same model of standardized soft measuring tape.

    Measured: At 0 (baseline), 2, 5, 8, 14, 20 and 26 months.

  3. Change in body composition

    The body composition of patients will be measured using the InBody570 bioelectrical impedance analyzer, assessing key parameters (e.g., body mass index [BMI], fat mass [FM], fat-free mass [FFM], skeletal muscle mass [SMM], visceral fat area [VFA], total body water [TBW], extracellular water [ECW], intracellular water [ICW], basal metabolic rate [BMR], waist-hip ratio [WHR], and phase angle [PhA]).

    Measured: At 0 (baseline), 2, 5, 8, 14, 20 and 26 months.

  4. Change in blood pressure (systolic pressure and diastolic pressure)

    Measurements will be taken using the same brand and model of precision blood pressure monitor.

    Measured: At 0 (baseline), 2, 5, 8, 14, 20 and 26 months.

  5. Change in heart rate

    Measurements will be taken using the same brand and model of precision blood pressure monitor.

    Measured: At 0 (baseline), 2, 5, 8, 14, 20 and 26 months.

  6. Change in handgrip strength

    The handgrip strength of patients will be assessed using handgrip dynamometers of the same brand and model.

    Measured: At 0 (baseline), 2, 5, 8, 14, 20 and 26 months.

  7. Changes in blood transcriptomics

    Transcriptomic sequencing will be performed on blood samples collected from the patients to observe changes in blood transcriptional levels.

    Measured: At 0 (baseline), 2, 8 and 14 months.

  8. Changes in metabolomics in serum and feces

    Metabolomic sequencing will be performed on serum and fecal samples collected from the patients to observe changes in metabolic levels.

    Measured: At 0 (baseline), 2, 8 and 14 months.

  9. Change in quality of sleep measured by the Pittsburgh Sleep Quality Index (PSQI)

    The sleep quality of each patient will be evaluated by the Pittsburgh Sleep Quality Index (PSQI), with scores ranging from 0 to 21, with higher scores indicating poorer sleep quality

    Measured: At 0 (baseline), 2, 5, 8, 14, 20 and 26 months.

  10. Change in appetite states measured by the Electronic Visual Analogue Scale (eVAS)

    Subjective appetite states were assessed using the Electronic Visual Analogue Scale (eVAS), with scores ranging from 0 to 100 for each dimension (hunger, fullness, desire to eat, and estimated food intake). Higher scores indicate stronger sensations.

    Measured: At 0 (baseline), 2, 5, 8, 14, 20 and 26 months.

  11. The DISC Personality Assessment

    The DISC Personality Assessment evaluates four dimensions: Dominance (D), Influence (I), Steadiness (S), and Conscientiousness (C), with higher scores indicating stronger behavioral tendencies in each domain.

    Measured: At 0 (baseline)

  12. Change in quality of life measured by the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Questionnaire

    Health-related quality of life was assessed using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire, with scores ranging from 0 to 100 across five domains (Physical Function, Self-Esteem, Sexual Life, Public Distress, and Work Life). Higher scores indicate better weight-related quality of life.

    Measured: At 0 (baseline), 2, 8, 14 and 26 months.

  13. Change in fasting blood glucose

    Blood samples from the patients will be tested for fasting blood glucose levels.

    Measured: At 0 (baseline), 2, 8 and 14 months.

  14. Change in fasting insulin

    Blood samples from the patients will be tested for fasting insulin levels.

    Measured: At 0 (baseline), 2, 8 and 14 months.

  15. Change in glycated hemoglobin (HbA1c)

    Blood samples from the patients will be tested for glycated hemoglobin (HbA1c) levels.

    Measured: At 0 (baseline), 2, 8 and 14 months.

  16. Change in serum creatinine level

    Serum creatinine level will be measured from blood samples using an enzymatic method. Results will be reported in micromoles per liter (μmol/L).

    Measured: At 0 (baseline), 2, 8 and 14 months.

  17. Change in blood urea nitrogen level

    Blood urea nitrogen level will be measured from blood samples using the urease method. Results will be reported in millimoles per liter (mmol/L).

    Measured: At 0 (baseline), 2, 8 and 14 months.

  18. Change in serum uric acid level

    Serum uric acid level will be measured from blood samples using the uricase-ultraviolet method. Results will be reported in micromoles per liter (μmol/L).

    Measured: At 0 (baseline), 2, 8 and 14 months.

  19. Change in serum Alanine Aminotransferase (ALT) level

    Serum alanine aminotransferase (ALT) level will be measured from blood samples using a rate method. Results will be reported in units per liter (U/L).

    Measured: At 0 (baseline), 2, 8 and 14 months.

  20. Change in serum Aspartate Aminotransferase (AST) level

    Serum aspartate aminotransferase (AST) level will be measured from blood samples using a rate method. Results will be reported in units per liter (U/L).

    Measured: At 0 (baseline), 2, 8 and 14 months.

  21. Change in Aspartate aminotransferase to Alanine aminotransferase ratio (AST/ALT)

    The AST/ALT ratio (De Ritis ratio) will be calculated from the measured values of serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT). Results will be reported as a ratio.

    Measured: At 0 (baseline), 2, 8 and 14 months.

  22. Change in serum Gamma-Glutamyl Transferase (GGT) level

    Serum gamma-glutamyl transferase (GGT) level will be measured from blood samples using a rate method. Results will be reported in units per liter (U/L).

    Measured: At 0 (baseline), 2, 8 and 14 months.

  23. Change in serum Total Protein (TP) level

    Serum total protein (TP) level will be measured from blood samples using the biuret method. Results will be reported in grams per liter (g/L).

    Measured: At 0 (baseline), 2, 8 and 14 months.

  24. Change in serum Albumin (ALB) level

    Serum albumin (ALB) level will be measured from blood samples using the bromocresol green (BCG) method. Results will be reported in grams per liter (g/L).

    Measured: At 0 (baseline), 2, 8 and 14 months.

  25. Change in serum Globulin (GLOB) level

    Serum globulin (GLOB) level will be calculated by subtracting the measured serum albumin value from the measured serum total protein value. Results will be reported in grams per liter (g/L).

    Measured: At 0 (baseline), 2, 8 and 14 months.

  26. Change in Albumin to Globulin ratio (A/G)

    The Albumin to Globulin ratio (A/G) will be calculated from the measured values of serum albumin and calculated globulin. Results will be reported as a ratio.

    Measured: At 0 (baseline), 2, 8 and 14 months.

  27. Change in depression symptoms as measured by the Self-Rating Depression Scale (SDS)

    Depression symptoms will be assessed using the Self-Rating Depression Scale (SDS). The SDS total score ranges from 20 to 80, with higher scores indicating more severe depressive symptoms (worse outcome).

    Measured: At 0 (baseline), 2, 8, 14 and 26 months.

  28. Change in anxiety symptoms as measured by the Self-Rating Anxiety Scale (SAS)

    Anxiety symptoms will be assessed using the Self-Rating Anxiety Scale (SAS). The SAS total score ranges from 20 to 80, with higher scores indicating more severe anxiety symptoms (worse outcome).

    Measured: At 0 (baseline), 2, 8, 14 and 26 months.

  29. Change in serum Total Cholesterol (TC) level

    Serum concentration of Total Cholesterol (TC) will be measured from blood samples using the cholesterol oxidase method. Results will be reported in millimoles per liter (mmol/L).

    Measured: At 0 (baseline), 2, 8 and 14 months.

  30. Change in serum Triglycerides (TG) level

    Serum concentration of Triglycerides (TG) will be measured from blood samples using an enzymatic method. Results will be reported in millimoles per liter (mmol/L).

    Measured: At 0 (baseline), 2, 8 and 14 months.

  31. Change in serum High-Density Lipoprotein Cholesterol (HDL-C) level

    Serum concentration of High-Density Lipoprotein Cholesterol (HDL-C) will be measured from blood samples using an enzymatic method. Results will be reported in millimoles per liter (mmol/L).

    Measured: At 0 (baseline), 2, 8 and 14 months.

  32. Change in serum Low-Density Lipoprotein Cholesterol (LDL-C) level

    Serum concentration of Low-Density Lipoprotein Cholesterol (LDL-C) will be measured from blood samples using an enzymatic method. Results will be reported in millimoles per liter (mmol/L).

    Measured: At 0 (baseline), 2, 8 and 14 months.

  33. Change in serum Interleukin-1 beta (IL-1β) level

    Serum concentration of Interleukin-1 beta (IL-1β) will be measured from blood samples using a standardized multiplex immunoassay. Results will be reported in picograms per milliliter (pg/mL).

    Measured: At 0 (baseline), 2, 8 and 14 months.

  34. Change in serum Interleukin-6 (IL-6) level

    Serum concentration of Interleukin-6 (IL-6) will be measured from blood samples using a standardized multiplex immunoassay. Results will be reported in picograms per milliliter (pg/mL).

    Measured: At 0 (baseline), 2, 8 and 14 months.

  35. Change in serum Interleukin-8 (IL-8) level

    Serum concentration of Interleukin-8 (IL-8) will be measured from blood samples using a standardized multiplex immunoassay. Results will be reported in picograms per milliliter (pg/mL).

    Measured: At 0 (baseline), 2, 8 and 14 months.

  36. Change in serum Interleukin-10 (IL-10) level

    Serum concentration of Interleukin-10 (IL-10) will be measured from blood samples using a standardized multiplex immunoassay. Results will be reported in picograms per milliliter (pg/mL).

    Measured: At 0 (baseline), 2, 8 and 14 months.

  37. Change in serum Tumor Necrosis Factor-alpha (TNF-α) level

    Serum concentration of Tumor Necrosis Factor-alpha (TNF-α) will be measured from blood samples using a standardized multiplex immunoassay. Results will be reported in picograms per milliliter (pg/mL).

    Measured: At 0 (baseline), 2, 8 and 14 months.

  38. Change in serum Transforming Growth Factor-beta (TGF-β) level

    Serum concentration of Transforming Growth Factor-beta (TGF-β) will be measured from blood samples using a standardized multiplex immunoassay. Results will be reported in picograms per milliliter (pg/mL).

    Measured: At 0 (baseline), 2, 8 and 14 months.

  39. Change in serum Monocyte Chemoattractant Protein-1 (MCP-1/CCL2) level

    Serum concentration of Monocyte Chemoattractant Protein-1 (MCP-1/CCL2) will be measured from blood samples using a standardized multiplex immunoassay. Results will be reported in picograms per milliliter (pg/mL).

    Measured: At 0 (baseline), 2, 8 and 14 months.

  40. Change in serum Leptin level

    Serum concentration of Leptin will be measured from blood samples using a standardized immunoassay. Results will be reported in nanograms per milliliter (ng/mL).

    Measured: At 0 (baseline), 2, 8 and 14 months.

  41. Change in serum Adiponectin level

    Serum concentration of Adiponectin will be measured from blood samples using a standardized immunoassay. Results will be reported in micrograms per milliliter (μg/mL).

    Measured: At 0 (baseline), 2, 8 and 14 months.

  42. Change in serum C-reactive Protein (CRP) level

    Serum concentration of C-reactive Protein (CRP) will be measured from blood samples using an immunoturbidimetric assay. Results will be reported in milligrams per liter (mg/L).

    Measured: At 0 (baseline), 2, 8 and 14 months.

  43. Change in serum Tumor Necrosis Factor-alpha-induced protein 3 (TNFAIP3/A20) level

    Serum concentration of Tumor Necrosis Factor-alpha-induced protein 3 (TNFAIP3/A20) will be measured from blood samples using a standardized enzyme-linked immunosorbent assay (ELISA). Results will be reported in nanograms per milliliter (ng/mL).

    Measured: At 0 (baseline), 2, 8 and 14 months.

  44. Change in plasma Lipopolysaccharide (LPS) level

    Plasma concentration of Lipopolysaccharide (LPS) will be measured from blood samples using a commercial enzyme-linked immunosorbent assay (ELISA) kit. Results will be reported in endotoxin units per milliliter (EU/mL).

    Measured: At 0 (baseline), 2, 8 and 14 months.

  45. Change in serum Lipopolysaccharide-Binding Protein (LBP) level

    Serum concentration of Lipopolysaccharide-Binding Protein (LBP) will be measured from blood samples using a commercial enzyme-linked immunosorbent assay (ELISA) kit. Results will be reported in micrograms per milliliter (μg/mL).

    Measured: At 0 (baseline), 2, 8 and 14 months.

  46. Change in serum Resolvin D1 (RvD1) level

    Serum concentration of Resolvin D1 (RvD1) will be measured from blood samples using liquid chromatography with tandem mass spectrometry (LC-MS/MS). Results will be reported in picograms per milliliter (pg/mL).

    Measured: At 0 (baseline), 2, 8 and 14 months.

  47. Change in serum Resolvin E1 (RvE1) level

    Serum concentration of Resolvin E1 (RvE1) will be measured from blood samples using liquid chromatography with tandem mass spectrometry (LC-MS/MS). Results will be reported in picograms per milliliter (pg/mL).

    Measured: At 0 (baseline), 2, 8 and 14 months.

  48. Daily Energy and Macronutrient Intake

    Total energy intake and macronutrient distribution (percentage of energy from carbohydrates, fat, and protein) will be assessed at each time point using three non-consecutive 24-hour dietary recalls. Results will be reported in kilocalories (kcal) for energy and percentage points (%) for macronutrient distribution.

    Measured: At 0 (baseline), 2, 5, 8 14, 20, and 26 months.

  49. Within-individual variability in daily interstitial glucose (SD)

    Variability in daily interstitial glucose will be assessed using the standard deviation (SD) of mean daily glucose values across the continuous glucose monitoring (CGM) period. This metric quantifies day-to-day fluctuation in glucose concentration. Results will be reported in milligrams per deciliter (mg/dL).

    Measured: At months 2, 8, and 14. Each assessment will be conducted using continuous glucose monitoring (CGM) over a consecutive 14-day period.

  50. Within-individual variability in daily interstitial glucose (CV)

    Variability in daily interstitial glucose will be assessed using the coefficient of variation (CV), calculated as the standard deviation divided by the mean glucose level across the CGM period. This metric quantifies relative variability in glucose concentration. Results will be reported as a percentage (%).

    Measured: At months 2, 8, and 14. Each assessment will be conducted using continuous glucose monitoring (CGM) over a consecutive 14-day period.

  51. Mean amplitude of glycemic excursions (MAGE)

    Variability in daily interstitial glucose will be assessed using mean amplitude of glycemic excursions (MAGE), which represents the average magnitude of significant glucose fluctuations across the CGM period. This metric quantifies short-term glycemic variability. Results will be reported in milligrams per deciliter (mg/dL).

    Measured: At months 2, 8, and 14. Each assessment will be conducted using continuous glucose monitoring (CGM) over a consecutive 14-day period.

  52. Percentage of monitoring time with interstitial glucose 70-140 mg/dL (TIR)

    Glycemic control will be assessed as the percentage of total monitoring time spent in the target glucose range of 70-140 mg/dL during CGM. This metric quantifies the proportion of time glucose values remain within the predefined range. Results will be reported as a percentage (%).

    Measured: At months 2, 8, and 14. Each assessment will be conducted using continuous glucose monitoring (CGM) over a consecutive 14-day period.

  53. Change in postprandial glucose excursion

    The magnitude of postprandial glucose excursion will be assessed using continuous glucose monitoring (CGM), calculated as the difference between the peak interstitial glucose concentration and the pre-prandial level following main meals. Glucose data will be time-synchronized with self-reported dietary intake logs. Results will be reported in millimoles per liter (mmol/L).

    Measured: At 2, 8, and 14 months.

  54. Change in postprandial time above range (pTAR)

    The percentage of time that interstitial glucose concentrations exceed 10.0 mmol/L during the 3-hour postprandial period will be assessed using continuous glucose monitoring (CGM). Glucose data will be time-synchronized with self-reported dietary intake logs. Results will be reported as a percentage of the postprandial monitoring period (%).

    Measured: At 2, 8, and 14 months.

  55. Change in thyroid-stimulating hormone (TSH)

    Serum TSH levels will be measured from blood samples. Results will be reported in milli-international units per liter (mIU/L).

    Measured: At 0 (baseline), 2, 8 and 14 months.

  56. Change in free thyroxine (FT4)

    Serum FT4 levels will be measured from blood samples. Results will be reported in picomoles per liter (pmol/L).

    Measured: At 0 (baseline), 2, 8 and 14 months.

  57. DNA Methylation Patterns

    Genome-wide DNA methylation profiles will be assessed using peripheral blood samples collected at specified time points. Changes in DNA methylation will be explored as potential mechanistic biomarkers mediating the effects of time-restricted eating on metabolic health and weight regulation.

    Measured: At 0 (baseline), 2, 8, and 14 months.

Timeline

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

  1. First posted9 Sep 2025
  2. Study start26 Jan 2026
  3. Primary completionJan 2028 (estimated)
  4. Study completionJul 2028 (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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07163455
Sponsor's protocol ID
HMUIRB2025066PRE
Status last verified
Aug 2026
First submitted
14 Aug 2025
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jakubowicz D, Barnea M, Wainstein J, Froy O. High caloric intake at breakfast vs. dinner differentially influences weight loss of overweight and obese women. Obesity (Silver Spring). 2013 Dec;21(12):2504-12. doi: 10.1002/oby.20460. Epub 2013 Jul 2.

    PubMed 23512957

  • Mentzelou M, Papadopoulou SK, Psara E, Voulgaridou G, Pavlidou E, Androutsos O, Giaginis C. Chrononutrition in the Prevention and Management of Metabolic Disorders: A Literature Review. Nutrients. 2024 Mar 1;16(5):722. doi: 10.3390/nu16050722.

    PubMed 38474850

  • Wilkinson MJ, Manoogian ENC, Zadourian A, Lo H, Fakhouri S, Shoghi A, Wang X, Fleischer JG, Navlakha S, Panda S, Taub PR. Ten-Hour Time-Restricted Eating Reduces Weight, Blood Pressure, and Atherogenic Lipids in Patients with Metabolic Syndrome. Cell Metab. 2020 Jan 7;31(1):92-104.e5. doi: 10.1016/j.cmet.2019.11.004. Epub 2019 Dec 5.

    PubMed 31813824

  • Reytor-Gonzalez C, Simancas-Racines D, Roman-Galeano NM, Annunziata G, Galasso M, Zambrano-Villacres R, Verde L, Muscogiuri G, Frias-Toral E, Barrea L. Chrononutrition and Energy Balance: How Meal Timing and Circadian Rhythms Shape Weight Regulation and Metabolic Health. Nutrients. 2025 Jun 27;17(13):2135. doi: 10.3390/nu17132135.

    PubMed 40647240

  • Liu HY, Eso AA, Cook N, O'Neill HM, Albarqouni L. Meal Timing and Anthropometric and Metabolic Outcomes: A Systematic Review and Meta-Analysis. JAMA Netw Open. 2024 Nov 4;7(11):e2442163. doi: 10.1001/jamanetworkopen.2024.42163.

    PubMed 39485353

  • Duez H, Staels B. Circadian Disruption and the Risk of Developing Obesity. Curr Obes Rep. 2025 Feb 13;14(1):20. doi: 10.1007/s13679-025-00610-6.

    PubMed 39939483

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Questions about this trial

What is this clinical trial studying?

A study testing Scheduled Weight Maintenance Nutrition Education and Time-Restricted Eating (10-Hour Window) in people with Overweight or Obese Adults, run by Harbin Medical University at 10 sites 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 4 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites 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?

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?

Weight change (time frame: At 0 (baseline), 2, 5, 8, 14, 20 and 26 months.). 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?

On the ClinicalTrials.gov record for NCT07163455, which also lists 16 linked publications.

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 25 Aug 2026.

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