Effects of Time-Restricted Feeding on Blood Sugar Levels
Study to Evaluate the Effects of Time-Restricted Feeding Regimen in Overweight/Obese Subjects With Impaired Glucose Regulation
This study tests if a specific eating schedule can help people with blood sugar issues feel better and improve their health over a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Xiamen University Academic / other |
| Locations | 1 site (Xiamen, Fujian) |
| Trial ID | NCT03802253 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the impact of a Time-Restricted Feeding (TRF) regimen on individuals with impaired glucose regulation compared to those receiving standard care over a 12-month period. Participants will be monitored for changes in glucose levels and overall health outcomes. The study aims to determine if TRF can effectively improve glucose regulation in overweight or obese patients. The intervention involves structured eating windows and reduced calorie intake.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with impaired glucose regulation and a BMI between 23.0 and 45.0 kg/m2.
Not a fit: Patients with a confirmed diagnosis of diabetes or those on hypoglycemic treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel dietary strategy to improve glucose regulation and reduce the risk of diabetes in overweight and obese individuals.
How similar studies have performed: Other studies have shown promising results with time-restricted feeding approaches, suggesting potential effectiveness in managing glucose levels.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged ≥ 18 year 2. Diagnosis of impaired glucose regulation (i.e. FG between 5.7-6.9mmol/L) +/- impaired glucose tolerance (i.e. 2-hour postprandial PG between 7.8-11.1mmol/L) confirmed by latest OGTT results within 3 months prior to recruitment 3. Body mass index (BMI)of 23.0 to 45.0 kg/m2; Exclusion Criteria: 1. Confirmed diagnosis of DM or on hypoglycaemic treatment 2. Women who are pregnant or breast-feeding at recruitment 3. Patients taking glucocorticoid at recruitment 4. Active and uncontrolled thyroid diseases (including subjects on thyroid replacement therapy or anti-thyroid drugs) or active endocrine diseases such as Cushing's syndrome or Acromegaly at recruitment 5. Serious liver dysfunction or chronic kidney disease (AST or ALT \> 3 times the upper limit of normal, or eGFR\<30 ml/min/1.73 m2); 6. History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months; 7. Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician; 8. Currently participating in weight loss programs or weight change in the past 3 months (\> 5% current body weight) ; 9. Patients who cannot be followed for 24 months (due to a health situation or migration); 10. Patients who are unwilling or unable to give informed consent.
Where this trial is running
Xiamen, Fujian
- The first affiliated hospital of Xiamen university — Xiamen, Fujian, China (Recruiting)
Study contacts
- Study coordinator: Changqin Liu, MD&PhD
- Email: liuchangqin@xmu.edu.cn
- Phone: +8613376986106
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.